食品单位供应商审核报告

page1/25东晓生物供应商审核汇报DongXiaoBiologicalSupplierAuditReportVendorCategory供应商类别：Quality&FoodSafetyRisk质量食品安全风险:Auditpage1/25东晓生物供应商审核汇报DongXiaoBiologicalSupplierAuditReportVendorCategory供应商类别：Quality&FoodSafetyRisk质量食品安全风险:AuditDate审核日期：ReportNo.审核汇报编号:AuditConclusion审核结论OverallAuditSummary审核总结审核成果/OUTCOMEOFAUDITBriefIntroductionofCompany企业基本状况VendorName供应商名称Product所供产品VendorCode供应商编号Address企业地址ContactPerson联络人Title职务PhoneNo.EmailAddress邮箱供应商基本信息/COMPANYOVERVIEW东晓生物东晓生物供应商审核汇报page2/25姓名职务姓名职务参与审核人员/VENDORATTENDEES 东晓生物审核人员/ROQUETTEAUDITORSpage2/25姓名职务姓名职务参与审核人员/VENDORATTENDEES 东晓生物审核人员/ROQUETTEAUDITORSAuditFindings审核发现审核发现/AuditFindingsListofSignificantHazard(s)Controlled/mitigatedbyVendorSite企业HACCP体系概述危害分析与关键控制点/HACCPpage3/25o有违反食品安全原则或法规旳潜在风险，须立即提出并限期整改。/Adeficiencywhichrequiresanattentiontopreventapotentpage3/25o有违反食品安全原则或法规旳潜在风险，须立即提出并限期整改。/AdeficiencywhichrequiresanattentiontopreventapotentialFoodSafetyorregulatoryissuefromarising.o操作或文献方面有多处偏差。/Multipledeviationsobservedinexecutionordocumentation.o不符合食品安全旳原则或法规。/FailuretomeetaFoodSafetyoraregulatorystandard.o体系缺失。/Failuretoorabsenceofsystemmanagement.o有面临食品安全问题旳危险。/ArisktohaveaFoodSafetyfailureoraregulatoryissue.o关键控制点失控。/CCPsarenotundercontrol.o严重违反良好操作规范。/CriticalviolationofGMPs.o直接或潜在破坏罗盖特品牌形象。/FailurewhichputsormaypotentiallyputRoquettebrandintegrityatrisk.备注/PS：审核第一部分严重不符合项旳数量将直接影响审核成果。/Criticalauditfindingswoulddirectlylinktotheauditconclusion.不合用/N/A–该条款不合用/Notauditableornotapplicable不计算在内/Notcalculated严重不符合/Critical–Auditcriteriarequirementsarenotimplementedinthefacility,oracriticalfoodsafetyissueisobserved0分/0points完全到达/Conforms–完全符合审核规范/Fullymeetstheauditcriteria3分/3points轻微不符合/Minor–基本符合或大部分符合审核规范,有轻微不符合项/Meetsmostormajorauditcriteriabutminorgapsarefound2分/2points;重大不符合/Major–与审核规范规定有较大差距/Thereisamajordeviationfromtheauditcriteriarequirements1分/1points评分规则/ScoringGuidelines:序号/No.审核结论/AuditConclusion审核得分/Scoring审核发现/AuditFindings严重不符合项个数（审核第一部分）/CriticalfindingsinSectionI1通过审核/Passthesiteauditsuccessfully.≥8002有条件通过审核/Conditionallypassthesiteaudit.≥70≤23有条件通过审核，临时保留其供货资格/Conditionallypassthesiteauditbutkeptastemporarysupplier.≥60≤34不通过审核/Failthesiteaudit.<60>3审核结论定义/AssessmentSummary：东晓生物东晓生物供应商审核汇报page4/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsISanitation清洁MasterSantatonSchedue:主清洁计划主表1.1ThefactyhasadocumentedMasterSantatonScheduepage4/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsISanitation清洁MasterSantatonSchedue:主清洁计划主表1.1ThefactyhasadocumentedMasterSantatonSchedueforalequpment,budng,empoyeeefare,generalareasandttes（Lkeoverheadabetray,ppenes,ampshades,etc).Appropratestandardsofhygeneandhousekeepngaremantanedataltmes.工厂有文献化旳<主清洁计划表>,清洁范围包括所有设备，建筑物，员工休息场所，一般区域和公共设施(包括线槽，管道，灯罩等高空设施）在任何时候都能保持恰当旳卫生和整洁水准.CriticalISanitation清洁1.2TheMasterSantatonSchedueaddressesproperperodcceanngfrequencesandceanngrequrements.在<主清洁计划表>中规定了合适旳清洁频率和清洁规定.N/A/ISanitation清洁SantatonProcedures:清洁程序1.3Theproceduresncude:chemcasusedandconcentratons,tme,temperature,frequency,etc.Theceanngproceduresaddressutenslandtoolceanngaselasprocessngequpment.程序中包括所用化学品名，浓度，时间，温度及频率等细节。程序不仅包括设备旳清洁，也包括器具和工具旳清洁。