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.ManagementcommitmentandcontinualimprovementFUNDAMENTAL:
Thecompany"sseniormanagementshalldemonstratetheyarefullycommittedtotheimplementationoftherequirementsoftheSupplierQualificationProgram.Thisshallincludeprovisionofadequateresources,effectivecommunication,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。
1.1Doesthecompany"smanagementdefineproductsafetyandqualityobjectives?
贵公司管理层确定产品的安全和质量目标?
Moderate1.2Isthereviewofthemanagementsystemscarriedoutatleastannually?
是管理制度的检讨进行每年至少一次?
Minor1.3Doesthereviewofthemanagementsystemsincludeevaluationofthefollowingitems?
是否该管理系统的审查包括以下项目的评价?
1.3.1Resultsofaudits(internal,secondandthirdpartyaudits);审计结果(内部,第二和第三方审计)1.3.2Followupactionsfrompreviousmanagementreviews;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1.3.5Processperformanceandproductconformity;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1.3.8Riskmanagement;风险管理1.3.9Statutoryandregulatoryrequirements;法律法规要求1.3.10Resourceneeds;and资源需求,以及1.3.11Recommendationsforimprovement.改善建议Moderate1.4Arethedecisionsandactionsagreedduringthereviewcommunicatedeffectivelytoappropriatestaff?
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?
Minor1.6Doesthecompany"smanagementprovidethefollowingoverallresourcesrequiredtoimplementandimprovethequalitymanagementsystemandriskassessmentplan,andtoaddresslegal,productsafety,andproductqualitymatters?
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,transportetc)基础设施(如建筑物,设备,交通工具...等)1.6.3workenvironment工作环境1.6.4financialsupport财政支持Moderate1.7Doesthecompanyhaveaprocessinplacetoidentifyopportunitiesforimprovements?
公司是否制定一个过程,识别改进机会?
Minor2RiskManagementFUNDAMENTAL:
Thecompanyshallhaveaproductriskmanagementplan,basedonariskassessmentsystemwhichshallbesystematic,comprehensive,thorough,fullyimplementedandmaintained.Companiesmustbeawareofandmakereferencetoup-to-datelegislation,productstandards,codesofpracticeanddevelopmentsinscienceortechnologythatmayimpacttheriskconcerningtheirproductsandpackagingwheretheseexistinthecountriesofintendedsale.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,彻底的,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。
2.1LegislativeandSafetyRequirements2.1.1Isthecompanyawareofrelevantlegislation,mandatorystandardsandindustry/customercodesofpracticeapplicabletotheproductinthecountriesofintendedsale?
Moderate2.1.2Doesthecompanyhaveameanofvalidatinginformationimpactingproductsafety,qualityandlegality,wheresuchinformationisprovidedbythecustomerorrelatedparty?
Minor2.1.3Doesthecompanyhaveaprocessinplaceforensuringitiskeptinformedofchangestorelevantlegislation,standardsetc?
Moderate2.2RiskAssessment2.2.1Doesthecompanyestablishaproductriskassessmentforeachproductoragroupofsimilarproducts,e.g.,FMEA?
Moderate
2.2.2Wheremanufacturingsiteshavenoresponsibilityforproductdesign,isthecompanyprovidedwithavalidatedcopyoftheproductriskassessment?
Moderate2.2.3Doestheproductriskassessmentaddressthefollowingaspectswhichhaveaneffectonproductsafetyandlegality?
2.2.2.1Usertypes(e.g.,newborn,youngchildren,vulnerablepeoplei.e.,elderly,disabilities)2.2.2.2Productuse(e.g.,behaviour,durability,userawareness,informationandadvice)Moderate2.2.4Doestheproductriskassessmentdeterminethefollowing?
