可口可乐供应商检查表Word文档格式.docx
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FDA注册号
AuditDate:
审核日期
Auditor（s）:
审核人员
Contacts:
联系人
Name名字
Title/jobposition职位
e-mail
ProductscurrentlymanufacturedforTheCoca-ColaCompany（TCCC）:
提供给可乐公司的产品
Name名称
SpecificationorRevisionNumber标准及代码
ShippingDestination（country）发运目的地
Ingredient原料
ShelfLife寿命
StorageConditions储存要求
EXPECTATIONS指标
AsFound
Auditor’sNotes发现问题
A:
QualitySystem质量体系
Supplierhasadocumentedqualitypolicy.
供应商有质量手册
Theeffectivenessofthequalitysystemisperiodicallyreviewedbymanagement.
管理层对质量体系的有效性进行定期评审
Thesupplierhasaneffectivedocumentmanagementsystem.（KeyPractices–seenotes）
供应商有有效的文件管理体系
B:
QualityPrograms质量程序
ConformancetoSpecifications标准的符合性
ThesupplierhasthemostcurrentspecificationsfromTheCoca-ColaCompany?
供应商是否有最近更新的可乐公司标准？
GoodManufacturingPracticesGMP
Thereisnotanyimproperlystoredequipment,litter,waste,refuse,uncutweedsorgrasswithintheimmediatevicinityoftheplantbuildingsorstructuresthatmayconstituteanattractant,breedingplaceorharborageforrodents,insectsandotherpests.
无不符合要求的储存：
垃圾、废品、未切割的种子或者草，适合昆虫繁殖和鼠类藏匿的场所
Thereisadequatedrainageinallareastopreventthecontaminationofcomponentsthroughseepageorfoot-bornefilth.
有足够的排水系统，防止污染
Floors,wallsandceilingsintheplantareofsuchconstructionastobeadequatelycleanedandarekeptcleanandingoodrepair.
厂区的地面、墙和天花板要保持清洁和维护
Fixtures,ductsandpipesthatdriporformcondensationarenotsuspendedoverworkingareaswhereapotentialofcontaminationmayoccur.
生产区域上方，设备、管路上的冷凝水、滴漏将是潜在的污染
Separationbypartition,locationorothereffectivemeansisprovidedforthoseoperationsthatmaycausecontaminationoffoodproductswithundesirablemicroorganisms,chemicals,filthorothermaterials.
将区域分隔是为了提供适宜生产的区域，以避免微生物、化学品、污物以及其它原料对食品的污染
Adequatelightingisprovidedtoallareaswheremerchandiseoringredientsareexamined,processed,orstoredandwhereequipmentandutensilsarecleaned.
产品和原料检查、加工、储存，设备和器具的清洁区域需提供足够的照明
Lightbulbs,fixtures,skylightsorotherglasssuspendedoveranyingredientorpackagingmaterialexposedinanystepoftheoperationareprotectedtopreventcontamination.
在原料和包装材料上方的灯具、天窗以及其他悬挂的玻璃制品，必须有防护
Adequateventilationorcontrolequipmentisprovidedtominimizeodorsandnoxiousfumesorvaporsinareaswheretheymaycontaminatecomponents
足够的换气设备使得异味、有害气体、蒸气降低到最少
Theplumbingusedthroughouttheplant（sewage,liquidwaste,andpotablewater）isdesignedsoastonotconstituteasourceofcontaminationofcreateanunsanitarycondition.
在厂区使用铅管（于用污水，饮用水）的设计，使之不成为一种污染源
Eachplantprovidestoiletfacilitiesthatareadequatelystocked,maintainedinasanitaryconditionandkeptingoodrepairatalltimes.Signsarepostedinstructingemployeestowashhandswithsoapbeforereturning
工厂内的厕所必须充足的，且应进行必要的清洁和维护。
洗手规程应张贴以提示员工在洗手前要擦肥皂
Adequatelystockedhandwashingstationsareprovidedateachlocationintheplantwheregoodsanitarypracticesrequireemployeetowashorsanitizeanddrytheirhands.