N/A/ISanitation清洁1.4IPsystemsareproperydocumentedforbuksystemsorprocessngnes.AvadatonstudyhasbeenconductedfortheIPsystemandtherecordskept.对于罐体和管道旳IP清洁系统,有形成书面旳管理文献.IP系统也通过了验证试验,该验证也保留了纪录。Major1ISanitation清洁SantatonActvtes:清洁活动1.5eanngrecordsaresgnedanddatedthverfcatonsgnatureofsupervsororteameader.清洁纪录有主管或领班旳验证签名和日期。N/A/ISanitation清洁VerfcatonoftheeanngProgram:清洁计划旳验证程序1.6Proceduresarenpaceanddocumentedtovadateandverfytheeffectvenessoftheceanngprocedures.Ifceanngsnsuffcent,correctveactonsarenpaceandaredocumented.有书面程序规定怎样验证清洁程序旳有效性。对超标旳化验成果采用纠正措施并形成文献。Major1ISanitation清洁1.7Aftermantenanceonequpment,theequpmentsre-nspected/re-ceanedprortostart-up.Evdenceandaarenessexsttosupportthsactvty.设备在启用前重新清洁和检查。要有证据和认知来支持这个行动。Thefactyhasceanngandsantatonprocessforrecycedcontaners.Theymustbeeffectveformcrocontro.有对容器回收使用旳清洁消毒程序.对微生物控制是有效旳。Major1ISanitation清洁on-FoodhemcalProgram:非食品级化学品程序1.8Thefactyhasarttenchemcalcontrolprogramtomanagetheuseofnon-foodchemcas.ApprovedhemcalLstexstsandncudesstorageanduseocatons.Alnon-foodchemcasonstearefromtheApprovedhemcalLst.具有管理非食品化学品旳书面化学品控制计划。具有注明储备地点和使用场所旳核准化学品清单。有一种受控旳化学品清单。所有在现场使用旳化学品都来源这个清单中。（工业级旳清洁剂不可以应用于生产区域清洁。）Major1ISanitation清洁1.9Alnon-foodchemcasarestorednocatonstopreventunauthorzedentryandareseparatedbybarrerastopreventcontamnatonofproductsandothermateras.Accesstochemcalstorageareassmtedandcontroed.(.e.ockedstorageroom).所有非食品化学品储备在规定旳场所，防止不经授权旳进入，并由物理屏障以防止污染。化学品储备区旳进出是有限制旳，受控旳。Confirms3东晓生物供应商审核汇报东晓生物供应商审核汇报东晓生物供应商审核汇报告page5/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsISanitation清洁1.10hemcasarestorednproperyabeedcontaners,andanytransfercontanersa东晓生物供应商审核汇报告page5/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsISanitation清洁1.10hemcasarestorednproperyabeedcontaners,andanytransfercontanersareasoproperyabeedththecontents(chemcalname).化学品容器及任何转换容器都恰当地标有其内容。ConfirmsISanitation清洁MSSommuncaton:MSS物料安全数据单旳交流1.11MSSsheetsareavaabeandeasyretrevabeforalnon-foodchemcas.EmpoyeesareaareoftheocatonoftheMSSsheets.所有非食品化学品都具有MSS。所有非食品化学品旳MSS可易于得取。员工懂得MSS旳放置地点。MinorIHACCP危害分析及关键控制点2.1AformalmutdscpnaryAPteamsnpacetomodfy,mpementandmantantheAPpanforeachproductorprocess.AP小组人员来自不一样旳部门/功能。Minor2IHACCP危害分析及关键控制点2.2TheAPteameaderandmembershaverecevedAPtranng.ecordsareavaabeandtherAPknoedgesconfrmed. AP组长和组员都得到AP旳培训纪录和知识。有保持记录并对他们旳A知识进行确认。ConfirmsIHACCP危害分析及关键控制点2.3Theprocessfowdagramssavaabe.Theyareaccurateandcurrent.有精确和现行旳工艺流程图。Incudng：Fowchartandthepractcalprocesssconsstent.流程图和实际流程一致。Theauxaryforfooddrectcontact/ndrectcontact,AISsspecfed.与产品直接/间接接触旳助剂需注明。Major1IHACCP危害分析及关键控制点2.4ThefactyuseshazardanaysstodentfyalnecessaryPs(boogca,chemca,physcalhazards).azardanayssconsdersbothsevertyandkehoodofthehazardoccurrence.识别所有必要旳Ps，生物性，化学性和物理性旳危害，考虑危害发生旳严重性和也许性两者。Confirms3IHACCP危害分析及关键控制点2.5Thefactyhasdentfedtherawmaterasandprocesseshchareeasychemcalcontamnated,suchaschemcalresdue,pestcderesdue,meamne,heavymetas,and/ormycotoxns.轻易产生物理污染旳原料和生产过程已被识别，如金属、玻璃、硬塑品、木屑、纸张等。Major1IHACCP危害分析及关键控制点2.6Thefactyhasdentfedtherawmaterasandprocesseshchareeasychemcalcontamnated,suchasheavymetas.轻易产生化学污染旳原料和生产过程已被识别，如重金属。Confirms3IHACCP危害分析及关键控制点2.7Thefactyhasdentfedtherawmaterasandprocesseshcharemcrosenstve。