2.2.3.1PossibleHazard/RiskIdentification(e.g.,Chemical,Physical,Regulatory);2.2.3.2Risklevelforeachidentifiedhazard/risk(e.g.,Severe,High,Moderate,Slight);2.3.3Whethertheriskisacceptableconsideringtheprobabilityorlikelihoodandtheseverityandpotentialconsequencesoftheeffectsonconsumersafety(e.g.,NotAcceptable,Reviewamp;Improve,Acceptable)Moderate2.2.5Doesthecompanyconductaprocessriskassessmentofhazardspotentiallyintroducedduringtheproduction,packagingorstorageprocesses?
Moderate2.2.6Doestheprocessriskassessmenttakethefollowingintoaccount?
2.2.6.1manufacturingparameterssuchaspressure,time,temperature2.2.6.3conditionsofequipment,moulds,dies,machinery2.2.6.4chemicals/materialsusedforequipment(e.g.lubricatingoilsandpaints)2.2.6.5calibrationofequipment2.2.6.6policiesonforeignbodycontamination(e.g.needles,metal,glassandbrittleplastics)2.2.6.7policiesonmicrobiologicalcontamination(e.g.hygieneoftoiletamp;canteen,pestcontrol)2.2.6.8personalprotectiveequipment(includingspecificclothingandfootwear)Moderate2.2.7Doestheprocessriskassessmentidentifythefollowing?
2.2.7.1Alistofpotentialriskorhazardsintheproductionprocess2.2.7.2Controlpointstomanagetheidentifiedrisktoacceptablelevel2.2.7.3Accept/rejectlimitsdefinedforeachcontrolpoint2.2.7.4CorrectiveactiontobetakenwhereaCCPisoutofcontrol2.2.7.5ResponsibilityofControlPoints2.2.7.6Recordsofmonitoringamp;reviewsModerate2.2.8Iftheassessmentresultedinunacceptablerisk,doesthecompanygobacktoproductdesignprocessorcustomerformodificationtoachieveacceptablerisk?
Moderate2.3VerificationofRiskAssessment2.3.1Istheverificationofriskassessmentcarriedoutpriortoproduction?
Moderate2.3.2Istheriskassessmentcarriedoutbycompetentpersonnel(internalorexternal)?
Moderate2.3.3Istheriskassessmentregularlyreviewed,atleastannuallyorwhenchangesmadetoproductdesignandmaterialsand/orkeymanufacturingprocesses?
Moderate2.3.4Whererequiredbylegislation,doesthecompanydocumentandverifytheidentity,qualificationsand/orlicenceofthepersonprovidingthesafetyrevieworriskassessment?
Major2.3.5Whererequiredbylegislationorwhenitisnecessarytoconfirmitssafetyorlegality,doestheriskassessmentincludethetestingresults(fromaqualifiedandaccreditedexternal/internallaboratory)ofarepresentativeproduct?
Major3QualityManagementSystem3.1PolicyStatementThecompany"sseniormanagementshalldevelop,documentandimplementapolicystatementwhichisauthorised,regularlyreviewed,signedanddatedbyanappropriateseniormanager.3.1.1Doesthecompanyestablishapolicystatementwhichhasbeencommunicatedandunderstoodbyallstaffinvolvedwithactivitiesimpactingproductsafety,legalityandquality?
Moderate3.1.2Doesthepolicystatementincludethefollowing?
3.1.2.1Thecompany"sintentiontoproducesafeandlegalproductstodefinedquality,andtomeetitsresponsibilitytoitscustomers;and3.1.2.2AcommitmentforreviewandcontinualimprovementMinor3.1.3Doesthecompanyperiodicallyreviewthepolicystatementforcontinuingsuitability?
Minor3.2GeneralDocumentationRequirements3.2.1ControlofDocumentThecompany"sseniormanagementshallensurethatalldocuments,recordsanddataimpactingthemanagementofproductsafety,legalityandqualityareinplaceandeffectivelycontrolled.3.2.1.1Doesthecompanyeffectivelycontrolalldocuments(internalandexternal)impactingproductsafety,legalityModerate
andquality?
3.2.1.2Areup-to-dateversionsofdocumentsavailableatpointsofuse?
