Title题目: ISO Level: ISO 级别： Level II Document Type文件类型: Fresenius Medical Care (Jiangsu) Co. Ltd. 江苏费森尤斯医药用品有限公司 LOT NUMBER MANAGEMENT AND PRODUCTION MANAGEMENT FOR MOLDING DEPARTMENT 批号管理和生产管理-注塑 GMP Level: Document Number: Version Number: Page: GMP 级别： 文档序列号： 版本： 页数： N/A CPRD-SOP-002 02 Page 1 of 7 SOP X 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 Molly Mo 莫若宜 Designation / Role: 职位： Head of Production Components Production 塑料部件生产经理 Management Representative 管理者代表 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。
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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 ....................................................................................................................... 4
7. REVISION RECORD/修订记录....................................................................................................... 7
8. ATTACHMENT/附件 ...................................................................................................................... 7
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1.
1.1.
PURPOSE 目的
The purpose of this procedure is to provide a guideline for the identification of components that will allow proper reporting and traceability of materials used, it also shall compile the daily information regarding manufacturing process on the molding area.
提供了注塑部件批号管理方法，确保注塑生产文件和所用原物料的追溯性。同时规定了注塑区生产管理方面的要求。
2.
2.1.
SCOPE 范围
Applies to all molding department machines 适用于注塑部门的所有机器
3.
REFERENCE 参考资料
CQAD-SOP-054
CQAD-SOP-067
Inspection of injection molded components. 射出部件检查
Components history record. 部件产品历史记录。
3.1.
3.2.
4.
4.1.
DEFINITIONS 定义
Scrap: Finished product that either falls to the floor or it is burned material or has embedded particles or any combination of the previously described problems and therefore cannot be regrind further anymore. 报废品：掉落地板上、有烧焦痕迹、埋污或前述的问题集合而造成不可重新粉碎再利用的产品。
Regrind: Left over material, components that is not considered scrap and are later regrind for further reuse. 再生料：剩余原料、部件可重新粉碎再使用的。
Batch size: Production quantity in 24 hours, except potting chamber , flange ,housing and other required by planning .
批量：指24个小时的产量（除注胶室端盖主外壳这些指定的零件），或生产计划要求的数量
4.2.
4.3.
5.
5.1.
AUTHORITY/RESPONSIBILITY 权责
It is the responsibility of the area leader and QA auditor to ensure the identification according to procedure, to ensure the traceable of the components manufactured in molding area.
注塑主管与QA检查员负责根据程序正确识别产品，保证注塑部门生产部件的可追溯性。
The molding group leader should assign the component lot number. 注塑主管负责给定部件批号。
The QA Auditor will verify the assigned lots by Molding area . QA检查员负责确认由注塑主管签核的批号。
Molding machine operator will fill up the forms FPRD-SOP-002-01.
注塑机操作员负责填写表单FPRD-BMR-BL-02-01注塑批记录--生产日志.
5.2.
5.3.
5.4.
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6.
6.1.
PROCEDURE 程序
Injection Lot number assignment 注塑批号管理
The molding area group leader is responsible to assign the component lot number base on work order. 注塑部门主管负责根据生产指令分配部件批号。
Injection Lot Number Nomenclature: 注塑批号命名法 Department 部门 M Month 月份 M Year 年份 Y No. Machine 机器编号 EE Sequence No. during shift 班次序号 S Day 日 DD 6.1.1.
6.1.2.
- -
6.1.2.1. M: It is a constant value and stands for molding. It is used to identify the lot number as an injection lot.
M：恒定不变，代表注塑，表示属于注塑的批号。
6.1.2.2. M: Character used to identify the month on which the lot has been produced. It can take the following values:
M: 用来分辨产品生产的月份，使用下列的意思： A B C D E F G January February March April May June July 一月 二月 三月 四月 五月 六月 七月 H I J K L M August September Omitted October November December 八月 九月 跳过 十月 十一月 十二月
6.1.2.3. Y: One Character used to identify the year on which the lot has been produced. It can take the following values:
Y: 用来分辨产品生产的年份，使用下列的意思。 O P Q R S T etc 2007 2008 2009 2010 2011 2012
6.1.2.4. EE: Two digit numbers that contains the machine number on which the lot was produced (Ex. 01 or 10).
EE:两位数，用来表示机器编号（如：01或10）。
6.1.2.5. S: One digit number used to track the sequence of the lot for a particular machine (indicated on the lot number
“EE” value). This sequence must be reset to 1 at each day change.
