回收料使用的控制程序.doc

. 可编辑修改 1 Fresenius Medical Care (Jiangsu) Co. Ltd. 江苏费森尤斯医药用品有限公司 Title 题目: CONTROLLING PROCEDURE OF RECYCLE MATERIALS USING 回收料使用的控制程序 ISO Level: ISO 级别： GMP Level: GMP 级别： Document Number: 文档序列号： Version Number: 版本： Page: 页数： Level N/A CPRD-SOP-019 02 Page 1 of 6 Document Type 文件类型: SOP Other_ Approval/批准 Author: 编写者： Jack Lu 陆敬杰 Designation / Role: 职位： Injection Molding Supervisor 注塑主管 Signature: 签名： Date : 日期 By signing this document, it is to confirm that I am the author; this document is prepared according to technical standards. 通过签名，确认本人即为本文编写者；且本规程是参照技术标准编写的。 Note: Signature and date are only required for Master Copy, which is kept in Quality Department 注意：只有主文件需要签名和日期，并被保存在质量部。 Approver: 批准人： Peter zhu 朱玉军 Designation / Role: 职位： Head of Production Components Production 塑料部件生产经理 Signature: 签名： Date : 日期 By signing this document, it is to confirm that this document is fit for technical standards and fit for release. 通过签名，确认本文件符合技术标准并准予发行。 Note: Signature and date are only required for Master Copy, which is kept in Quality Department 注意： 只有主文件需要签名和日期，并被保存在质量部。 . 可编辑修改 2 Table of Contents 目录 1. PURPOSE / 目 的 .3 2. SCOPE / 范 围 3 3. REFERENCE /参 考 资 料 .3 4. DEFINITIONS / 定 义 .3 5. AUTHORITY/RESPONSIBILITY /权 责 .3 6. PROCEDURE /程 序 3 7. REVISION RECORD/修 订 记 录 6 8. ATTACHMENT/附 件 .6 . 可编辑修改 3 1. PURPOSE 目 的 1.1. Establish recycling process of shuikou materials and recycled unqualified injection products, to ensure that the quality of the injection products meets the requirement. 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. This procedure applies to the shuikou materials and recycled unqualified injection molding parts of all products. 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-046-01 PULVERIZER INSTRUCTION CPRD-SOP-046-01 粉碎机工作指导书 3.2 CPRD-SOP-047-01 SIEVE MACHINE INSTRUCTION CPRD-SOP-047-01 筛选机工作指导书 3.3 FPRD-SOP-040-03 MOLDING DEPARTMENT SET-UP GUIDE FPRD-SOP-040-03 注塑设置指南 3.4 FQAD-SOP-054-03 INJECTION MOLDING PROCESS MATERIALS LOG BOOK 4. 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. Production Department Responsibilities 生产部职责 5.1.1 Ensuring that the material is corresponds to the product. 确保物料与所要生产的产品相符。 5.1.2 Changing container label every time material is issued to the line. 每次向生产线发出物料时及时更换容器上的标签。 5.1.3 Replace full chambers containers with empty containers from the chamber/ top cap/filter machine. 及时用空的容器更换机台水口料的满容器。 5.1.4 Ensuring that the mixing ratio is right, not beyond the specified requirement. And do the r 确保物料配比正确，未超过文件规定，并做好相关记录。 5.1.5 The supervisor/designee is responsible for conducting random audits of the lines to verify that the physical material matches the management system inventory. 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. Quality Assurance Department Responsibilities: QA 部门职责 . 可编辑修改 4 5.2.1 Supervise that the materials are not mixed during the manufacturing process and the mixing ratio is qualified. 监督物料在生产过程中未发生混淆和物料配比合格。 7. PROCEDURE 程 序 6.1 The recycling material control process in the following chart: 回收料的控制流程如下图所示： 流程图 Flow Chart 责任人 Responsible Part 风险 Risk 措施 Action 生产人员 Production Staff A.生产水口中混入异物、 杂质、金属黑点、油污、 被污染或其他产品等； A. There are impurity, oil, metal, polluted, foreign matters, or other products, B. 不良注塑件的缺陷 造成不能立即回收。 B. The defects cause unqualified injection parts not recycle immediately. A.水口料在粉碎前进行确认，合格则 粉碎； A. Confirm the shuikou materials whether qualified, if they are qualified, then crushed. B. 可回收的不良注塑件根据缺陷分 类处理后在送至粉碎车间进行粉碎。 B. Deal with the unqualified products on the basis of different defect kinds, and then send them to crushing workshop. 生产人员 Production Staff 在粉碎过程中混入杂质， 造成粉碎后料不能使用。 Mixing impurity in crushing process, it causes the material crushed unqualified. 严格按照粉碎机工作指导书 进行粉碎。 Strictly crush according to Pulverize Instruction. 生产人员 Production Staff 生产主管 Production Surpervisor A.配比超出文件规定的 范围； A. Mixing ratio is beyond documented range. B.在混料时，用错原料 粒子和回收料； B. Add wrong particles and recycle materials, when mixing. A对添加的 原料 和回收料进行称量， 从而控制所添加的量并记录在配料 日报表中； A. Weigh flesh material and recycle material and record mixing ratio in the sheetMixing Materials Daily Report B拌料标识清楚，贴好拌料标识 单送至机台，从而防止使用错误的 料生产产品。 B. Label clear with Mixed material ID and send the materials to relevant machine, to prevent using wrong materials to production. C品管监督配比过程，查看物料是 否发生混淆。 C. QM supervises the mixing process, and checks the material whether is wrong. D.生产主管随机确认和监控。 D. Production supervisor checks and supervises mixing materials randomly. 