过程检验控制程序
In-Process Quality Control Procedure
文件编号 / Document No.:
版次 / Revision:
拟制部门 / Issue Department:
拟制日期 / Issue Date:
QP-826 A00 Quality 12/11/2007
受控标志 / Chops:
T-AI-420-B001-01
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QP-826
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会 签 表 / Reviewal Department
部门 / Dept 姓名 / Name 日期 / Date 部门 / Dept 姓名 / Name 日期 / Date Marketing R&D Manufacturing Production Administration Human Resource Quality Program Management Financial Management Representative Top Management Warehouse Purchase Sales
更改控制 / Revision History
页次 / Page 版次 / Rev. 日期 / Date 修改内容 / Contents of Change 修改人 / 批准人 / Changed Approved by: by: T-AI-420-B001-01
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QP-826
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1. 目的 / Purpose
为保证不合格的产品不到下一工序,对生产过程中出现的不良因素进行控制,并规
范试验过程,特制订本程序。
To control the unhealthy factors that aroused during manufacturing process and to prevent the nonconforming products from being leaked to next process, as well as standardizing the experimental process.
2. 适用范围 / Scope
本程序适用于锂离子二次电池生产过程的检验和试验工作。
Applicable to the in-process control and experimental process of rechargeable Lithium-Ion Battery.
3. 术语和定义 / Terms and Definition
无 / Nil
4. 职责和权限 / Responsibility
4.1. 生产部
Production
4.1.1. 负责组织生产过程各工序的自检,不允许有批量不合格品流到下一
工序。
Responsible to implement the self check process in production, and preventing epidemic nonconforming products from leaking to next process.
4.2. 制造工程部
Manufacturing Engineering (ME)
4.2.1. 负责制定标准作业文件和产品标准,负责试验方案的提出,必要的
试验由制造工程部负责完成,并对试验资料管理。
Responsible for the establishment of SOP and product standards, and proposing the experimental plan. The essential experiment
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shall be carried out by ME, as well as experiment data
management.
4.3. 品质部
Quality Department
4.3.1. 负责检验文件的编写,负责组织巡回抽样检验,并对检验数据负责。
Responsible for the establishment of inspection documentation,
organizing line patrol to perform sampling inspection and bearing responsibility on inspection data.
5. 流程图 / Flow Chart
无 / Nil
6. 活动内容 / Activities Description
6.1. 首件检验
First Article Inspection (FAI)
6.1.1. 操作员参照PMP对规定的工序进行首件检验,并将检验结果填入相
应工序的首件记录表中,并通知IPQC人员对其工序首件进行确认,合格后方可进行批量生产。
The operator shall perform FAI for the processes defined in PMP, and record the inspection result into correspondent FAI forms. The operator shall inform IPQC to verify the FAI of the process, and permission for production shall only be granted if the FAI result is confirmed to fulfill specification.
6.1.2. 对首检不合格的要求其重做,直到合格,并将检验结果填入相应工
序首件记录表,由IPQC签名确认后该工序可进行生产。
If the FAI is failed, the inspection shall be repeated until fulfilling the requirements. All the inspection results shall be recorded into correspondent FAI record forms and verify by IPQC. Production can be resumed after the records verified and signed by IPQC.
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6.1.3. 检验依据为制造工程制定的产品标准、工艺标准、作业指导书、相
关的对策和品质制定的检验文件。
Inspection reference shall be base on product standard, process standard, work instruction (WI) and relevant inspection documentation.
6.1.4. 应用品质统计技术的原理,按“数据分析程序”的有关规定对检验
数据进行分析。
The inspection data shall be analyzed according to the definition in “Data Analysis Procedure” by applying statistical application.
6.2. 自检、互检
Self-check, buddy-check
6.2.1. 生产线工人必须严格依照工序作业指导书进行生产,并对自己生产
的产品进行自检,以防不合格产品批量进入下一工序,同时下一工序员工对上工序的产品应进行经常性互检,发现不良时及时反馈信息。
The operator shall strictly follow the WI to perform the work and performing self-check on produced product to prevent nonconforming product from being leaked to next process. Meanwhile, the next process operator shall cross check
(buddy-check) the product from previous process and feedback to previous process operator if there is any defect found.
