产品风险评估报告一览表

产品风险评估报告一览产品风险评估报告一览表产品风险评估报告一览表DepartmentInvolved:R&DDepartment(开发工程)/ProductionDepartment(生产工程)、MaterialControlDepartment(物料部)、PurchasingDepartment(采买部)、QualityDepartment(品管部)Preparedby(组织人员):ResponsibleEngineer(工程师):Date(日期):ItemNameandNo.(产品名称/编号):Customer(客户):AgeGrade(适应年纪)：SaleRegion(销售地域):(A)Mechanical(物理和机械性)No.CheckPointDescription评审项目Result评估结果SharpPointandProtrudingparts(利角及突出物)(PunctureHazard)Capableofcausingpuncturesoftheskin.（可致使刺伤皮肤）Checkforexistenceofpointswithacrosssectionof2mmorless.（存在横截面等于或小于2mm的尖点）1Checkforexistenceofmetallicwiresandothermetalliccomponentsthataredesignedandintendedtobebentandmetallicwireslikelytobebent.（存在曲折的金属线或其余金属组件）Endprotectionshouldbegivenasufficientlylargesurfaceareatoavoidpuncturingofthebody.（尾端应当覆盖足够大的表面积，防止刺穿。）23SharpEdge(利边)Accessibleedgesthatarelikelytocauseinjury(noexposedsharpplasticormetaledges)存在可致使受伤的可接触边（需无批锋、金属边）SmallPart（小物品）(Choking,IngestionandInhalationHazards)(3Y-)（窒息/吸入危害）Possibilityofproducingsmallpartswhenbrokenthatfitscompletelyintothesmallparttestcylinder(dim.>31.7mm)–eg.Wheelsthatcomeoffcars,buttonsandeyesthatfalloffdollsorplushtoys.（产品存在可放入小物品筒的可拆卸物品、零落物品。如：从车子上零落的轮胎，从玩偶或毛绒玩具上零落的纽扣和眼镜。）456SmallBall(Choking,IngestionandInhalationHazards)(3Y-)AnyballthatshouldnotentirelypassesthroughtemplateE(dia.44.5mm).（任何球都不应当完整经过模板E）（直径）Housingforsmallball/beadshouldhaveenoughstrengthtowithstandabusetest.SuctionCup(吸盘)(3Y-)ShallnotprotrudepastthroughtemplateE(dia.44.5mm).（吸盘柄不行突出经过模板E）Rattle,Squeezetoy,TeetherorHand-heldactivitytoys(10M-)-EUNopartofthetoy(otherthansoft-filledpart)shallprotrudepastthebaseoftemplateAexceptthemassofthetoyisgreaterthan0.5Kg.（玩具零件不行突出经过模板A，除非玩具重量大于。）less,nopartofthetoyshallprotrudepastthebaseoftemplateB(质量等于或小于的近球体，半球体或圆头不行突出经过模板B）Rattle,Squeezetoy(18M-)orTeether-US7Nopartofthetoy(otherthansoft-filledpart)shallprotrudepastthebaseoftemplateA.Thenearlyspherical,hemisphericalorcircularflaredendsshallprotrudepastthebaseoftemplateB（玩具零件不行突出经过模板A，近球体，半球体或圆头不行突出经过模板B）Round,SphericalorHemisphericalend(18-48M)（球体或半球体尾端）8TheroundedendshallnotprotrudepastthebaseoftemplateB(dia.42.7mm,depth30mm)iftheproduct’sweightislessthan0.5Kg.（假如产品重量小于，则圆头不可以突出经过模板B（直径，深度30mm））CribToy(挂床玩具)9Shallnothavehazardousprotrusionsthatcouldcontributetoentanglementinjury.（不该当有可致使环绕而造成危害的突出物）Cord(绳子)(StrangulationandEntanglementHazards)(3Y-)Thickness（厚度）FreeLength（净长度）:<220mmwhenstretchedbyaforceof(252)N±.