验厂标准 麦德龙.docx
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验厂标准 麦德龙.docx
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验厂标准麦德龙
SupplierName(供应商)
SupplierCode(供应商编码)
FactoryName(工厂)
FactoryAddress(工厂地址)
FactorySiteInformation(工厂信息)
Ownership(private,public,belongingtogroup)
所有关系(私营、集体所有、归属于集团)
Yearofestablishment
(incurrentlegaldocument)
成立时间(以最近的法律文件为准)
OrganizationChartofFactory
工厂组织结构
ProductsManufactured
(产品)
ProductsforMGB
(生产的MGB产品)
ProductionCapacity
(monthly/annualQty)
产能(月产量)
ManufacturingPremises
(SqM/SqFt)
生产场地(平方米/平方英尺)
Machine/Equipmentused
(no.ofunits)
使用的机器设备(每款数量)
EmployeesDetails(no.ofpeople)员工信息(员工数量)
Supervisors/Managers
(管理者/经理)
Administration
(行政人员)
QualityControl
(品管)
Engineering
(技术人员)
Design&Development
(研发人员)
PermanentWorkers
(固定员工人数)
TemporaryWorkers
(流动员工)
GrandTotal(总计)
WorkingHour(howmanyshift,fromwhentowhen?
)
工作时间(几班,具体从几点到几点)
No.ofsubcontractorsused
(转包商数量)
Name&processofmainsubcontractors
)主要转包商的名字及具体工作)
无
Section1:
GeneralOrganizationStructure
Item
Question
Result
Remark
Yes
No
N/A
1.1
Doesthefactoryhavetheuptodateorganizationalchart?
Ifyes,pleaseattachacopyoforganizationchart.
是否有最新的组织结构图?
如有,请提供一份组织结构图。
1.2
Arethereappropriatearrangementsincaseofabsenceofkeystaffs?
Arethereanysupportingdocumentorrecord?
主要人员不在时是否有替代安排?
有何种支持性的文件或记录?
1.3
Doesthefactoryhavethedefinitionofresponsibility&accountabilityforkeystaffsinvolvedwithactivitiesimpactingproductsafety,legalityandquality?
对于负责产品安全性、合法性和质量的主要人员,是否有规定的职责和权限?
Section2:
GeneralFacilityManagement
Item
Question
Result
Remark
Yes
No
N/A
2.1
Isthefactorysitebeingmaintainedtominimizepotentialforproductcontaminationanddamage?
厂房是否维护良好,避免产品被污染或损害?
2.2
Doesthefactoryfreeofanyprocessrunningoutside/outdoorsoronlywithasunshade?
是否没有工序或操作在室外或只在有顶棚的外部区域进行?
2.3
Doesthefactoryhavetheprocessflowdiagram?
Ifyes,pleaseattachacopyofflowdiagram.
是否有工序流程图?
如是,请提供流程图复印件。
2.4
Doesthefactorysiteallowsufficientworkingspaceandstoragecapacitytoenablealloperationstobeconductedundersafeandnecessaryhygienicconditions?
是否有足够的作业及储存空间,使生产处于安全和卫生的条件下进行?
2.5
Doesthefactoryeffectivelysegregaterawmaterial,workinprogress,rework,packagingandfinishedproductstominimizetheriskofcross-contamination?
是否对原材料、半成品、返工产品、包装材料及成品等进行有效隔离,防止交叉污染?
2.6
Areallmachineandequipmentadequatelymaintainedandoperatedtoproductsafety,qualityandlegality?
Aretheremaintenanceplanandrecordsavailable?
所有的设备是否维护良好,以满足产品安全,合法性及质量的要求?
是否有设备保养计划和记录?
2.7
Arecleaningandpestcontrolchemicalssuitablyidentified,labelled,controlledandadequatelystoredtopreventriskofproductsafety,qualityandlegality?
用于清洁和灭虫的化学品是否适当标识,控制和储存,以免影响到产品的安全,质量和合法性?
2.8
Aredocumentedcleaningproceduresavailable(bothin-houseandoutsourced)andmaintainedforthefactorysite,utilities,plantsandallequipment?