6.2.2. 当工人自检到不合格品时要跟正常品区分,按“不合格品控制程序”
执行。
The nonconforming product detected during self-check shall be separated from normal product and handled according to “Nonconforming Product Control Procedure”.
6.3. 巡检
In-Process Quality Control (IPQC)
6.3.1. 巡检的范围包括PMP规定的检验项目、员工的作业规范、工艺执行
情况、产品的异常波动及突发事件、各种原辅材料投入前的确认、纠正措施的实施及效果确认、不合格品的处置、产品的防护及工艺对环境的要求等。
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The scope of IPQC shall include: inspection items defined in
PMP, operator’s working standard, process execution status, fluctuation of abnormities and unexpected incidents,
verification of input materials, verification of corrective action implementation and its effectiveness, handling of nonconforming product, product handling and protection, process environment requirements and etc.
6.3.2. 巡检的不良品按“不合格品控制程序”执行,产品异常时要求停产
及填写“CLCA”并送相关工艺工程师处理,同时通知品质主管。
The nonconforming product detected by IPQC shall be handled according to “Nonconforming Product Control Procedure”, and IPQC shall request for line stop if there is abnormities found in product. A “CLCA” shall be issued to related PE for handling and informing to QA supervisor about the incident.
6.4. 定点检验
Final Quality Assurance (FQA)
6.4.1. 品质部按PMP和实际需要确定生产线上的检验工位。
FQA is referring to the inspection post arranged at production line by Quality Department, base on the requirements in PMP and actual needs.
6.4.2. 定点检验工位工人依照检验文件对产品进行检验,并将检验结果汇
总到“FQA Inspection Plan”。
The FQA inspector shall perform inspection with reference to relevant inspection documentations, and record the inspection to “FQA Inspection Plan”.
6.4.3. 对于检验为不合格的产品按“不合格品控制程序”执行。
The nonconforming product detected by FQA shall be handled according to “Nonconforming Product Control Procedure”.
6.5. 必要的试验
Essential Experiment
6.5.1. 开发新产品、工艺试验、顾客要求和按国家法律法规规定进行必要
的试验。
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The experiment shall be carried out essentially for new
developed product, process experiment, customer requirement or according to laws and regulation requirements by government.
6.5.2. 试验方案由制造工程部提出,试验的内容包括:试验项目、试验目
的、试验内容与要求、试验过程与结果、结论、试验负责人及完成时间等。
The ME department shall propose the experiment plan, which includes: experiment items, experiment purpose, contents and requirements of experiment, experiment process and result, conclusion, responsible person, completion time and etc.
6.5.3. 试验方案经审核后,由总工、分管副总或其授权人批准后方可进行。
The experiment plan shall only be implemented after approval
by Head of Engineering, Vice General Manager or authorized personnel.
6.5.4. 各项试验由试验负责人填写有关原始数据,做出试验报告并呈报部
门负责人批准,试验负责人对试验数据负责,试验记录由制造工程负责管理。
The responsible person shall record down the test data of each experiment item, and prepare an experiment report for
submission to department head for approval. The experiment record shall be kept and managed by ME.
7. 表格和纪录 / Forms and Records
7.1. F-QP-826-01 试验报告
F-QP-826-01 Experiment Report
8. 相关文件 / Related Documents
8.1. AI-826-B001 首件、三检作业管理规定
AI-826-B001 FAI, Self-Check, Buddy Check & Special Check Management Instruction
文件编号: Doc. No:
QP-826
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8.2. CAI-826-B002 制程停线控制实施细则 Line Stop Control Instruction
8.3. QI-826-E000 制程管理计划
Process Management Plan 8.4. QP-851 纠正措施管理程序
QP-851 Corrective Action Management Procedure 8.5. QP-830 不合格品控制程序
QP-830 Nonconforming Product Control Procedure 8.6. EP-730 设计和开发控制程序
EP-730 Product Design and Development Control Procedure 8.7. MP-750 生产和服务运作控制程序
MP-750 Production and Service Provision Control Procedure
9. 附录 / Attachments
无 / Nil