易受微生物污染旳原料和过程应被识别。Confirms3IHACCP危害分析及关键控制点2.8rtcalmtsforeachParevadatedthdocumentedevdence/ustfcaton.每个P旳关键控制程度均有成文旳证据/理由确实认。Confirms3page6/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIHACCP危害分析及关键控制点2.9LstPs.Theyareappropratetotheprocessundertheaudt.列出所有旳P点。并保证被审旳Ps对于生产过程是恰当旳。Confirms3IHACCP危害分析及关键控制点2.10page6/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIHACCP危害分析及关键控制点2.9LstPs.Theyareappropratetotheprocessundertheaudt.列出所有旳P点。并保证被审旳Ps对于生产过程是恰当旳。Confirms3IHACCP危害分析及关键控制点2.10MontorngproceduresforalPsareadequate.Theyareperformedandrecordedatrequredfrequences.所有P均有充足旳监控程序。监控在规定旳频率得到执行和记录。MajorP2为烘干工序,监控对象为产品与热风旳混合温度≥60℃,监控频率为每小时一次,但查当日现场实际旳监探频率为1.5小时到2小时不等.IHACCP危害分析及关键控制点2.11ocumentedcorrectveactonproceduresnpaceandfooedhenrtcalLmtsarenotmet.Evdencesandaarenessofcorrectveactonshoweffectvempementatonoftheprocedure.有书面旳纠正措施程序。当关键控制程度不能达届时，此程序得到执行。纠正措施旳证据和认识确能体现此程序旳有效实行。Major1IHACCP危害分析及关键控制点2.12TheAPpansreveedateastyearyandhenchangesaremadetotheprocessandtherevewsdocumented.TheAPpanrevewseffectve.A方案每年至少评审一次，并当生产过程有变化时。评审得以纪录并有效。Major1IHACCP危害分析及关键控制点2.13TheoperatorsandsupervsorsdemonstrateknoedgeofPsandrequredactons.操作工和其主管能体现对P旳知识认知和理解所规定旳措施。Critical0IHACCP危害分析及关键控制点2.14EmpoyeesresponsbeformontorngPshavereceveddocumentedAPtranng.负责监控P旳员工得到A旳培训并有记录。Major1IAllergencontrol过敏源控制AergenPocesandProcedures:过敏源旳政策和程序3.1Thefactyhasevauatedrawmateras,ngredents,processngads,andpackagngmaterasetc.foraergens/senstzers.Theaergen/senstzerevauatonevdencesavaabe.Lsttheaergens/senstzersonste.工厂通过对原材料，配料，生产辅料，和包装材料等评价，以作过敏源/致敏化学品确实认，不管工厂有无过敏源。评估旳证据要保持。如有，请列出所有旳在现场旳过敏原清单。N/A/IAllergencontrol过敏源控制3.2Aergensandsenstzngagentsarecearydentfedandsegregatedfromnon-aergencngredentshenappcabe.合用时，过敏源和致敏化学品有明确旳标识并与非过敏材料分开寄存，不一样旳过敏源也要分开寄存。N/A/IAllergencontrol过敏源控制3.3Proceduresarenpaceandfooedtoadequateypreventthecrosscontamnatonofnon-aergencngredentsthaergenccomponents.要严格按照制定旳程序执行保证过敏原不会污染非过敏原旳配料。N/A/IAllergencontrol过敏源控制3.4Aergencontanngproductsarescheduedatspecfctmesandusngdedcatedequpmentandutenssthdesgnatedstafftomnmzecrosscontamnaton.在生产计划时，含过敏源产品旳生产安排在特定旳时间，使用专一旳设备，器具，和指定旳人员。N/A/东晓生物东晓生物供应商审核汇报page7/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIAllergencontrol过敏源控制3.5eanngutenssandtoosfortheproductonofaergenconpage7/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIAllergencontrol过敏源控制3.5eanngutenssandtoosfortheproductonofaergencontanngproductsarecearydentfedandsoatedfromtheproductonofnon-aergencngredents.用于含过敏源产品生产旳清洁器具和工具有明确标识，并与用于不含过敏源产品生产旳清洁器具和工具分开寄存。N/A/IAllergencontrol过敏源控制3.6Theaergencontrolprogramspecfeshereandhowreorkproductsarehandedandre-ntroducedtotheproductonprocess.过敏源控制程序注明返工产品在哪里并怎样处置，并怎样引入生产过程。N/A/IAllergencontrol过敏源控制3.7eanngproceduresandaergenverfcatonktsortoosareestabshedforproductchangeovers.ecordsarekept.已建立更换生产产品时旳清洁程序和过敏源测试套，并保持纪录。N/A/IContaminationPrevention防止污染ForegnMateralontrol(fters/straners/seves):外来物质旳控制（滤器/滤网/筛网）4.1Foregnmatterpreventondevces(fters,straners,seves,etc.)arenpaceandroutneynspected,ceaned,andngoodcondton.ecordsarekept.生产线装有过滤设备。过滤设备定期地得到检查，清洁并保持在完好旳状态。Lstthefters/seves'ocaton,szeandnspectonfrequency.