Followinginformationshouldbeincluded
responsiblepersonforcleaning
item/areatobecleaned
frequencyofcleaning
methodofcleaning
cleaningmaterialstobeused
cleaningrecordsandresponsiblepersonforverification
revalidationprocedure
对于厂区(内外部),公共设施及设备是否有书面的清洁程序,内容包括:
负责人;清洁区域,范围;清洁频次;清洁方式;使用的清洁工具;清洁记录和验证人;消毒和清洁程序的再确认。
2.9
Arecleaning,sanitationandhousekeepingcarriedoutbytrainedpersonnelinaccordancewithprocedures,effectiveness,correctiveactionsverifiedanddocumentedandrecordsmaintained?
清洁消毒等是否由经过培训的人员实施,是否有相应的清洁记录和必要的验证及纠正措施记录?
2.10
Isthereanylicenseorregistryrequiredfromtheappropriategovernmentagency?
Ifyes,pleaseattachacopyoflicenseorregistry.
是否有获得适当政府机构所发出的营业执照?
如是,请提供营业执照的复印件。
Section3:
QualityManagementSystems
Item
Question
Result
Remark
Yes
No
N/A
3.1
IsthisanISO9000accreditedfactory?
Ifso,pleaseattachacopyofcertification.
是否获得ISO9000质量体系认证?
如是,请提供质量体系认证证书复印件。
3.2
Doesthequalitymanagementsystemincludequalitypolicy,measurablequalityobjectives,qualitymanual,productsafety,procedureandworkinstructionsandreviewedatleastannually?
质量管理体系是否包括质量方针,可测量的质量目标,质量手册,产品安全性,程序文件,作业指导书及年度评审?
3.3
Isthereanadequatesystemforcontrollingcustomerrequirement?
是否有足够的系统来控制顾客的要求?
3.4
Doesthefactoryestablishspecificationsforrawmaterials,components,andbought-inpartsincludingpackaging,intermediate/semi-processedandanyproductorservicewhichcouldimpacttheintegrityofthefinishproduct?
对于所有影响最终产品的原材料,零部件,包材,半成品等,是否建立相关的规格要求?
3.5
Doesthefactoryhaveclearlyproductspecifications?
是否有成品规范?
*3.6
Arespecificationsaccurateandcomplyingtorelevantsafety,legislativeandcustomerrequirements?
规范是否正确并符合相关安全标准、法规及顾客要求?
3.7
Isthereanup-to-datesuppliers&sub-contractorslistandsuppliers/sub-contractorcontrolprocedureavailable?
是否有最新的合格供方(供应商,分包商)清单,及供应商/分包商的控制程序?
3.8
Arethereinternalauditprocedureandrecordsavailable?
是否有内审程序和记录?
3.9
Doesthefactoryhavedocumentcontrolprocedure?
是否有文件控制程序?
3.10
Doesthefactoryhaverecordcontrolprocedure?
是否有记录控制程序?
3.11
Doesthefactorydocumentallprocessandproductchanges?
过程和产品的变更,是否都保留记录?
3.12
DoesthefactoryhaveCAPAprocedure?
是否有纠正预防措施程序?
3.13
Arethemanagementreviewconductedatleastannually,documentedandincludetheevaluationofbelow?
Internal,customerandexternalaudits
Previousmanagementreviewdocuments,correctiveactionplansandtimeframes
Customerperformanceindicators,complaintsandfeedback
Incidents,nonconformingmaterialsandcorrectiveactions
Anassessmentofprocessperformance
Reviewoftheproductriskassessmentsystem
Reviewoftheresultsofmonitoringandtesting
Developmentsinlegalrequirementsorscientificinformationassociatedwiththeproductsinscope
Resourcerequirements
Improvementforthevalidityofqualitymanagementsystem
是否进行年度管理评审,记录包括:
1.内部的,第2或第3方的审核报告
2.以往的管理评审记录,纠正措施计划和时间表
3.客户业绩指标,投诉和反馈
4.事故,不合格品及纠正措施
5.过程业绩的评估
6.产品风险评估系统的评审
7.监控和测试结果的评审
8.与产品相关的法规要求或科技信息的开发和改进
9.资源需求
10.质量管理体系及其过程有效性的改进
3.14
Dofinishedproducts(includingre-work)haveafulltraceabilitytorawmaterialsourceandviceversa?
