| Frenius 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 Ⅲ | N/A | CPRD-SOP-019 | 02 | Page 1 of 6 |
Document Type 文件类型: | SOP √ Other___________________________ |
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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 relea. 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。 |
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Table of Contents
目录
1. PURPOSE / 目的 3
2. SCOPE / 范围 3
3.gre官网 REFERENCE /参考资料 3
4. DEFINITIONS / 定义 3
5.初中物理电学公式大全 AUTHORITY/RESPONSIBILITY /权责 3
6. PROCEDURE /程序 3
7. Revision Record/修订记录 6
8.初一上学期英语 Attachment/附件 6
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andrew garfield
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
gelang3.2 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 chamber’s 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
5.2.1 Supervi 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 cau 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 nd them to crushing workshop. |
布莱尔 邓文迪生产人员 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 caus the material crushed unqualified. | 严格按照《粉碎机工作指导书》进行粉碎。 garageStrictly 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 sheet《Mixing 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 nd 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 supervis 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 supervis mixing materials randomly. |
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6.2 The recycle control process of shuikou materials and recycled unqualified injection products:
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 productsparameters是什么意思, 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 u 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.商务时间 Before crushing shuikou materials, workers confirm whether there are foreign substances,nude 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.