（<220mm，10当用（25±2）N的力拉伸时）Whensubjectedtoaforceof(252)±N,separateintopartsnotexceeding220mmwhenstretchedbyaforceof(252)N±.（当以（25±2）N的力拉伸时，绳子不得分红擅长220mm）Perimeter（周长）:<380mmwhenstretchedbyaforceof(252)N±.Magnet(磁石)(Choking,IngestionandInhalationHazards)(3Y-)（窒息或吸入危害）11Possibilityofproducingsmallmagnetwhenbrokenthatfitscompletelyintothesmallparttestcylinder(dim.>31.7mm)（产品可拆卸或零落的小磁铁可完整投入小物品筒）GapandSpacing(空隙)(FingerTrapHazard)Drivingmechanisms(传动机构)-Clearspacebetweenthekeyorthehandleandthe<5mmdiameter.（空隙一定>13mm或5mm）Hinge(铰链)-Spacingbetweenpartsjointedbyhingeshallbeeither>13mmor<512mmiftheparts>200g.假如零件重量>200g，则铰链联合处的空隙>13mm或5mm。）Wheel(车轮)-Spacesbetweenthewheelsandthebodyorpartsofthebodyshallbeeither>13mmor<5mm（车轮、车身或车身部位的空隙需>13mm或<5mm。）FoldingorSlidingmechanisms(折叠装置)-Spacebetweenmovingelementsoftoywithfoldingorslidingmechanismsintendedtobearorcapableofbearingthemassofachildshallbeeither>13mmor<5mm（可以蒙受一个小孩重量的折叠装置玩具的空隙需>13mm或5mm）131415CircularHole(圆孔)(FingerTrapHazard)either<6mmor>13mmindiameterifdepth>10mm.（厚度小于的钢性资料上的可涉及的圆孔，直径需<6mm或13mm，深度需>10mm）JawEntrapment(颌骨危险)(18M-)Scope:Activitytables,Largebulkytoy,Stationaryfloortoy,Pushtoy,Ride-ontoy.（范围：活动桌椅，大型粗笨玩具，可固定站立玩具，推进玩具，骑乘玩具。Openingsinhandles张口或方向盘不单可经过一个长宽为19mm，高大于13mm的方块，还应可经过一个长为38mmProjectile(弹射玩具)（子弹半径>2mm.子弹表面需为软材质）Designshouldnotabletodischargemissilesotherthanthoseprovidedwiththetoy.（射弹玩具需配有专用子弹，不行换用其余子弹）Durability(牢固)(MechanicalHazards)NoSmallParts,SharpEdgesorSharpPointsafterbelowabusetests(3Y-).（滥用测试后16无尖点、利边、小物品。）DropTestTensionTestTorqueTestImpactTestCompressionTestStabilityTestTipOverTestSeamStrengthTestFlexibilityofwiresTestAcoustic(声响)Close-to-Ear(80dBAat2.5cm)RattleandHand-held(85dBAat50cm,110dBCat50cm)Table-topandFloor(110dBCat50cm)PlasticBag（胶带）18Thicknessshouldbe>0.038mm.厚度应>0.038mm.Warning(警示语)19SmallPartSmallBallEntanglementorStrangulationMechanicalStrengthMagnetProjectileToyAquaticToyAdultAssemblyAdultSupervision(B)Flammability(易燃性)No.CheckPointDescription评审项目Result评估结果PlasticandTextile塑料和纺织品1.Donotburnifdirectlyexposedtoaflameorsparkorotherpotentialseatoffire.（直接接触火焰、火光或其余潜伏火源需不行燃。）2.Notreadilyflammable(theflamegoesoutassoonastheignitionsourceisremoved).不易燃（一但火源移开，火焰需立刻自行熄灭。）3.Iftheydoignite,burnslowlyandpresentalowrateofspreadoftheflame.（烧迟缓或火焰延伸速度慢）No.123456(C)Chemical(化学性)CheckPointDescription评审项目Result评估结果ToxicChemicals(有毒物质)AllcomponentsmustcomplywithRoHSrequirement.