精品Supplier Audit Checklista.docx

精品Supplier Audit Checklista.docx

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精品SupplierAuditChecklista

GeneralInformation:

普通信息

Supplier’sName:

供应商名称

Addressofthesite:

地址

ParentOrganizationname:

母公司名称

Country:

国家

Phone:

电话

Fax:

传真

Website:

网址

FDARegistrationNo:

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.

（KeyPractices–seenotes）

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、以及纠错的有效性跟进？

C:

SupplierGuidingPrinciples厂商的指导政策

SupplierhasdesignatedresponsibilityfordealingwithEnvironmental,Health,andSafetyissues.

厂商应对环境、健康、安全进行有责任规划

Doesthesuppliersub-contractanyofthegoodsorservicesthatwebuy?

厂商是否有我司购买的产品和服务的合同？

Ifthesuppliersu