实验室管理程序(中英文)

实验室管理程序

laboratory management procedure

（IATF16949-2016）

1. 目的 Objective

建立本制度, 确保各实验设备正常的使用, 保证产品质量满足客户需求。

To ensure all the laboratory devices can be used normally and ensure the product quality can meet the customer requirements.

2. 适用范围 Applicable Scope

本公司实验室包含:DQA 测试室、实验室、老化室。

The laboratory of our company includes DQA test room, laboratory and aging room.

3. 职责 Responsibilities

3.1. 生产部：负责提供抽样实验所需的在线产品。

Production department: provide on-line product for sampling experiment.

3.2. 品质部：负责研发产品、在线产品、最终产品等各种型式实验的实施和中止，实验 异常的初步分析与异常的反馈、实验状况的记录与统计，实验仪器、设备与工装的 日常保养。

Quality department: implement and discontinue various types of

experiments, such as R&D products, on-line products, and final products. Analyze and feed back the test abnormity, record the test results and do the statistics, implement the daily maintenance of the instruments, devices and fixtures.

3.3. 工程部：负责试产样品、中途变更产品的提供及实验申请与实验中异常的分析，在 线产品抽验不良的分析，实验仪器、设备的校验与定期维护。

Engineering department: provide trial samples and engineering changed product, apply for the test, analyze the abnormalities happened in the test and in the production, implement the instruments calibration and periodic maintenance.

3.4. 研发部：负责研发产品实验的申请与实验中产生不良的分析。

R&D department: put forward the test application for the R&D product and analyze the nonconformities in the test.

4. 实验室设备使用管制流程 laboratory device control procedures

5. 相关实验作业及说明 relevant testing operation and explanation

5.1实验室品质政策:早期发现产品潜在性问题, 落实问题改善与追踪确认, 确保产品符合 市场要求。

Laboratory quality policy: find the potential failure in the earlier

stage, and follow the related improvement to ensure the product meet the market requirements.

5.2实验室品质系统:新产品导入量产前的试作, 依 DQA 各项规范的可靠性实验验证, 落实 问题改善完毕与标准作业建立, 确保量产质量效率的达成。

Laboratory quality system: new product trial making, reliability verification according to the DQA regulations, follow the improvement and standard operation establishing, ensure the quality efficiency be reached in the mass production.

5.3实验室指标:各实验室执行相应实验, 确保和及时提供产品 DQA 可靠性状况以满足生产 部生产性的需求, 确保产品于管控范围内。

Laboratory objective: each laboratory shall implement the corresponding test, make sure to provide product DQA reliability results timely and it can meet the production requirements, and ensure products are under control.

5.3.1DQA 测试室:执行新产品功能测试验证与报告作成。

DQA test room: implement new product function test and make the report.

5.3.2实验室:执行提供产品环境动态和保存实验，其它可靠性实验。

Laboratory: implement the product environment dynamic test and record the results and provide it, implement other reliability tests.

5.3.3老化室:执行提供产品加速寿命实验.

Aging room: implement the product aging test.

5.4. 实验室人员：Laboratory personnel:

5.4.1工程师:相关科系专业或工作经验三个月以上者。

Engineer: major in relevant field or has relevant work experience for more than three months.

5.4.2实验员:中专、高中学历, 工作经验三个月以上者。

Laboratory operator: graduated from technical secondary school or high school, and has relevant work experience for more than three months.

5.5. 实验室标示、实验与记录 laboratory mark, test and record

5.5.1. 对实验品以标示记录, 试验品完成实验后将归还研发或工程，此样品可分发工程、 生产、品质作测试治具或教育训练样品用。

The test product shall be marked, after the test is finished, the test product shall be returned to R&D or engineering department, the sample can be distributed to engineering department, production department, quality department to be used as test fixture or training sample.

5.5.2. 实验中所有问题缺失将由责任单位提出有效解决对策于报告书中, 确保问题追踪结案。

The responsible department shall put forward effective solution for the