Laboratory management实验室管理程序(中英文).docx
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1、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2.02020-10-31保持外部实验室资质证明1.0 PURPOSE 目的1.1 This document defines the management regulation for the laboratory and ensures that thesystem is effective and the quality of tests and calibration results are valid.定义
2、实验室管理规范,保证测试的有效性。2.0SCOPE 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活动的管理。3.0 DEFINITIONS 定义None 无4.0 REFERENCE DOCUMENTS 参考文件4.1 IATF16949 Clause 7.6.3 - 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-
3、034功能报告)5.3 FNQA-028实验室温湿度控制记录表5.4 FNQA021专用测量仪器点检表5.5 FNQA032量产产品标准样件清单5.6 FNQA-024试验设备能力一览表5.7 FN-QA-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 testinstruments 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
4、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 limitssamples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
5、 make test instruments and review test scope, including test item, testequipments, operation instruction and test standard. And establish FN-QA-024.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 s
6、hould be trained by internal or external on the operation of testingequipments 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 inspect
7、ion instruction, andget approve from Quality Manager.实验室测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 requirementSo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 fil
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