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1、YesDivNo34556)67889本模块作为审核指南,完成模块中内审的考核以确定被审公司是否符合可乐要求1)Questionnaire:1. Arepersonnelpracticesimplementedasrequired?人员习惯符合要求吗Doestheplantfollowthedesignrequirementsforpersonnelfacilities?2. 厂房设计符合人员设备要求吗Areappropriateprogramsinplaceforthehiringofpersonnel?对雇用人员有没有相关的程序。3. Istheaccesstothefacilitycon
2、trolled?进入设备区受控吗4. Istheplantprotectedagainstcontaminationfromoutside?厂房的设备能防范来自外界的污染吗Istheinterioroftheplantprotectedagainstspecificcontamination?厂房内部是无保护特殊的污染吗5. Iscontactair(compressedairusedforblowing,filling,CIP,pliantwithrequirements?接触的空气符合要求(用于吹瓶、灌注和CIP等压缩空气)6. IsthequalitylabaccordingtoGMPs
3、tandards?质量实验室符合GMP标准吗Isthedisposalanddestructionoftrademarkedmaterialshandledaccordingtotherequirements?是根据相关要求处理和破坏有商标的材料。7. Istheplantonlyusingapprovedcontactmaterials?8. 所用一级包装材料是经认可的吗Isanadequatehousekeepingprogramdevelopedandimplemented?制定和实施了厂房管理程序吗9. IsanadequatePestControlprogramimplemented
4、?实施了虫害控制吗。2)RefereneeStandardsList:BeverageOperationsManualBO-RQ-GoodManufacturingBO-RQ-Control&Distr.ofNon-conforming200Practices905TrademarkedMaterials&ProductsBO-RQ-BO-RQ-225PersonalPractices940SecurityBO-RQ-BO-RQ-950PestControl910PurchasingTCCQSupdatesarecapturedtillDecember15th,20053)Specificat
5、ionsandRequirementsSummary:Specifications/RequirementsPersonnelPractices1Arepersonnelpracticesimplementedasrequired?人员习惯符合要求吗Especiallyattheglasslines,theuseofsafetyapparelisimportantandmandatory.特别是玻璃线人员使用安全服是非常重要的并是强制性的BO-RQ-225* Applyhealthstandards:使用健康标准:- Employeesweareffectivehairrestraintsin
6、allprocessingareas(beardormoustacherestraintsarealsorecommended)-在加工区员工须戴有效的防洛发帽,(胡子也要求去除)- Openwoundsandinfectiousdiseasepoliciesinplace(nottoworkinrawmaterialhandling,processingareas,primarypackagehandling)-有对暴露的伤口和传染病的规定吗(不在原料处理区、工艺区、初级材料包装区工作。- Meetallapplicablehealthregulations-符合所有健康法规。 Includ
7、eadocumentedhygieneprogramincluding:文件化卫生程序包括:-Wash-Hands”policies-washwithgermicidalsoapandwater,rinsefullywithwateranddry(beforestartingtoworkinprocessingareaandaftereachabseneefromthearea)-洗手措施:-使用具有杀菌功效的肥皂,充分冲洗并干燥(在进入工作区之前,和每次离开工作区以后)- Nouseoffingernailvarnishorlacquer(uniessglovesareworn).Finge
8、rnailsareshortandclean(inprocessingareas)-不能留长指甲,不许涂指甲油,保持指甲清洁。- Foodordrinksonlyindesignatedareas.-食品和饮料在指定区域- Nodrinkcoolersorfood-vendingmachinesinprocessingareas-工乙区不能有饮水机和食品售买机- Noalcoholordrugsallowedintheplant.-在厂内不能有酒和药。- Smokingonlyallowedindesignatedareas-在指定区域抽烟* Applysafetystandards:应用安全
9、标准:- Allloosejewelryremovedintheplant-不许戴松散型项链- Suitableenclosedfootwearinuse(nosandals)-使用专用鞋具。(不用拖鞋)- Protectiveapparelwhereneeded(safetyglasses,earplus,gloves,safetyshoes,helmet,)-在必要区使用专用衣着。- Secureuniformpocketstokeeplooseobjectfromfalling-使用专用服装以防松散物体掉落- Meetalllocalsafetyregulations符合地方法规* Ap
10、plydressandpersonalappearaneecodes:人员穿着与外表要求:- Provideseveralsetsofastandarduniformslaunderedregularly(uniformslightcoloredandofmaterialthatiseasytocleanandabletowithstandindustrialuse)-提供几套标准的洗衣设备(统一用浅色经磨易洗的布料)- Appropriateuniformsfortourguides-参观人员用专门服饰- Defineadresscodeforpeoplewhodontwearuniform
11、s(officeorsalesstaff)-规疋勿需统一着装人员规疋(办公至或销售人员)* Personnelisinformed(trained)abouttherequirementswhenhired在人员入用之前要进行相关要求的知会2Doestheplantfollowthedesignrequirementsforpersonnelfacilities?厂房设计符合人员设备要求吗Ifthesetwoconditionsarenotmet,hotwatershouldbeprovidedinallwashbasins:BO-RQ-200* Handwashstationsprovide
12、din(near)allprocessingareas在加工区域要有洗手池* Soap,disposablehand-towelsorhotairdryers,coveredtrashreceptacles,hotwaterprovided如果以条件不能满足时则要提供热水洗手- suppliedwaterneverfallsbelow20C-所供应水不低于20C- processingequipmentisnotrinsedorwashedinthissink-工艺设备不用在水槽清洗皂液、一次性纸巾或烘手机,有盖的垃圾篓,要有热水* Toiletfacilitiesnottoopendirec
13、tlyintoprocessingareasandequippedwithselfclosingdevices.洗手间的开口不要直接对于加工区域且要配备自动关门* Toiletsarecleanandwellventilated洗手间要清洁通风* Hotandcoldpotablewaterprovidedinalltoilets所有洗手间要冷热两用水* Soap,disposablehand-towelsorhotairdryers,coveredtrashreceptaclesavailableintoilets.皂液、一次性纸巾或烘手机,有盖的垃圾篓,要有热水* Alljointsare
14、sealedandcovedtoeasecleaning所有连接处和密封处、封盖处易清洁* Slopefloortofloordrains,outwatertrapstodrains地面斜坡要斜于排水沟,外面的水流向于排水沟* Handwashsignsinalltoilets所有洗手间要有洗手标识3Areappropriateprogramsinplaceforthehiringofpersonnel?对雇用人员有没有相关的程序。BO-RQ-940* Proceduresforhiringpersonnel(bothcontractandpermanent)areimplementedand
15、include:*实施人没雇用程序(合同式临时式)包括以下条款:- CorporateandDivisionHRrequirements-公司人力要求- Recordsofpreviousemployment-以前员工的记录-Characterreferences-个性参考* Temporaryorcontractpersonnelcanonlyworkinsensitiveareasunderdirectsupervision(presenee)ofafulltimeemployee在专职员工的督下,临时工或合同工才可以在敏感区域工作General4Istheaccesstothefacilitycontrolled?进入设备区受控吗BO-R