（全部件需切合ROHS。）HeavyMetals(重金属)AllcomponentsmustcomplywithEN71part3requirement.（全部零件需切合En71第3部分的要求）TotalLead(总铅含量)AllcomponentsmustcomplywithCPSIAtotalleadrequirement.（全部零件需切合CPSIA对于含量的要求）Phthalate(邻苯二甲酸盐)AllcomponentsmustcomplywithEUphthalaterequirement.（全部零件需切合EU对于邻苯二酸盐的要求）DangerousSubstances(危害物质)AllcomponentsmustcomplywithREACHrequirement.（全部零件需切合REACH要求）AzoDyes(偶氮染料)Alltextilemustcomplywithdirective2002/61/ECrequirement.全部纺织品需切合2002/61/EC的指导要求）AllergenicFragrances（芬芳剂过敏）Presenceoffragrancebutatconcentrationsnotexceeding100mg/kg.（所使用的芬芳剂浓度不可以超出100mg/kg。）Presenceoffragrancewithconcentrationsexceeding100mg/kgandlabeltogetherwithwarningonpackageisneeded.（所使用的芬芳剂浓度超出100mg/kg时，需在包装上贴警示语）(D)ElectricShock(电气性能)No.CheckPointDescription评审项目Result评估结果NominalVoltage(电压)1Nopartshouldexceed24volts（不得超出24V）HeatSource(热源)SingleComponentFaultTest.（单个零件故障测试）2BatteryReversalTest（电池反装测试）BatterycompartmentsteelpinShort-CircuitTest（电池短路测试）ShortCircuitofclearancesandcreepagedistancesbetweenpartsofdifferentpolarity.（不一样极性的配件之间短路的空隙及爬电距离）Marking&Instruction(标志及指示)345BatteryShape（电池型号）arityNominalVoltageTransformerRateVoltageAC/DCsymbolWEEEsymbolBatteryInstallationInstructions（电池安装说明）ReplaceableBatteryInstructions（可改换电池说明）AssemblyInstructions（组装说明）DurabilityofMarking（标签长久性）Rubthemarkingbyhandfor15swithapieceofclothsoakedwithwaterandagainfor15swithapieceofclothsoakedwithpetroleumspirit.（用一块用水浸泡过的布条摩擦10S再用一块用酒精浸泡过的布条摩擦10S）RechargeableBattery（可充电电池）Itshallnotbepossibletochargerechargeablebatterieswhentheyareinthetoyunlessitisnotpossibletooperatethetoyduringcharging.（不可以使用可充电电池，除非玩具在充电过程中不可以运转/嬉戏。）(E)Radiation(放射性)No.ResultCheckPointDescription评审项目评估结果HarmfulRadiation（有害辐射）LEDintoyshouldmeettherequirementforClassIlasersinaccordancewithEN60825-1.(玩具上的LED一定切合EN60825-1的要求。)hygiene(卫生性)No.CheckPointDescription评审项目Result评估结果Material(物料)1AllMaterialmustbenewandclean.（全部的物料一定是新的、洁净的。）Cleaning（洁净）2Toysforchildrenunder36monthsmustdesignedandmanufacturedinsuchawaythatitcanbecleaned.SurfaceWash（表面洁净）SoakWash（浸泡冲洗）（全部为36M一下小孩和制造的玩具一定是可洁净的）Fluid（流体）3Fluidmustbefreeofbiologicalcontaminants（流体一定无生物污染物）CommentontheStructureNo.Comment（建议）12ApplicableStandards合用DirectiveNo.DirectiveName:2009/48/EC2004/108/EC2002/95/EEC2002/96/EEC2005/84/ECDirectiveoftheEuropeanParliamentandoftheCouncilonthesafetyoftoys.欧盟议会和玩具安全委员会的指令EMCDirective.