环保认证-CCAEPI-305-2009(环境保护产品认证工厂质量保证能力要求--中英文版)

1中环协(北京)认证中心公开文件PublicfilesofCAEPItoanyonewhomayconcernCCAEPI-GK-305-2009环境保护产品认证工厂质量保证能力要求MANUFACTURERS’QUALITYCONTROLABILITY（QCA）REQUIREDBYCERTIFICATIONOFCHINAASSOCIATIONOFEVIROEMENTPROTECTIONINDUSTRY（CCAEPI）2009年*月*日颁布2009年*月*日实施Publishedat2009.*.*Executedsince2009.*.*中环协(北京)认证中心发布ISSUEDBYCAEPI23环境保护产品认证工厂质量保证能力要求MANUFACTURERS’QUALITYCONTROLABILITY（QCA）REQUIREDBYCERTIFICATIONOFCHINAASSOCIATIONOFEVIROEMENTALPROTECTIONINDUSTRY（CCAEPI）(CCAEPI-GK-305-2009)本文件规定了申请环保产品认证企业工厂质量保证能力应达到的要求。申请环保产品认证的企业应满足并持续满足本文件的要求。本文件是CCAEPI-GK-305-2005的改版。ThisfilestipulatedtherequirementsonQCabilityofmanufactureswho’sapplyingforCCAEPI.Theappliershallmeettherequirementslistedinthisfileaslongasitneeded.ThisfileistherevisedversionofCCAEPI-GK-305-2005.1．职责和资源1.ResponsibilitiesandResources1.1职责1.1Responsibilities工厂应规定与产品质量活动有关的各类人员的职责及相互关系。Themanufacturershallprescribetheresponsibilitiesandrelationshipsofandbetweeneverypersonwho’srelatedtoQCactivities.工厂应指定一名质量负责人，授权其负责建立满足本文件要求的质量体系，并确保其实施和保持。ThemanufacturershallassignaQCmanager,authorizedtoestablishQCsystemwhichcanmeettherequirementsstipulatedinthisfile,andmakesuretheQCsystemiswellimplementedduringproducingprocesses.质量负责人应具有充分的能力胜任本职工作。TheQCmanagershallbecompetentforthisjob.1.2资源1.2Resources工厂应配备必要的生产设备和检验设备以满足稳定生产符合认证标准的产品要求。应配备相应的人力资源，确保对产品质量有影响的人员具备必要的能力。建立并保持适宜产品生产、检验、试验、储存等必要的环境。4ThemanufacturershallbeequippedwithessentialequipmentsforproducingandQCprocessing,tomakesurethattheycanstablyproducingproductswithqualitythatcanmeettherequirementsofCCAEPI;andshallprovidecorrespondinglythehumanresources,toinsurethatthepersonsrelatedtoQCsystemhasthenecessarycapability;andshallestablishandkeepasuitableandessentialenvironmentforproducing/QC/testing/storageetc.2．质量文件和产品标准2.QCfilesandStandardsfortheproduction2.1工厂应建立并保持文件化的产品质量管理文件，以确保产品质量的相关过程有效运作。2.1ThemanufacturershallestablishandkeepaQCfilesystem,toinsureeveryprocessingrelatedtoQCcanbeoperatedeffectively.2.2应有完整的产品设计文件和工艺文件，审批手续完备2.2Themanufacturershallprovidedintegratedfilesontheproducts’designsandproducingprocedures,withanintactapprovalprocedure.2.3产品生产应按照相应的标准（一般为企业标准）组织生产，并能有效指导和控制产品质量；产品企业标准应在当地质量监督管理部门备案（登记），且产品标准技术性能要求应不低于该产品的认证标准要求。2.3Theproducingproceduresshallbeaccordingtotherelevantstandards(enterprisestandardasusual),whichcaneffectivelyguideandcontroltheproductionquality;theenterprisestandardshallberegisteredatlocalproductionqualityregulatoryagencies,andthetechnicalstandardsforthisproductionshallnotlowerthanasrequiredinthisfile.3.