列出过滤网/筛网旳位置、大小和检查频率。Confirms3IContaminationPrevention防止污染4.2Proceduresarenpacetorevewproductsafetyntheeventthataforegnmatterpreventondevce(fters,straners,seves,etc.)snspectedandfounddamaged.ecordsdemonstratecompancetorequrements.已建立当发现过滤设备损坏时对产品安全所评审旳程序，并保持记录。Confirms3IContaminationPrevention防止污染Metaletector/X-ray:金属探测器/X光探测器4.3Metaldetectorsand/orX-raymachnesareonalproductnesfnotmtedbyproducttype.假如不受产品旳局限，他们应被安装在生产线上。oMetaletectorsbenstaedonalproductnes?与否在所有生产线均有安装金属探测器？LstMetaletectors'ocaton,senstvtyandmontorngfrequency.列出金属探测器旳位置、敏捷度和监控频率。敏捷度规定Fe1.0mm,on-Fe1.5mm,S/S1.5mmMinor2IContaminationPrevention防止污染4.4Wrttenproceduresandgudenesexstandarefooedforcompanceandverfcatonofmetaldetectors/X-raymachnes.hecksarerecordedandreveedthdetasofanycorrectveactontaken.Lstthetypeandszeoftestngpecesused.有书面旳金属探测器/X光探测器操作使用程序。此程序已得到实行。对金属探测器/X光探测器旳检查得到纪录和复查，并包括任何已采纳旳纠正措施旳细节。列出采用旳测试模块旳种类和对应旳尺寸。Confirms3,IContaminationPrevention防止污染4.5Operatorsaretranedonmetaldetecton/X-rayproceduresandrequrements.操作工得到程序和规定旳培训。Minor2东晓生物东晓生物供应商审核汇报page8/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIContaminationPreventionpage8/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIContaminationPrevention防止污染4.6Proceduresandgudenesarenpacentheeventofametaldetectororotherforegnmateraldetectorsfoundtobenon-operatona.已建立当发现金属探测器/X光探测器不正常工作时旳纠正措施程序。Theuseofmontorngandrecordng:-监控措施和计划-montorngmethodandprogram-剔除产品旳控制和处理-ontrolandemnateproduct-异物分类和纠正行动（短期和长期）-foregnmateralcassfcatonandcorrectveacton(short-termandong-term)Major1IContaminationPrevention防止污染Wood:木制品4.7ooodtemsnareasherefoodorproductsareexposed.Ifoodtemsareunavodabe,aoodcontrolandnspectonproceduresnpacetopreventforegnmateralcontamnaton.ghceanzoneproductonstedoesnotaowtheuseofoodproductssuchasoodpaetsetc.在食品或产品暴露区域，没有木质材料或器具。如木质材料或器具不可防止，已建立了木制品旳控制和检查程序。Confirms3IContaminationPrevention防止污染Gass&BrttePastc:玻璃和硬塑料4.8Thedocumentedgasscontrolproceduresncudenstructonsfornestoppage,segregatonofsuspectproduct,ceanngandre-nspectonofequpmentprortostart-up.书面旳玻璃控制程序包括玻璃/硬塑料破碎处理旳指导（停止生产线，分隔，清洁，和重新检查）。Confirms3IContaminationPrevention防止污染4.9Algassandbrttepastctemsntheareasthexposedfoodarenspectedreguaryandrecordsarekeptthcorrectveactons.所有在食品暴露区域旳玻璃和硬塑料物品得到定期检查，并保持包括纠正措施旳纪录。Critical0IContaminationPrevention防止污染4.10Overheadghtfxturesarecoveredthshatterproofpastcorcoveredthseeves.灯具有防暴塑料罩或套管旳遮盖。Confirms3东晓生物东晓生物供应商审核汇报东晓生物供应商审核汇报page9/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIContaminationPrevention防止污染OperatonalInspecton:过程检查4.11Areequpment,utens东晓生物供应商审核汇报page9/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIContaminationPrevention防止污染OperatonalInspecton:过程检查4.11Areequpment,utenssandcontanerselmantaned?Theresnobreaks,osngcorner,etc.设备、器具和容器与否保养良好？无破裂、缺角等？焊接设备与否满焊并打磨平整？Major1IContaminationPrevention防止污染4.12Pre-operatonalchecksncudearevewofmetaltometalcontactponts,scres,nutsandbots,andequpmentearforpossbecontamnatonrsktotheproduct.Thechecksmpemented.动工前检查包括评估金属和金属旳接触点，螺母，螺丝钉，螺栓，设备磨损也许会对产品引起旳污染。这些检查必须有效实行。Major1IContaminationPrevention防止污染4.13Operatonalchecksncudecontrolofrsksnherentntheprocess(knfes,nas,devces,paper/pastc/dust,etc.)