6.2 The recycle control process of shuikou materials and recycled unqualified injection products: . 可编辑修改 5 水口料和不良品循环使用管控流程： 6.2.1 Before loading leftover materials and recycle unqualified injection products, the plastic barrels should be labeled with Recycle material ID to indicate the material name, date, operator, lot number, machine number. If there are some problems, they can be traced. 胶桶在装水口料/废品前，需贴上 回收料标识单 ，注明原料名称、 日期、操作员、 批号、机台号，以便发 现问题时，能追溯。 6.2.2 Workers use clean plastic barrels to hold leftover material and unqualified injection products, and put the cover timely. The recycle materials of different products cannot be mixed together in one barrel. 员工把水口料和不良品放在干净的塑料桶中，并及时把桶盖上做好防护工作。不同回收料不得混在一起放置。 6.2.3 When leftover materials are full, the plastic barrels are transported to crushing workshop. Before crushing shuikou materials, workers confirm whether there are foreign substances, impurity, metal or other products and so on. If there are unclean recycle materials, clean the materials before crushing. If the shuikou materials are dropped on the ground and polluted, then there are scrapped. 水口料的塑料桶满后，拉至粉碎车间。在粉碎前确认水口料里是否有异物、杂质、金属或其他产品等。若有 不干净的水口料，则在碎料之前处理干净再进行碎料。掉落在地面的水口料和被污染水口料则以报废处理。 6.2.4 Before the recycle unqualified injection parts transported to crushing workshop, workers deal with the unqualified products on the basis of different defect kinds, clean the unqualified products with oil, dark point, foreign substance and so on. After cleaning, transport them to crushing workshop. 可回收不良注塑品在拉至粉碎车间前，员工根据不良注塑品的缺陷不同分类进行处理，把有油污、黑点、异 物等缺陷的不良品清除。清理干净后拉至粉碎车间粉碎。 6.2.5 Crushing recycle according to CPRD-SOP-046-01 PULVERIZER INSTRUCTION. 按 CPRD-SOP-046-01粉碎机工作指导书进行粉碎。 6.2.6 Weigh the weight of crushed recycle materials, fill Re-grindded material ID and store them neatly in the designated area. 粉碎好的回收料装好称重， 填写 粉碎料标识单 , 在指定的区域堆放整齐。 6.2.7 Unusable recycle materials are scrap process according to companys procedure. 无法使用的回收料按公司流程予以报废处理。 6.2.8 Workers should clean the mixing barrel before mixing materials, using air gun to clean the foreign substance, masterbatch and so on. 配料员在配料前，须将混料筒内清理干净,用气枪吹尽混料筒内的异物、色母等。 6.2.9 When mixing materials, operator add the recycle materials no more than the documented mixing ratio and stir well. The mixing ratio is defined in FPRD-SOP-040-03 Molding department set-up guide Injection setting manual according to the mixing ratio when validation. Add the dosage of masterbatch according to the new particles, do not mixing wrong recycle materials. Record every mixing dosage and batch and mixing ratio in the sheetMixing Materials Daily Reportand hand in workshop supervisor to confirm. The article NO and batch of recycle material is same as the fresh material which produce recycle material. 掺混回收料时， 配料员按照回收料配比表加入不超出规定比例的回收料 ，并确保搅拌均匀。 回收料的配比规 定依据 FPRD-SOP-040-03 注塑设置指南 上验证时回收料配比。 按所加新量多少来添加色母用量，不可 用错回收料。每次配好料后需记录下配料量、 批号 和配比，做好配料日报表上交车间主管确认。 回收料 的物料代码和批号与产生回收料的原料的代码和批号一致。 6.2.10 Transport the plastic barrels filled with mixed materials to the injection machine. Do not fill too much mixed materials in the plastic barrel, spill on the ground and put the cover timely. Label on the plastic barrel of the the material name, batch of fresh material, batch of recycle material, batch of color resin, ratio of recycle material, date, operator. . 可编辑修改 6 搅拌好的料装入塑料桶送到各机台。向塑料桶中装料时，不可加得过多，严禁将料弄洒于地面上，及时盖上 塑料桶。在塑料桶上做好标示，注明粒子名称、 原料批号、次料批号、色母批号、回收料比例、日期、拌料 人。 6.2.11 Inspection operator at the machine record the batch of fresh material, batch of recycle material, ratio of recycle material, batch of color resin. Then finish the writing work for Injection molding process material log book FQAD-SOP-054-03 机台全检人员根据塑料桶上的标示记录下每桶料的原料批号、回收料批号、回收料比例，色母批号、做好 FPRD-BMR-BL-02-01 注塑批记录 -生产原料日志 填写工作。 8. Revision Record 修 订 记 录 Version 版本 Description of Changes 修改内容 Originator 起草人 Effective Date 生效日期 01 New 周承超 2013-05-29 02 Modify 6.1, 6.2.1, 6.2.6, 6.2.9, 6.2.10 to detail the record of recycle material Add 6.2.11 Add 8.2 Mixing ratio of recycle material 修改 6.1, 6.2.1, 6.2.6, 6.2.9, 6.2.10 以详细定义回收料的记 录 增加 6.2.11 增加 8.2-8.5 李延 2016-01-04 03 修改 FQAD-SOP-054-03 注塑生产原料日志 为 FPRD-BMR-BL-02-01 注塑批记录 -生产原料日志 9. Attachment 附 件 8.1 FPRD-SOP-019-01-02 Mixing Materials Daily Report 配料日报表 8.2 FPRD-SOP-019-02-01 Mixing ratio of recycle material 回收料配比表 8.3 FPRD-SOP-019-03-01 Recycle material ID 回收料标识单 8.4 FPRD-SOP-019-04-01 Mixed material ID 拌料标识单 8.5 FPRD-SOP-019-05-01 Re-grinded material ID 粉碎料标识单