是否能从成品追溯到原材料,或反之亦然?
3.15
Doesthefactorytestthetraceabilitysystemtoensuretheeffectivenessofthesystem?
Isthefrequencyoftestconductatleastannually?
Resultsbeingretained?
Timetakentocompletethetestbeingmeasuredandrecorded?
对该追踪系统有效性的测试,是否至少每年做一次,是否保留结果?
是否测算并记录测试所需要的时间?
Section4:
Hazard&RiskManagementSystems
Item
Question
Result
Remark
Yes
No
N/A
4.1
Isthereadocumentedprocedureinplaceforchanginginproductdesign?
是否有订立文件程序来处理产品设计的更改?
4.2
Doesthefactorydefineandlistthelegalstatutesandmandatorystandardsapplicabletoeachproductandtothematerialsfromwhichitismade,relevantintheregionsofintendedsale?
是否列明所有与产品相关的符合销售国的法律法规和强制指令?
4.3
DoesthefactoryestablishaProductRiskAssessmentprocedureforeachproductoragroupofsimilarproducts?
是否对单个产品或产品组建立产品风险评估程序?
4.4
DoestheProductRiskAssessmentensurethefollowing?
Hazard/riskidentification
Risklevelforeachhazard/risk
Whethertheriskisacceptableconsideringtheprobabilityortheseverityandpotentialconsequencesoftheeffectsonconsumersafety
Thepersonresponsiblefortheassessment
Thedateperformedandtheevidence
NewProductRiskAssessmentforproductwithmodifieddesign(Theriskassessmentmaybeprovidedbyinternalorexternalresources)
产品风险评估记录是否包括:
风险识别;风险评级;是否考虑到对消费者安全影响的可能性,严重性和潜在性;评估负责人;评估日期,证据;对于设计更改的产品的重新评估?
4.5
Isriskassessmentconductedandverifiedbycompetentpersonnelpriortoproduction?
是否在生产前由有资质的人员进行风险评估和验证?
4.6
Istheriskassessmentregularlyandatleastannuallyreviewed(whiletheproductsarestillinproduction)takingaccountofcomplaintsorincidentswiththeproductorsimilargroupofproductsandreflectsanychangesinlegislation.
考虑到投诉或生产事故或法规的更改,是否进行至少每年一次的风险评估的评审?
*4.7
Doesthefactoryhavetestingresultsofarepresentativeproductfromaqualifiedandaccreditedlaboratory(internalorexternal)asasupportinginriskassessment?
是否有有资质的实验室(内部或第3方)提供的测试结果作为风险评估的依据?
*4.8
Doesthefactorydocumentandverifytheidentity,qualificationand/orlicenseofthepersonproducingthesafetyrevieworriskassessment?
是否记录及验证实施安全评审或风险评估的人员的身份、资格和执照?
Section5:
CompliancetoLawsandRegulations
Item
Question
Result
Remark
Yes
No
N/A
*5.1
Hasthefactoryasystemtoensureitiskeptinformedofchangestorelevantlegislation,productstandard,safety,industry/customercodesofpracticesrelevanttotheproductinscopeandregionsofintendedsale?
Ifyes,bywhichway?
是否建立获取最新法规,产品标准,安全性,行业标准的体系?
如果有,通过什么方式获取?
5.2
Isadocumentedprocessexistforincorporatingchangesinlegislation,standards,safetyetc,intothefactory’sprocedures?
是否有将相应的变更融入公司程序的书面程序?
5.3
Arethecopiesoflegislation,productstandard,productsafety,industrynormandcustomercodeofpracticesavailabletothestaff?
员工是否能随时查阅相关的法规,产品安全,行业规范及标准?
Section6:
Training&Competency
Item
Question
Result
Remark
Yes
No
N/A
6.1
Doesthefactoryensurethatallemployeesareabletodemonstratecompetencewithregardstotheiractivity?
identifytheneedfortraining
documenttrainingproceduresandrecordstodemonstratethattrainingiseffectiveandregularly
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