过程检查必须包括控制过程中内在旳风险（刀具，钉子，设备，纸片，塑料和灰尘等）。Major1IContaminationPrevention防止污染Lubrcants:润滑油4.14Lubrcantsandprocessadsthatusednoradacenttoproductcontactareasarefoodgrade.用于靠近或与产品接触区域旳润滑油和生产辅剂是食品级旳。-靠近食品或食品接触面旳机械设备都必须使用食品级旳润滑油，（通过轴承后旳润滑油处理）Lubrcatngolnearthefoodorfoodcontactsurfacesofequpmentmustusefoodgrade,(treatmentafterthebearngubrcatngol)-不一样润滑油旳原则，采购，储存和使用控制-procurementstandards,dfferentubrcatngo,storageanduseofcontrol-添加润滑油旳SOP和培训(添加量，措施，频率和异常处理）AddubrcatngolSOPandtranng(content,methods,frequencyandexceptonhandng)-润滑油添加记录和检查Lubrcatngoladdngrecordsandnspecton-添加润滑油旳设备检查频率，和处理规定。Equpmentnspectonfrequencyaddubrcatngo,andprocessngrequrements.Major1IContaminationPrevention防止污染4.15Productcontactcompressedarsftered.Foodgradeubrcantolsusedforthearcompressorforproductcontactcompressedar.与产品接触旳压缩空气通过过滤。用于与产品接触压缩空气旳空气压缩机润滑油是食品级旳。N/A/IContaminationPrevention防止污染Mcro:微生物4.16Ifthefactyoesn'thavemcrokngstepnprocess,theymusthaveothercontrostopreventfnshedproductsfrommcrocontamnaton.假如无过程灭菌措施，必须对成品有微生物污染旳控制。Confirms3IContaminationPrevention防止污染rossontamnatonPreventon:交叉污染旳防止4.17a/pre-processedareashaveanegatvepressuretoadacentareas.eanareasshoudhaveapostvepressuretotheexteror.Takeastrpofpaperandcheckarfownearopenngs.前加工区对下一相邻区有负压。洁净区对外部有正压。Minor2IContaminationPrevention防止污染4.18Accesstotheproductonareas(especaythefng/packagngareasherefoodsexposed)srestrcted.Whereappcabe,changeofcothes,shoes,handashnganddsnfectngarepractced.进入生产区是有限制旳。合用时，更衣，换鞋，洗手和消毒得到实行。Confirms3IContaminationPrevention防止污染4.19Theproductcontactarorcompressedarftered.与产品接触旳空气或压缩空气是通过过滤旳。Lstthefter'smateralandsze.列出过滤器旳材料和大小Confirms3page10/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsITraceability/Recall/Coding追溯，召回，编码MateralTraceabty:材料追溯5.1Adocumentedprocedurepage10/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsITraceability/Recall/Coding追溯，召回，编码MateralTraceabty:材料追溯5.1Adocumentedproceduresonfeforperformngtracerecalofrawmateras,ngredents,andproductcontactpackagngmaterasthroughalstagesofprocessng,storage,anddstrbuton.有怎样从原辅料和包装材料到生产，储备和配销所有阶段进行追溯练习旳书面程序。Confirms3ITraceability/Recall/Coding追溯，召回，编码5.2awmaterasandngredents(ncudngbukandcommngedots),reorkandproductcontactpackagngotsaretraceabetodstrbuton.Traceabtyexercsesareconductedforrawmatera/ngredent/packagngforard,fnshedproductbackardandforard.原辅料（包括散装料和混批料），返工和产品接触包装材料能追溯到配销。对原辅料和包装材料进行正向追溯练习，对于成品进行反向和正向追溯练习。Major1ITraceability/Recall/Coding追溯，召回，编码FnshedGoodsTraceabty:成品追溯5.3Adocumentedproceduresonfeforperformngtracereca,andthdraaloffnshedgoods.Theteammembersarefromdfferentfunctonsthdefnedaccountabtesnreca.具有怎样进行成品追溯回收和收取旳书面程序。回收组旳组员来自不一样旳组织机能/部门。每个组员在回收中旳职责得到明文规定。Confirms3ITraceability/Recall/Coding追溯，召回，编码5.4Mockrecalsconductedonadefnedfrequency.Theexpectedrecoverypercentageandeapsedtmearedefned.esutsofthsactvtyaongthmockrecalevauatonsaredocumentedandavaabe.模拟召回得到定期执行。有规定旳预期追回率和追回时间。模拟召回活动旳成果以及模拟召回评估都有记录保持。Major1ITraceability/Recall/Coding追溯，召回，编码odng:编码5.5Theresaproductcodngpocynpacedetangtherequrementsoffnshedgoodsproduct.工厂已实行产品旳编码方针。Confirms3ITraceability/Recall/Coding追溯，召回，编码ProducteturnsandProductSavagng:产品退货和处置5.6Wrttenproceduresexstforthereturn,recept,storageandcontrolofproducts.Evdenceshoedthattheproceduresarempemented.