（电磁兼容性指令）RestrictionoftheuseofCertainHazardousSubstancesinElectricalandElectronicEquipment(RoHS).（某些有害物质在电气和电子产品上的使用限令。）?WasteElectrical&ElectronicEquipment(WEEE).（耗电/电子设施。）Standard:Issue:Title:EN71Part1EN71-1:2005andA9:2009Mechanicalandphysicalproperties（机械性能）EN71Part2EN71-2:2006+A1:2007Flammability（易燃性）EN71Part3EN71-3:1994andamendmentMigrationoftoxicelements（有毒元素的转移）A1:2000andAC:2002EN62115EN62115:2005Safetyofelectrictoy（电子玩具的安全性）EN60825EN60825-1:1994+A1+A2Safetyoflaserproducts–Part1（激光产品的安全性）EMCEMC:EN55014-1:2006+A1ElectromagneticCompatibility–Part1:Emission（电磁兼容性）EMCEMC:EN55014-2:1997+A1+ElectromagneticCompatibility–Part2:ImmunityA22002/95/ECandamendmentDeterminationoflevelsofregulatedsubstancesinRoHSelectrotechnicalproducts2005/61/EC电子产品上的管束物质测定水平。Phthalate2005Phthalatecontentintoysandchildrenarticles邻苯二甲酸盐（玩具或小孩使用物品上的邻苯二甲酸盐含量）PRODUCTDESIGNEVALUATIONNo.Description1ComplianceFindings:Theproductshouldcomplywiththerequirementsforchildren6monthsandupbasedontheplayfeature,constructionanddesignaccordingtoEN71andEN62115.（供6M+小孩使用的产品需切合EN71和EN62115标准）Non-conformitywasnotidentifiedduringthisreview.（不合格产品将不被认可）2RiskAssessmentFindings:CriticalConcerns:（不行用）MajorConcerns:（严重）MinorConcerns:（稍微）危害评估Nocriticalconcernwasidentified.Nomajorconcernwasidentified.Nominorconcernwasidentified.AllincomingmaterialswillbeinspectedbyIQC（IQC对全部来料进行检查）Firstpiece/articlefrommanufacturingprocesswillbeinspectedbyIPQC34（IQC进行首件检查）CriticalManufacturingSemi-finishedproductwillbeinspectedbyoperatorinline.Concerns:（半成品将会安排人在生产线上检查）FinishedproductwillbeinspectedbyFQA.（QA对成品进行检查）OutgoingproductwillbeinspectedbyOQC.（QC对出货产品进行检查）RecallHistory退货Haveanyofthesametypeoftoyseverbeenrecalled?YesNo有任何同类产品被客户退过货吗？RESULTSOFDESIGNEVALUATION（设计评估结果）SeverityofInjurySERIOUSANDSERIOUSNOTSIGNIFICANTBUTNOTMINORPERMANENTPERMANENTPERMANENTProbabilityofNOTNOTNOTNOTinjurytotheendLIKELYconsumerbyusingACCEPTABLEACCEPTABLEACCEPTABLEACCEPTABLEthisproduct.NOTNOTNOTNOT（使用该产品顾客受POSSIBLEACCEPTABLEACCEPTABLEACCEPTABLEACCEPTABLE伤的可能性）UNLIKELYNOTNOTNOTXACCEPTABLEACCEPTABLEACCEPTABLEALMOSTNOTNOTIMPOSSIBLEACCEPTABLEACCEPTABLECONCLUSION（结论）5TheprobabilityofachildbeinginjuredbyusingthisproductisUNLIKELY”“andtheseverityisMINOR“”.Theconclusionofthisassessmentisthattheproductcanbeclassifiedassafe.（小孩使用该产品受伤的可能性是“不行能”且受伤程度是“稍微”。结论表示该产品安全。）Approvedby(核实人员):Position(职位):QualityManagerDate(日期):