Intertek-SQP_审核报告清单

第1页，共21页1.ManagementcommitmentandcontinualimprovementCL-SQPQuestionsQuestionRiskWeighting1.1Doesthecompany'smanagementdefineproductsafetyandqualityobjectives?Major1.2Isthereviewofthemanagementsystemscarriedoutleastannually?Minor1.3Doesthereviewofthemanagementsystemsincludeevaluationofthefollowingitems?1.3.1Resultsofaudits(internal,secondandthirdpartyaudits);1.3.2Followupactionsfrompreviousmanagementreviews;1.3.3CustomerComplaintsandfeedback;1.3.4Statusofpreventiveandcorrectiveactions;1.3.5Processperformanceandproductconformity;1.3.6ChangesthatcouldaffecttheManagementSystems1.3.7roductsafetyandqualityobjectives;1.3.8Riskmanagement;1.3.9Statutoryandregulatoryrequirements;1.3.10Resourceneeds;and1.3.11Recommendationsforimprovement.Major1.4Arethedecisionstakenandactionsagreedduringthereviewcommunicatedeffectivelytoappropriatestaff?Minor1.5Aretheactionsimplementedwithintheagreedtimescales?Minor1.6Doesthecompany'smanagementprovidethefollowingoverallresourcestoensureeffectivemanagementandperformanceofwork?1.6.1personnel1.6.2infrastructure(e.g.,building,equipment,transport…etc)1.6.3workenvironment1.6.4financialsupportMajor2RiskManagementSystems2.1LegislativeandSafetyRequirementsCL-SQPQuestionsQuestionRiskWeighting2.1.1Isthecompanyawareofrelevantlegislation,mandatorystandardsandindustry/customercodesofpracticeapplicabletotheproductinthecountriesofintendedsale?Major2.1.2Doesthecompanyhaveameanofvalidatinginformationimpactingproductsafety,qualityandlegality,wheresuchinformationisprovidedbythecustomerorrelatedparty?MinorFUNDAMENTAL:Thecompany'sseniormanagementshalldemonstratetheyarefullycommittedtotheimplementationoftherequirementsoftheSupplierQualificationProgram.Thisshallincludeprovisionofadequateresources,effectivecommunication,systemsofreviewandactionstakentoidentifyandeffectopportunitiesforimprovement.FUNDAMENTAL:Thecompanyshallhaveaproductriskmanagementplan,basedonariskassessmentsystemwhichshallbesystematic,comprehensive,thorough,fullyimplementedandmaintained.Companiesmustbeawareofandreferto;uptodatelegislation,productstandards,codesofpracticeanddevelopmentsinscienceortechnologythatmayimpacttheriskconcerningtheirproductsandpackagingwheretheseexistinthecountriesofintendedsale.第2页，共21页2.1.3Doesthecompanyhaveaprocessinplaceforensuringitiskeptinformedofchangestorelevantlegislation,standardsetc?Major2.2RiskAssessment(Documentation)CL-SQPQuestionsQuestionRiskWeighting2.2.1Doesthecompanyestablishaproductriskassessmentforeachproductoragroupofsimilarproducts,e.g.,FMEA?Major2.2.2Doestheproductriskassessmentaddressthefollowingaspectswhichhaveaneffectonproductsafetyandlegality?2.2.2.1Usertypes(e.g.,newborn,youngchildren,vulnerablepeoplei.e.,elderly,disabilities)2.2.2.2Productuse(e.g.,behaviour,durability,userawareness,informationandadvice)Major2.2.3Doestheproductriskassessmentdeterminethefollowing?2.2.3.1PossibleHazard/RiskIdentification(e.g.,Chemical,Physical,Regulatory);2.2.3.2Risklevelforeachidentifiedhazard/risk(e.g.,Severe,High,Moderate,Slight);2.2.3.3Whethertheriskisacceptableconsideringtheprobabilityorlikelihoodandtheseverityandpotentialconsequencesoftheeffectsonconsumersafety(e.g.,NotAcceptable,Review&Approve,Acceptable)Major2.2.4Wheremanufacturingsiteshavenoresponsibilityforproductdesign,isthecompanyprovidedwithavalidatedcopyoftheproductriskassessment?Major2.2.5Doesthecompanyconductaprocessriskassessmentofhazardspotentiallyintroducedduringtheproduction,packagingorstorageprocesses?Major2.2.6Doestheprocessriskassessmenttakethefollowingintoaccount?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.hygieneoftoilet&canteen,pestcontrol)2.2.6.8personalprotectiveequipment(includingspecificclothingandfootwear)Major2.2.7Doestheprocessriskassessmentidentifythefollowing?2.2.7.1Alistofpotentialriskorhazardsintheproductionprocess2.2.7.2Controlpointstomanagetheidentifiedrisktoacceptablelevel2.2.7.3Accept/rejectlimitsdefinedforeachcontrolpoint2.2.7.4CorrectiveactiontobetakenwhereaCCPisoutofcontrol2.2.7.5ResponsibilityofControlPoints2.2.7.6Recordsofmonitoring&reviewsMajor2.2.8Iftheassessmentresultedinunacceptablerisk,doesthecompanygobacktoproductdesignprocessorcustomerformodificationtoachieveacceptablerisk?Major2.3VerificationofRiskAssessmentCL-SQPQuestionsQuestionRiskWeighting2.3.1Istheverificationofriskassessmentcarriedoutpriortoproduction?Major2.3.2Istheriskassessmentcarriedoutbycompetentpersonnel(internalorexternal)?Major2.3.3Istheriskassessmentregularlyreviewed,atleastannuallyorwhenchangesmadetoproductdesignandmaterialsand/orkeymanufacturingprocesses?Major第3页，共21页2.3.4Whererequiredbylegislation,doesthecompanydocumentandverifytheidentity,qualificationsand/orlicenceofthepersonprovidingthesafetyrevieworriskassessment?Critical2.3.5Whererequire