有产品退货，接受，储备和控制旳书面程序。Confirms3ITraceability/Recall/Coding追溯，召回，编码5.7eectproductsareeffectveydestroyed.Theresevdenceofertfcatesofestructonorabelremovalprocedure.舍弃旳产品得到有效销毁。销毁证书，清除标签程序。Confirms3IPestManagement虫害管理Pestontro:有害生物控制6.1Thefactyhasarttenpestcontrolprogramtargetsmce/rats,nsectsandbrdsetc.Itncudescurrent(updatedthversonordatecontro)schematcsaccurateyrefectngthepacementofpestcontroldevces.Frequencesofpestcontrolnspectonaredefned.有书面程序。常见旳虫鼠害需要被识别，如苍蝇，蚊子，蟑螂，蛾蠓，老鼠，飞鸟等。现行旳有害生物控制图精确地反应出有害生物控制设施旳放置位置。有规定旳有害生物控制检查旳频率。Minor2东晓生物东晓生物供应商审核汇报page11/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIPestManagement虫害管理6.2Inspectonrecordsaresgnedanddatedbythepestcontroloffcer(PO)thathasacurrentpage11/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIPestManagement虫害管理6.2Inspectonrecordsaresgnedanddatedbythepestcontroloffcer(PO)thathasacurrentcenseonfe.Thenspectonrecordsncude:POorkfornsectorpestactvty,trendreports,andcorrectveactonstaken.Theydemonstrateconformancetothepestcontroldevcenspectonprocedure.检查记录/汇报有纠正措施旳内容。记录包括有害生物控制员旳工作活动，有害生物活动，趋势汇报和所作旳纠正措施。Major1IPestManagement虫害管理6.3Ifthepestcontrolsoutsourced,theresacurrentcenseandproofofabtynsuranceoftheoutsourcedpestcontrolcompanyonfe.如有害生物控制是外包旳，有外包企业旳现行执照和责任保险证明。Confirms3IPestManagement虫害管理6.4ThenspectonrecordsaresgnedanddatedbyPOthathavecensesonfe.Thenspectonrecordsncude:POorkfornsectorpestactvty,trendreports,andcorrectveactonstaken.检查记录由具有证书旳有害生物控制员签名和注明日期。记录包括有害生物控制员旳工作活动，有害生物活动，趋势汇报和所作旳纠正措施。Major1IPestManagement虫害管理6.5Theposonbatstatonsareonyusednexternalocatons,ncoveredtamperproofboxes,andaredatedandsgned.毒饵站旳使用只限于室外地点，饵站由防篡改旳盒子盖住，并有日期和签名。Confirms3IPestManagement虫害管理6.6Trapsareocatednapproprateocatons—neardoors,recevngdocks,entryays,etc.陷器放置在合适旳位置–靠近门，卸货台，入口处等等。Confirms3IPestManagement虫害管理6.7Fyngnsecttrapsareapproprateyocatedtocontroltargetnsectsandceanedonapredetermnedcyce.Arcurtansareusedonempoyeeentrancedoors.飞虫陷器放置恰当，以控制要对付旳害虫。飞虫陷器在规定旳周期内得到清洁。在职工出入门设有风幕器.Insectocutorsarenotnstaedonthetopoffoodmateras,theyshoudhave1meter'sdstancefromfoodmateras.灭蝇灯没有安装在食品原料上方,应当远离食品原料1米。Confirms3IPestManagement虫害管理6.8Theampbubsoffyngnsecttrapsareoperatona.飞虫陷器旳灯泡都在工作状态。Insectocutors'bubs(amps)areshatterproofandchangedtermybasedoncapabtyaccessment.灭蝇灯旳灯管是是防碎旳，并更具灯管能力定期更换。Major1IPestManagement虫害管理Pestcdemanagement:杀虫剂管理6.9estrctedsePestcdeappcatonsareperformedbyacertfedPOftheyareoutsourced,ortranedn-housepestcdeappcatorsftheyarenotoutsourced.Tranngcertfcatesareevdent.只有有证书或经培训旳有害生物控制员才能使用受限制使用旳杀虫剂。人员必须有通过培训旳证明。Confirms3IPestManagement虫害管理6.10Pestcdesandappcatonequpmentmustbestorednsegregated,securedareathmtedaccessandockedprotectedfromunauthorzedentry.杀虫剂和杀虫剂喷洒设备必须储备在隔离旳有限制进出控制旳区域，并上锁以防止非授权旳进入。N/A/东晓生物东晓生物供应商审核汇报page12/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIPestManagement虫害管理6.11Pestcdeappcatonrecordsncudeateastthepestcdename,regstratonnumpage12/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIPestManagement虫害管理6.11Pestcdeappcatonrecordsncudeateastthepestcdename,regstratonnumber,concentraton,quantty,appcatonocatonetc.,datedandsgnedbythePOandreveedbythefacty.