在需要清洗消毒的区域，必须提供足够的清洗设备（包括皂液、干手器）
PersonnelPractices:
Documentedclothingandsanitarypracticesareinplaceforallpersonnelhandlingorprocessingfood.
（KeyPractices–seenotes）
个人习惯：
食品生产和交付的区域，应规定人员的着装、清洁操作
GoodLaboratoryPracticesGLP
Testingfacilitiesandequipmentareadequateforthedegreeofaccuracyrequired.
（KeyPractices–seenotes）
-Alltestequipmentiscalibratedatregularintervals,andrecordsofthesecalibrationsarekept
测试设备的精度和量程要符合要求
所有测试仪器必须定期校正，校正记录需保存
Published,recognized,andvalidatedtestingmethodsareinuse.
采用经过验证确认并文件化的测试方法进行测试
Reagentsolutions,reactantsandstandardsarehandledproperly（duedates,normalization,etc.）
试剂溶液、反应物、标准的操作应符合规定（到期日、标准化等）
Allqualitytestingfollowswrittenstandardoperatingprocedures（SOP）.
所有测试方法应参照标准操作规范
Theaccept/rejectcriteriaandresponsibilitiesareclearlydefined
接受/拒绝的评估标准应定义清楚
Retainedfinalproductsamplespolicyandprocedure
成品的留样规定和程序
Whattestsdoesthesupplierperformforfinishedproduct?
厂商的成品检测项目是哪些？
WhichtestdoesthesupplierrecommendthattheConcentrateplantsperformintheirincominginspectionprogram?
哪些测试是厂商推荐且关键的？
Whichspecificationparameterdoesthesupplierconsiderisalowqualityriskone?
哪个质量指标是厂商认为低风险的？
SpecificationMonitoringgaps（testsnotperformed,materialspecification,etc.
测试监视方法的差异（测试方法，原料标准等）
PersonnelTraining人员培训
Aneffectiveemployeetrainingprogramisinplaceforcompanyandqualitypoliciesonhygiene,GMPs,HACCP/FoodSafety,sanitation,safety,andsecurity.
有效的人员培训规划：
质量方针、GMP、HACCP、食品安全、清洁消毒、安全和保安
Supplierhasatrainingprogramforcontractemployees（Providedefinitionforcontractemployees）.
厂商对合同工有培训规划，并对其有评估
PestControlProgram昆虫控制
Pestcontroliseffectiveandcarriedoutbycompetentpersonnel.
由胜任的人员执行有效的昆虫控制
Recordsandschedulesavailableindicateregularinspection,treatment,customerresponse,asappropriate,andsignedoffwhencompleted.
记录和日程表要显示：
定期的检查、处理、客户的反馈，结尾
Pesticidesareproperlysecuredwhenstoredonsite.
在储存区，杀虫剂得到有效防护
Allareasareaccessibleforinspection.Agapofatleast45cm（18in）ismaintainedaroundtheinsidebuildingperimeter.
对所有区域进行检查。
物品堆放距离墙45厘米
CleaningandSanitationControls清洁消毒
Thesupplierhasaneffectiveprogramformaintenanceofbuildingandgrounds?
厂商对建筑物和周边环境有有效地清洁消毒纲要。
Thesupplierhasadocumentedandeffectiveprogramforthecleaningandsanitationofworkareasandequipment?
厂商是否有文件化和有效的对生产区和设备的清洁消毒纲要？
Thereisasystemforverifyingtheeffectivenessofthesanitationprogramthatincludesmicrobialandallergencontrols.
有对清洁消毒的效果进行评估的程序，包括微生物和过敏反应
Equipmentisdesignedtobeeffectivelycleanedandsanitized.
设备的设计应便于设备的清洁消毒
Cleaningagentsareappropriateandclearlymarkedforuseinfoodareas;
storedinadesignated,secureplace,handrestrictedinuse.