供应商质量控制3.Qualitycontrolonthesuppliers3.1工厂应制定《关键元器件和原材料供应商清单》，并建立供应商档案。3.1Themanufacturershallmakealistofsuppliersofthekeycomponentsandrawmaterials,andmaketherecordsarchives.3.2工厂应对外协件加工方提出文件化的质量要求，并建立质量验收档案记录。3.2Themanufacturershallputforwardaclaimonqualityrequirementstosuppliers,andmaketherecordsarchives.3.3工厂应对关键元器件和原材料供应商、外协件加工方进行定期评审，确保其提供的产品持续符合认证及相关标准要求。相关记录完整有效。3.3ThemanufacturershallexamineandcommentontheQCofkeycomponentssuppliersregularly,tomakesurethattheycanstablysupplythestandardproducts,andmaketheintegratedrecordsarchives.4.生产过程控制4.Producingprocedurescontrol4.1工厂应对影响产品质量的关键生产工序进行识别，如果该工序没有文件规定就5不能保证产品质量时，则应制定相应的工艺文件、作业指导书，使生产过程受控。4.1Themanufacturershallrecognizeeverykeyprocedureduringproducing,andshallconstituterelevanttechnicalfiles&operationguidanceifitisnotavailableinthekeyprocedures,tomakesuretheproducingproceduresarealwaysundercontrol.4.2关键工序操作人员应经过相关技能培训，具备相应能力。4.2Thepersonsinthekeyproducingprocessesshallbewelltrained,andcompetentforthekeyprocedures.4.3工厂应建立并保持生产设备管理（操作维护保养）制度。4.3Themanufacturershallestablishandkeepanintegratedmanagingsystemontheproducingequipments.5.例行检验和型式检验例行检验包括关键元器件和原材料进厂检验/验证、工序检验和出厂检验。型式检验是为验证产品持续符合企业标准要求进行的检验。5.RegulartestingandPerformancestestingRegulartestingincludingthetestingonthekeycomponentsandrawmaterialsbeforeputintotheproducingprocedures.Performancetestingisfortestingthequalityoftheproductionbeforeleavethefactory.5.1关键元器件和原材料的检验/验证5.1Testingonthekeycomponentsandrawmaterials工厂应建立并保持对供应商提供的元器件和原材料的检验或验证的作业指导书，以确保其质量满足要求。Themanufacturershallestablishandkeeptheintegratedfilessystemsuchasproducingguidanceforthecomponentsandrawmaterialtothesupplier,tomakesurethequalitycanmeettherequirements.关键元器件和原材料的检验可由工厂进行，也可以由供应商完成。当由供应商检验时，工厂应对供应商提出明确的检验要求。Thetestingonthekeycomponentsandrawmaterialscanbeexecutedbythesupplierorthemanufacturerthemselves.Themanufacturershallclearlyputforwardthetestingrequirementstothesupplierifit’stestedbythem.工厂应保存完整有效的关键元器件和原材料的检验或验证记录及供应商提供的合格证明及有关检验数据等。Themanufacturershallmakeintegratedfilesystemsontestingrecordsofthekeycomponentsandrawmaterials,andalsothetestingdataandqualitycertificationsshallbeprovidedbythesuppliers.5.2工序检验5.2Processingtesting工厂应建立并保持文件化的对关键工序生产结果的检验检验规程或作业指导书，6明确规定检验的抽样方法、检验项目、适用方法、判定规则等，以确保其结果满足工序质量要求。Themanufacturershallestablishandkeepintegratedfilesystemonproducingguidanceandperformancetestingregulationsforthekeyprocedures,clearlyprescribingthesampling/testingprojects/applicationstandards/judgmentstandardsetc.,tomakesuretheresultcanmeettheprocedurequalityrequirements.工厂应保存完整有效的关键工序检验的记录。Themanufacturers