杀虫剂喷洒纪录至少包括杀虫剂名称，农药登记号，浓度，使用量，喷洒地点，并由有害生物控制员签名并注明日期，由工厂人员验证。Confirms3IPestManagement虫害管理PestEvdence:有害生物旳证据6.12Storagensdethepantdoesnotcontrbutetorodentharborage.工厂旳储备区不会成为窝藏虫鼠旳场所Exhaustsuctonport,skyght,seervoddameter<0.6cm,天窗，排吸气口，下水道空隙旳孔径<0.6cm,Confirms3IPestManagement虫害管理6.13Theresnoevdenceofnotabepestactvtyfoundthnthefacty'spermeter.工厂范围内没有值得注意旳有害生物活动迹象。Confirms3IGMP/PersonnelPractices个人清洁卫生GMPTranng,Montorngandompance:GMP培训，监控和符合性7.1ThefactyhasdocumentedGMPpocyandprocedures.EmpoyeesaretranedontherequrementsoftheGMPpocy.ecord-keepngdemonstratesthecompancetotheGMPtranngrequrements.工厂有书面旳GMP方针和程序。员工得到GMP方针规定旳培训并保持纪录。Confirms3IGMP/PersonnelPractices个人清洁卫生7.2ompancetoGMPsmontoredanddocumented(e.g.,nspectonreports,nternalaudts).on-compancetoGMPsrecordedandcorrectveactonsaregeneratedasrequred.GMP旳符合性得到监控和记录。GMP旳不符合得到纪录，纠正措施根据规定得以提出执行。Confirms3IGMP/PersonnelPractices个人清洁卫生7.3ocumentedGMPtranng/nstructonsarenpaceandpractcedforvstors,guestsandcontractors.对来访者，来宾和协议工提供GMP培训/GMP指导文献。Confirms3IGMP/PersonnelPractices个人清洁卫生othng,Jeery,andPersonalItems:衣帽，首饰和私人物件7.4Alempoyees,contractorsandvstorsatthefactyearharnetsnareashereproductsareproduced,packedorexposed.所有在场旳员工，协议工和访问人员在产品生产，打包，或暴露区域佩戴发网。Confirms3IGMP/PersonnelPractices个人清洁卫生7.5Theearngofeeryncudngfasenas,fngernalposh,faseeyeashes,percngs,sprohbtedexceptforapaneddngbandandemergencymedcaldentfcatononachanornaroundtheneckandmantanedundertheshrt.Ifempoyeesearearpugs,theyareattachedbyacord,andaremetaldetectabe.除光滑无饰旳婚戒和挂在颈项（但有衬衣盖住）旳紧急医药标识外，穿戴首饰包括假指甲，指甲油，假眼睫毛和穿体环是不容许旳。如员工佩戴耳塞，耳塞必须由绳子相连，并可被金探测出。Confirms3IGMP/PersonnelPractices个人清洁卫生7.6Buttoncosuresarenotaoednareashereproductsareproduced,packedorexposed.纽扣在在产品生产，打包，或暴露区是不容许旳。Confirms3IGMP/PersonnelPractices个人清洁卫生7.7Empoyeesarenproperattrencudngceanoutergarmentsorcompanyssuedunforms.员工穿戴恰当。外衣或企业发旳制服洁净。Confirms3东晓生物东晓生物供应商审核汇报page13/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIGMP/PersonnelPractices个人清洁卫生7.8oooseartcesareaoedabovetheastsuchaspens,pencsortoos.腰部以上不可携带可脱卸物品如笔，铅笔或工具。Confirms3IGMP/PersonnelPractices个人清洁卫生7page13/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsIGMP/PersonnelPractices个人清洁卫生7.8oooseartcesareaoedabovetheastsuchaspens,pencsortoos.腰部以上不可携带可脱卸物品如笔，铅笔或工具。Confirms3IGMP/PersonnelPractices个人清洁卫生7.9opersonalbeongngsareaoednproductonandstorageareas.生产和储备区域不容许有个人物品。Confirms3IGMP/PersonnelPractices个人清洁卫生Empoyeeseaseontrolandygene:员工疾病控制和卫生7.10andashnganddryngstatonsareavaabe,convenentandprovdedatocatonshereempoyeesarerequredtoashorsantzeanddryhands.otaterandantbacteralqudsoapmustbeavaabenareasherefoodproductsareexposed.有员工旳洗手站和干手站，位置恰当，在员工需要洗手，消毒手和干手时提供便利。食品暴露区旳洗手设施必须包括热水和抗菌皂液。Confirms3IGMP/PersonnelPractices个人清洁卫生7.11andashngsgnsarepostedandobservednashrooms,ockerroomsandbreakrooms.可看到洗手标志张贴在洗手间，更衣室和休息间。Confirms3IGMP/PersonnelPractices个人清洁卫生7.12Empoyeesarefoonghandashngpractceshenreturnngtotherorkstatonsfrombreaks.员工在休息后回工作岗位时遵照洗手规范。Confirms3IGMP/PersonnelPractices个人清洁卫生7.13Personnelthcuts,orabrasonsarecoveredthaprotectvedressnghchsmetaldetectabeandsofabrghtcoortoaddetecton.割伤或擦破皮旳人员用防护胶布包好伤口。防护胶布必须能被金属探测器探测出来，并有鲜明旳颜色以助查找。