清洁剂应是食品级，且标识清楚；
在指定的安全区域储存，领用须受控
Waterusedforsanitationintheplanthastheappropriatequalityforitsapplication.
厂內用于消毒的水质需符合质量要求
WarehouseandShippingContainers仓储、发运
Controlsareinplacetoensurethatwarehousesandshippingcontainersarecleanandwellmaintained?
保证仓储和发运干净、有效维护
Productsarestoredandhandledinamannertopreventdeterioration,damage,orcontamination?
产品的储存和交付要防止污染、损坏
Supplier’sproductsarenottransportedwithothergoodswhichcouldcontaminatetheproductbystrongodors,etc.?
厂商在交付产品过程中，不得与其他货物（有浓重的异味等）混放
Thesupplierhasaneffectiveprocessforsegregatingandtrackingrawmaterials,finishedproduct,productonhold,releasedandreworkedmaterials.
厂商有对原料、成品、隔离品和放行返工的原料的隔离、跟踪程序
Thesupplierhasaneffectivefinishedgoodsandrawmaterialinventorymanagementsystemandcanensurethatshipmentsareaccordingtospecificationsandrequirements.
厂商有成品和原料的储存管理程序，来保证发运符合标准要求
Thesupplierhasasysteminplacetopreventtheinadvertentshipmentofnon-conformingproductsoringredientstoTheCoca-ColaCompany.
厂商有防止不合格产品和原料因疏忽流向可乐公司的程序
FacilitiesandEquipmentDesign设备、工具的设计
BuildingsandGrounds:
建筑和周边环境
Facilitiesareofsuitablesize,design,andconstructiontofacilitatemaintenanceandsanitaryoperations.（KeyPractices–seenotes）
建筑设计便于维护清洁
Equipment:
设备
Doessupplierhaveanequipmentdesignapprovalpolicyorprocedures?
Notewhethertheprocedureincludesreviewofnewequipmentforsanitarydesignconsiderations.
厂商是否有用于设备设计的认可程序?
注意该程序是否将新设备的清洁设计包含其中?
Isthereanequipmentinstallationapprovalpolicy/procedure?
是否有设备的安装认可程序?
Isthereaprocedureforverifyingandchallengingsanitarydesignandinstallationofnewequipment?
是否有对设备的清洁、安装的评估程序？
EquipmentMaintenanceandCalibrationControls设备的维护和校正
SupplierhasaformalCalibrationprograminplacethatidentifiescriticalequipment,identifiesaccuracyandprecision,usesappropriatetraceablestandardsandmethods,andincludesappropriatecalibrationandcalibrationverificationfrequencies.
-Providedefinitionforcriticalequipment（equipmentthatcanaffectproductquality）
厂商有正式的设备校正计划：
设备的重要性、精确度、精密度、基准的追溯和方法、校正的频率
—对关键设备的定义（设备对产品质量的影响程度）
Isthereaneffectivemaintenanceprograminplacethatidentifiescriticalequipment,monitorsperformanceandschedulesroutinemaintenance?
是否有有效的设备维护程序，鉴别关键设备，监控其表现，制定维修保养日程？
RecordKeeping记录保存
Systemsareinplaceformanagingandcontrollingqualitysystemdataandrecords.
有管理控制质量体系的记录的系统
Recordsareaccurate,legibleandproperproceduresareutilizedformakingcorrections.
记录准确、清晰，并有对涂改方法的规定
CorrectiveandPreventiveAction纠正和预防措施
Facilityhasasystematicapproachorprogramforcorrectiveandpreventiveactionstoreacttoproblems,e.g.,non-conformances,complaints,auditdeviations
有系统对问题项、不符合项、投诉、审核发现的不符合项进行纠正和预防措施
Doestheprocessincludeidentificationofissue,investigationofrootcause,timelycorrectiveaction,andfollow-uptoconfirmimplementationandeffectiveness?
该过程是否包含问题的评估、根本原因的分析、纠正措施的时限、以及纠错
升级会员 