PRINTEDON1/15/20189:30PMFRESENIUSFreseniusMedicalCare(Jiangsu)Co.Ltd.MEDICALCARE江苏费森尤斯医药用品有限公司Title题目：CONTROLLINGPROCEDUREOFRECYCLEMATERIALSUSING回收料使用的控制程序ISOLevel:ISO级别：GMPLevel:GMP级别：DocumentNumber:文档序列号：VersionNumber:版本：Page:页数：LevelIIIN/ACPRD-SOP-O1902Page1of6DocumentType文件类型：SOPmOtherApproval/批准Author:编写者：JackLu陆敬杰Designation/Role:职位：InjectionMoldingSupervisor注塑主管Signature:签名：Date:日期Bysigningthisdocument,通过签名，确认本人即为本Note:Signatureanddate注itistoconfirmthatIamtheauthor;thisdocumentispreparedaccordingtotechnicalstandards.m文编写者；且本规程是参照技术标准编写的。3areonlyrequiredforMasterCopy,whichiskeptinQualityDepartmentZ和日期，并被保存在质量部。Approver:批准人：Peterzhu朱玉军Designation/Role:职位：HeadofProductionComponentsProduction塑料部件生产经理Signature:签名：Date:日期Bysigningthisdocument,itistoconfirmthatthisdocumentisfitfortechnicalstandardsandfitforrelease.通过签名，确认本文件符合技术标准并准予发行。Note:SignatureanddateareonlyrequiredforMasterCopy,whichiskeptinQualityDepartment注意：只有主文件需要签名和日期，并被保存在质量部。ConfidentialProprietaryInformation公司保密信息lAld0£：68L03/9L/LNOQ^lNIHduoiteiujojuiAjetsudojdlenuspijuog9#^/lN3l/\IH0VHV89沁!1K/GHOCOHNOISIA3d'L£W/Banaaooad9£tfWAiniaiSNOdsaa/AiiaoHinvw£K^/SNOiiiNidaap£ttMW/3ON3d3d3dC£H^/3dOOS'乙£Ml/asodaridJ沓目siueiuogjoaiqei迫9畀迫？蚩30-6l-0-dOS-aad9/9)03o6ed3Q-6l-0-dOS-aad91.PURPOSE目的1.1.Establishrecyclingprocessofshuikoumaterialsandrecycledunqualifiedinjectionproducts,toensurethatthequalityoftheinjectionproductsmeetstherequirement.建立水口料和可回收的报废注塑件的循环使用流程，以确保注塑件的质量达到规定要求。2.SCOPE范围2.1.Thisprocedureappliestotheshuikoumaterialsandrecycledunqualifiedinjectionmoldingpartsofallproducts.本程序适用于注塑区所有产品的水口料和可回收的不合格注塑件。3.REFERENCE参考资料3.1.CPRD-SOP-046-01PULVERIZERINSTRUCTIONCPRD-SOP-046-01粉碎机工作指导书3.2CPRD-SOP-047-01SIEVEMACHINEINSTRUCTIONCPRD-SOP-047-01筛选机工作指导书3.3FPRD-SOP-040-03MOLDINGDEPARTMENTSET-UPGUIDEFPRD-SOP-040-03《注塑设置指南》3.4FQAD-SOP-054-03INJECTIONMOLDINGPROCESSMATERIALSLOGBOOK4.FPRD-BMR-BL-02-01《注塑批记录生产原料日志》5.DEFINITIONS定义N/A无6.AUTHORITY/RESPONSIBILITY权责6.1.ProductionDepartmentResponsibilities生产部职责5.1.1Ensuringthatthematerialiscorrespondstotheproduct.确保物料与所要生产的产品相符。5.1.2Changingcontainerlabeleverytimematerialisissuedtotheline.每次向生产线发出物料时及时更换容器上的标签。5.1.3Replacefullchamber'scontainerswithemptycontainersfromthechamber/topcap/filtermachine.及时用空的容器更换机台水口料的满容器。5.1.4Ensuringthatthemixingratioisright,notbeyondthespecifiedrequirement.Anddother确保物料配比正确，未超过文件规定，并做好相关记录。5.1.5Thesupervisor/designeeisresponsibleforconductingrandomauditsofthelinestoverifythatthephysicalmaterialmatchesthemanagementsysteminventory.主管或其代理人负责对生产线进行随机检查以确认实际使用的物料与管理系统中信息相符。6.2.QualityAssuranceDepartmentResponsibilities:QA部门职责ConfidentialProprietaryInformation公司保密信息PRINTEDON1/15/20189:30PMCPRD-SOP-019-02Page5of6/CPRD-SOP-019-02第4页共6页ConfidentialProprietaryInformation公司保密信息PRINTEDON1/15/20189:30PMCPRD-SOP-019-02Page5of6/CPRD-SOP-019-02第5页共6页ConfidentialProprietaryInformation公司保密信息...