Minor3.2.1.3Aredocumentlegible,unambiguous,inappropriatelanguagesandsufficientlydetailedtoenabletheircorrectapplicationbystaff?
Minor3.2.1.4Areobsoletedocumentsidentifiedandremovedfromuse?
Minor3.2.1.5Doesthecompanyrecordthedateandreasonforanychange/amendmenttodocumentsimpactingproductsafety,legalityorquality?
Minor3.2.2ControlofRecordThecompanyshallmaintainrecordstodemonstratetheeffectivecontrolandachievementofproductsafety,legalityandquality.3.2.2.1Doesthecompanyestablishproceduresforthecollation,review,maintenance,storageandretrievalofallrecordsimpactingproductsafety,legalityandquality?
Minor3.2.2.2Arerecordslegible,genuineandauthorised?
Minor3.2.2.3Arerecordsreadilyaccessible,securelystoredtopreventdamagedeterioration?
Minor3.2.2.4Arerecordsretainedinaccordancewithperiodsspecifiedbyacustomerorlegislation?
Moderate3.2.2.5Areanyalterationstorecordsjustifiedandauthorised?
Moderate3.2.3SpecificationsThecompanyshallensurethatspecificationsexistforrawmaterials,componentsandboughtinpartsincludingpackaging,intermediate/semi-processedandfinishedproductsandanyproductorservicewhichcouldaffecttheintegrityofthefinishedproduct.3.2.3.1Doesthecompanyestablishspecificationsforrawmaterials,components,andbought-in-partsincludingpackaging,intermediate/semi-processedandanyproductorservicewhichcouldimpacttheintegrityofthefinishedproduct?
Moderate3.2.3.2Isaspecificationofeachfinalproductdocumentedanddated?
Moderate3.2.3.3Doesthespecificationincludethefollowinginformation,whereapplicable?
3.2.3.3.1composition,size,colour3.2.3.3.2billofmaterials3.2.3.3.3assemblydiagrams3.2.3.3.4primarypackaging3.2.3.3.5intendedshelflife3.2.3.3.6warningsorinstructionsforuse3.2.3.3.7use,misuse,usagepatterns3.2.3.3.8productionvolumesModerate3.2.3.4Arespecificationsaccurateandcomplyingwithrelevantsafety,legislativeandcustomerrequirements?
Major3.2.3.5Arecurrentspecificationsaccessibletorelevantstaff?
Minor3.2.3.6Doesthecompanymaintaintechnicaldossierorpackagecontainingallrelevantdata(ordetailofwheresuchdataislocated)toensurethatproductsmeettheapplicablerequirements?
Moderate3.2.3.7Doesthetechnicaldossierorpackageincludethefollowinginformation:
3.2.3.7.1adetailedproductspecification3.2.3.7.2safetydatasheetsonchemicalsusedwhererelevanttothesafety,legalityorqualityoftheproduct3.2.3.7.3theriskassessment(s)3.2.3.7.4adescriptionoftheconformityassessmentprocedure;3.2.3.7.5testreports,inspectionreports3.2.3.7.6alistofthelegislation,productstandardswithwhichtheproductsaremanufacturedtocomply3.2.3.7.7productioncontrolproceduresandcharts3.2.3.7.8approvalsbyanygovernmentbody(ifapplicable)3.2.3.7.9declarationsofconformitytolegalrequirements(ifapplicable)Moderate3.2.3.8Arespecificationsformallyagreedwithrelevantparties(e.g.,signedoffbythecustomer)?
Wherespecificationsarenotformallyagreed,thecompanymustdemonstratethatithastakenstepstoseekformalagreement.Minor3.2.3.9Arespecificationsregularyreviewedatleastannuallytoensureitsadequacyandstatus?
Minor3.3ResponsibilityandAuthorityThecompanyshallhaveaclearlydefinedanddocumentedorganisationalstructurethatensurestheawarenessofjobfunction,responsibilitiesandreportingrelationshipsofkeystaff.3.3.1Istheorganisationalchartavailableandup-to-date?
Minor
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