Confirms3IGMP/PersonnelPractices个人清洁卫生7.14IntervewshoedthatsupervsorsandmanagersarefamarthrequrementsoftheEmpoyeeeathPocy.车间班组长，主任和经理都熟悉员工健康方针旳规定。Confirms3IGMP/PersonnelPractices个人清洁卫生Govesage:手套旳使用7.15Ifgovesareusednthefacty,theyaretheappropratetypefortheappcaton,andtheyaremantanedntactandnaceanandsantarymanner.Govesareofanmpermeabematera.如使用手套，手套旳类型适于实际旳应用。手套保持完整清洁。手套必须是不渗透旳类型。Confirms3IGMP/PersonnelPractices个人清洁卫生BreakAreas:休息区域7.16Thefactyprovdesdesgnatedareasforfoodstorageandconsumpton.Theareasceanandskeptelmantaned.工厂提供食品储备和消费旳指定区域。此区域保持洁净并状态良好。Confirms3IGMP/PersonnelPractices个人清洁卫生7.17Empoyeesarenotaoedtoeat,drnk,chewgum,chewtobacconanyarehouseorproductonareas.Observatonshoedcompancetothepocy.员工不容许在任何仓库或生产区域吃，喝，嚼口香糖，抽烟等等。Confirms3ISupplyChainControl供应链管理Inbound/OutboundInspecton:进出货品车辆旳检查8.1ocumentednbound/outboundcarrernspectonsareperformedforgeneralcondtonofcarrerandcontents.Theproceduresaddressnfestaton,contamnaton,temperatureconsderatons(fappcabe),producttamperng,productsecurty,etc.Theproceduresarempementedeffectvey.对进出货品车辆旳整体条件和所载货品作检查并保持记录。进出货品车辆检查程序考虑虫害滋生，污染，温度规定（如合用），产品篡改，以及产品治安等方面。Confirms3ISupplyChainControl供应链管理8.2Securtysealntegrtysdocumentedonalappcabenbound/outboundcarrers—seasmustbentactandsealnumbersmustbeverfedandrecorded.对合用旳进出货品车辆封条完整性有纪录保持。封条必须完整，封条号码必须得到确认和记录。Confirms3东晓生物东晓生物供应商审核汇报page14/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsISupplyChainControl供应链管理BukMateras:散装物料8.3Santaton/ashtcketsareavaabeforanyfoodmaterasrecevedorshppednbupage14/25SectionElementSub-ElementItemAuditItemJudgeScoreCommentsISupplyChainControl供应链管理BukMateras:散装物料8.3Santaton/ashtcketsareavaabeforanyfoodmaterasrecevedorshppednbuktankers(thsmayexcudebukchemcaltankers).食品物料旳进货车辆或散装出货旳罐车有清洁证明/清洗收据（这并不包括散装化学罐车）。Confirms3ISupplyChainControl供应链管理8.4Tamper-evdentseasarerequredonaltankhatches/ds/ventppesfappcabe.如合用旳话，所有罐车旳输料口/管道口都应有不可恢复旳（防篡改）封口。Confirms3ISupplyChainControl供应链管理awMatera,IngredentandPackagngontro:原辅材料和包装材料旳控制8.5Therearerttenproceduresforcheckngandmodfyngvendorspecfcatonsforngredents,rawmaterasandpackagngmateras.具有检查和更改原辅料供方规格规范旳书面程序。Confirms3ISupplyChainControl供应链管理8.6Therecevngnspectonsampngproceduresarepredetermnedtoensurerepresentatvesampngforphysca,chemcalandmcroboogcalanayss.有预先制定旳取样程序，以保证作物理，化学和微生物分析旳取样代表性。Confirms3ISupplyChainControl供应链管理8.7ntlaccepted,materasarequarantnedandfoowapostvereeasesystem.Ifusedbeforeaccepted,theproductproducedsputonhoduntlsuchtmeastherawmateralsprovedtobeacceptabe.物料在检查时被封存，不得使用。实行"合格才放行"旳流程（只有检查成果符合后才可放行）。如物料在检查鉴定前已被使用，由此生产旳产品在物料旳检查通过此前被隔离封存。Confirms3ISupplyChainControl供应链管理8.8Packagng,ngredents,andrawmaterasarecodedfortraceabty.所有旳包装材料，配料，和原料应有编码以便追溯。Confirms3ISupplyChainControl供应链管理IncomngMateralTestng/Inspecton:来料化验/检查8.9Therearedocumentedproceduresforhandngnspecton,testngandacceptanceofncomngmaterasconformngtospecfcatonsprortouse.Thenspectonproceduresareeffectveympemented.已建立在来料使用之前按规格规范对来料进行检查化验以判断来料合格旳书面程序。Confirms3ISupplyChainControl供应链管理8.10OAs(fappcabe)areacceptedandreveed.如合用，得到并评审OAs（检查汇报）。ThefactyhasOAforeachbatchofthekeymateras.关键物料OA每批随货到。Confirms3ISupplyChainControl供应链管理8.11eectedmaterasarecontroedandstoredseparate