S:一位数，来追溯此一台机器生产的批的序列，此序列必须在新的1天复位至1。
6.1.2.6. DD: Two digit number that contains the day of the month on which the lot has been produced.
DD: 用来表示产品生产的当月日期。
? At each day production beginning: as the day character (“DD”) on the lot number changes during the
beginning of a new day, the lot sequence number (“S”) must be reset to 1 on all machines (“E”). Meaning that lot sequential number (“S”) only tracks the number of lots produced for a particular machine line on the running day (“DD”). For housing and flange and potting chamber, the batch size defined as 6.1.2.6.1 and 6.1.2.6.2.
每天的生产开始时：新一天先要更换批号的“DD”日期，每一台机器 “(“E”)”的批号序号“(“S”)”必须要复位至1。意味着批号的序号“(“S”)”只需要记录下特定机器(“E”)每一生产日(“DD”)生产的批次数量。针对主外壳，端盖和注胶室，批量定义见6.1.2.6.1 及 6.1.2.6.2。
? Every time that regrind resin is used on the injection process. If there is a change of resin lot the same
injection lot will continue until completing the requirement. Record the changes of resin lots in the form FQAD-SOP-046-03 in the comments section.
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每次在注塑中使用再生料：树脂批号的变更，同样的注塑批号将继续。使用FQAD-SOP-054-03表单来记录树脂批号的变化。
注胶室批量定义
6.1.2.6.1. For potting chamber, normally the batch size is 96 cartons, equal to 6 pallets.. Only continuous production can
be defined as Batch size definition for housing and flange 端盖和主外壳的批量定义
For housing and flange, normally the batch size is 96 cartons, that means 4 pallets of flange or 6 pallets of housing in each batch. Only continuous production can be defined as same batch，each batch number is
established according to the start date of production and keep unchanged until the number of housing or flange is 96cartons. If there is any special case cause production stop, for example machine down or mould down or production planning adjustment or etc., the batch need to closed even if the batch quantity less than 96 cartons.
针对端盖主外壳，在正常生产中都是96箱为一批，相当于每批4托端盖或6托主外壳。连续生产才能定义为1批，每1批生产批号根据开始生产的日期来制定，且连续96箱不变。如果生产过程被中断，如机器故障或模具故障或生产计划调整，则需对该批进行结批，即使批量少于96箱。
6.1.2.6.2. Batch size definition for potting chamber
same batch，each batch number is established according to the start date of production and keep unchanged until the number of housin
g or flange is 96cartons. If there is any special case need to stop production, for example machine down or mould down or production planning adjustment or etc., the batch need to closed even if the batch quantity less than 96 cartons.
针对注胶室，正常生产中为96箱一批，相当于6托。连续生产才能定义为1批，每1批生产批号根据开始生产的日期来制定，且连续96箱不变。如果生产过程被中断，如机器故障或模具故障或生产计划调整，则需对该批进行结批，即使批量少于96箱。
6.1.3. Injection Production Lot Number Examples:
注塑生产批号样本
MKP031-15, indicates that the tubing was extruded on October , year 2008, Extruder 03, sequence #1, Day 15.
MKP031-15, 表明该压管时间是10月，2008年，机器03号 ，序列号 1 ，第15天。
The lot number for molding components will be recorded by the group leader in the form FPRD-SOP-002-01. 注塑主管将部件的批号记录在表单FPRD-BMR-BL-02-01注塑批记录--生产日志上。
6.2. Printing labels and verification.
打印标签和确认。
6.2.1. Moulding Group leader must issue all the labels to be used during the production lot according to logbooks of lot
number assignment.
注塑主管必须根据批号分配日志，提交本批次生产期间所需要的标签。
6.2.2. The labels should have at least the following information:
标签至少需要包含以下信息。
Material number/ 物料代码 Lot number / 批号
Consecutive box /包装序列数 Quantity /数量
6.2.3. The number of labels can be based on the expected boxes to be completed during the lot.
标签的数量根据在全部期间将完成的箱数确定。
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