回收料使用的控制程序电子教案

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 ⅢN/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。

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)

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 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