Laboratory management Procedure 实验室管理程序（中英版）

1、QUALITY SYSTEM PROCEDURE 质 量 体 系 程 序Number 文件编号:PD-S3-02Department 部门:QA 质量部 Subject 文件名称:Laboratory management Procedure 实验室管理程序Revision版本: 2.0Effective Date生效日期:2012-10-31Page 4 of 4批准：审核：作成：Change History变更记录Revision 版本Effective Date生效日期Originator编写人Reasons for Change修改原因2.02012-10-31Sandy He保持外部

2、实验室资质证明1.0 PURPOSE 目的1.1 This document defines the management regulation for the laboratory and ensures that the system is effective and the quality of tests and calibration results are valid.定义实验室管理规范，保证测试的有效性。2.0 SCOPE 范围2.1 Apply to the people activities and test in the laboratory. 适用于对实验室人员和相关实验

3、活动的管理。3.0 DEFINITIONS定义None 无4.0 REFERENCE DOCUMENTS参考文件4.1 ISO/TS 16949 Clause Laboratory requirements 实验室要求5.0 RECORDS 记录5.1 FN-QA-023 测试申请单Test Request Form5.2 测试报告（FN-QA-033尺寸报告、FN-QA-034功能报告）5.3 FN-QA-028 实验室温湿度控制记录表5.4 FN-QA-021 专用测量仪器点检表5.5 FN-QA-032 量产产品标准样件清单5.6 FN-QA-024 试验设备能力一览表5.7 FN-QA

4、-019检具日常点检表6.0 RESPONSIBILITY职责6.1 Lab test technician take charge of test and inspect and issue test report; Maintain test instruments and lab environment. 实验室技术员负责日常试验和检测，作好记录并发处测试报告；仪器设备的日常维护、环境条件的保持。6.2 Lab test technician make test instruction ，Quality Manage review test report.实验室技术员负责制定测试操作指导

5、书，提交质量经理审核测试报告。6.3 Storage and management of the laboratory test samples, the customer samples and the limits samples实验室测试样品、客户样品、限度样品等存储及管理。7.0 PROCESS 流程7.1 Lab test scope实验室测试范围Lab test technician make test instruments and review test scope, including test item, test equipments, operation instruc

6、tion and test standard. And establish FN-QA-024< List of test equipment capacity >.实验室技术员制定测试操作指导书，确认实验室的测试项目、测试设备、操作文件、测试标准等，并建立FN-QA-024试验设备能力一览表。7.2 Qualifications and Training of Lab test technician实验室测试人员资格要求Lab test technician should be trained by internal or external on the operation of

7、 testing equipments and test steps, could operate the testing equipments with skill. 实验室测试技术员应经过公司内部或外部的测试设备操作、测试流程的培训，且能熟练操作实验室各种检测和试验设备。7.3 Cycle test plan周期性测试计划Lab test technician make cycle test plan according to control plan and inspection instruction, and get approve from Quality Manager.实验室测

8、试技术员根据控制计划或检验规范等要求，制定周期性测试计划，经质量经理批准后实施。7.4 Test flow实验流程7.4.1 For QC routine test, Lab test technician conduct the test according to the requirements。日常QC的测试，实验室技术员协助QC进行相关项目的测试。7.4.2 For the sample test and other test, related department fill in FN-QA-023 <Test Request> with part no., test i

9、tem and test requirements to lab with samples. If there are special test requirements, the test standard should be provided. 对于样品或周期性检测，需求部门填写FN-QA-023测试申请单，填写相关信息，如料号、实验项目、实验要求，如有特殊测试要求，请提供相应的测试标准。然后将测试申请单与样品一起递交给实验室测试人员。7.4.3 Lab test technician conduct the test based on the test request and WI an

10、d fill in the test report. After get approval from lab supervision, test technician send the samples and test report to the department, and keep soft copy.实验室技术员根据测试要求和作业指导书进行相应测试，填写测试报告，经质量经理审核后将样品与测试报告发给需求部门，测试报告保存电子档。7.4.4 Where customer requires the test data, the appropriate statistical techniq

11、ues application will be stated in the WI.实验室技术员在产品、材料试验过程中可根据实际的工作需要选择以上适当的统计技术方法对产品、材料试验后的各种原始试验数据和结果进行统计工作。7.4.5 If lab cant conduct the test required by customer or relating parties, Lab test technician should ask external laboratory to do the test, which is acceptable by the customer or the labo

12、ratory is accredited to ISO/IEC 17025 or national equivalent. nd keep the ISO/IEC17025 from external laboratory of national accredited实验室无法承担的试验项目，若客户及相关部门有要求，应委托有资质的外部实验室进行试验，外部实验室须被客户认可的或通过ISO/IEC17025 认证合格或国家同等标准认可。并保持对外部实验室获得此相关资质的证明文件7.4.6 management of the Laboratory samples 实验室样品管理 7.4.6.1 Ea

13、ch functional departments according to the technical requirements, fill in the FN-QA-023 <Test Request> and test samples together to the laboratory. Laboratory test samples and identify of according to the FN-QA-023 <Test Request>.各职能部门根据技术要求，认真填写FN-QA-023测试申请单与测试样品一并交至实验室。实验室根据FN-QA-023

14、测试申请单对测试样品测试并标识。7.4.6.2实验室在接收限度样品时，应对样品进行编号，挂上识别标签，注明样品的状态等信息，放置于样品架上。7.4.6.3实验室在接收量产样件时，提交样品部门相应提交样件报告付本，以便与样品一起存档。对样品进行编号，挂上识别标签，注明样品的状态等信息并进行，放置于样品架上。样品保留至下次年度测试时更换。相关信息登记于FN-QA-032量产产品标准样件清单上。7.5 Laboratory routine management 实验室日常管理7.5.1 Test lab technician is responsible for test equipment reg

15、ular maintenance, and fill check sheet FN-QA-021<testing equipment checklist> . For the check fixtures in using, need to check daily. And for the fixtures on the shelf, weekly check is required. All the check for check fixtures goes to FN-QA-019<check fixture daily checklist>实验室技术员负责实验室测

16、试设备的定期维护点检，填写FN-QA-021专用仪器点检表;现在正在使用中的检具，检验员每天使用前对其进行点检，其中如长时间不使用的检具，可每周进行一次点检，填写FN-QA-019检具日常点检表7.5.2 Laboratory environmental Condition shall be controlled at temperature 20±5,Relative Humidity: 60±20 %. Lab test technician check the condition and make FN-QA-028 <Laboratory Environmental Record> every day.为确保测试结果的准确性，实验室的环境温度控制在20±5，湿度40%-80%内。实验室技术员每天检查实验室的环境状态，并填写 FN-QA-028实验室环境记录表。7.5.3 Lab test technician is responsible for 5S in the lab. 实验室技术员负责实验室的日常5S工作。8.0 FLOW CHART