Laboratory management Procedure 實(shí)驗(yàn)室管理程序（中英版）

1、QUALITY SYSTEM PROCEDURE 質(zhì) 量 體 系 程 序Number 文件編號(hào):PD-S3-02Department 部門(mén):QA 質(zhì)量部 Subject 文件名稱:Laboratory management Procedure 實(shí)驗(yàn)室管理程序Revision版本: 2.0Effective Date生效日期:2012-10-31Page 4 of 4批準(zhǔn)：審核：作成：Change History變更記錄Revision 版本Effective Date生效日期Originator編寫(xiě)人Reasons for Change修改原因2.02012-10-31Sandy He保持外部

2、實(shí)驗(yàn)室資質(zhì)證明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.定義實(shí)驗(yàn)室管理規(guī)范，保證測(cè)試的有效性。2.0 SCOPE 范圍2.1 Apply to the people activities and test in the laboratory. 適用于對(duì)實(shí)驗(yàn)室人員和相關(guān)實(shí)驗(yàn)

3、活動(dòng)的管理。3.0 DEFINITIONS定義None 無(wú)4.0 REFERENCE DOCUMENTS參考文件4.1 ISO/TS 16949 Clause Laboratory requirements 實(shí)驗(yàn)室要求5.0 RECORDS 記錄5.1 FN-QA-023 測(cè)試申請(qǐng)單Test Request Form5.2 測(cè)試報(bào)告（FN-QA-033尺寸報(bào)告、FN-QA-034功能報(bào)告）5.3 FN-QA-028 實(shí)驗(yàn)室溫濕度控制記錄表5.4 FN-QA-021 專用測(cè)量?jī)x器點(diǎn)檢表5.5 FN-QA-032 量產(chǎn)產(chǎn)品標(biāo)準(zhǔn)樣件清單5.6 FN-QA-024 試驗(yàn)設(shè)備能力一覽表5.7 FN-QA

4、-019檢具日常點(diǎn)檢表6.0 RESPONSIBILITY職責(zé)6.1 Lab test technician take charge of test and inspect and issue test report; Maintain test instruments and lab environment. 實(shí)驗(yàn)室技術(shù)員負(fù)責(zé)日常試驗(yàn)和檢測(cè)，作好記錄并發(fā)處測(cè)試報(bào)告；儀器設(shè)備的日常維護(hù)、環(huán)境條件的保持。6.2 Lab test technician make test instruction ，Quality Manage review test report.實(shí)驗(yàn)室技術(shù)員負(fù)責(zé)制定測(cè)試操作指導(dǎo)

5、書(shū)，提交質(zhì)量經(jīng)理審核測(cè)試報(bào)告。6.3 Storage and management of the laboratory test samples, the customer samples and the limits samples實(shí)驗(yàn)室測(cè)試樣品、客戶樣品、限度樣品等存儲(chǔ)及管理。7.0 PROCESS 流程7.1 Lab test scope實(shí)驗(yàn)室測(cè)試范圍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 >.實(shí)驗(yàn)室技術(shù)員制定測(cè)試操作指導(dǎo)書(shū)，確認(rèn)實(shí)驗(yàn)室的測(cè)試項(xiàng)目、測(cè)試設(shè)備、操作文件、測(cè)試標(biāo)準(zhǔn)等，并建立FN-QA-024試驗(yàn)設(shè)備能力一覽表。7.2 Qualifications and Training of Lab test technician實(shí)驗(yàn)室測(cè)試人員資格要求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. 實(shí)驗(yàn)室測(cè)試技術(shù)員應(yīng)經(jīng)過(guò)公司內(nèi)部或外部的測(cè)試設(shè)備操作、測(cè)試流程的培訓(xùn)，且能熟練操作實(shí)驗(yàn)室各種檢測(cè)和試驗(yàn)設(shè)備。7.3 Cycle test plan周期性測(cè)試計(jì)劃Lab test technician make cycle test plan according to control plan and inspection instruction, and get approve from Quality Manager.實(shí)驗(yàn)室測(cè)

8、試技術(shù)員根據(jù)控制計(jì)劃或檢驗(yàn)規(guī)范等要求，制定周期性測(cè)試計(jì)劃，經(jīng)質(zhì)量經(jīng)理批準(zhǔn)后實(shí)施。7.4 Test flow實(shí)驗(yàn)流程7.4.1 For QC routine test, Lab test technician conduct the test according to the requirements。日常QC的測(cè)試，實(shí)驗(yàn)室技術(shù)員協(xié)助QC進(jìn)行相關(guān)項(xiàng)目的測(cè)試。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. 對(duì)于樣品或周期性檢測(cè)，需求部門(mén)填寫(xiě)FN-QA-023測(cè)試申請(qǐng)單，填寫(xiě)相關(guān)信息，如料號(hào)、實(shí)驗(yàn)項(xiàng)目、實(shí)驗(yàn)要求，如有特殊測(cè)試要求，請(qǐng)?zhí)峁┫鄳?yīng)的測(cè)試標(biāo)準(zhǔn)。然后將測(cè)試申請(qǐng)單與樣品一起遞交給實(shí)驗(yàn)室測(cè)試人員。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.實(shí)驗(yàn)室技術(shù)員根據(jù)測(cè)試要求和作業(yè)指導(dǎo)書(shū)進(jìn)行相應(yīng)測(cè)試，填寫(xiě)測(cè)試報(bào)告，經(jīng)質(zhì)量經(jīng)理審核后將樣品與測(cè)試報(bào)告發(fā)給需求部門(mén)，測(cè)試報(bào)告保存電子檔。7.4.4 Where customer requires the test data, the appropriate statistical techniq

11、ues application will be stated in the WI.實(shí)驗(yàn)室技術(shù)員在產(chǎn)品、材料試驗(yàn)過(guò)程中可根據(jù)實(shí)際的工作需要選擇以上適當(dāng)?shù)慕y(tǒng)計(jì)技術(shù)方法對(duì)產(chǎn)品、材料試驗(yàn)后的各種原始試驗(yàn)數(shù)據(jù)和結(jié)果進(jìn)行統(tǒng)計(jì)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實(shí)驗(yàn)室無(wú)法承擔(dān)的試驗(yàn)項(xiàng)目，若客戶及相關(guān)部門(mén)有要求，應(yīng)委托有資質(zhì)的外部實(shí)驗(yàn)室進(jìn)行試驗(yàn)，外部實(shí)驗(yàn)室須被客戶認(rèn)可的或通過(guò)ISO/IEC17025 認(rèn)證合格或國(guó)家同等標(biāo)準(zhǔn)認(rèn)可。并保持對(duì)外部實(shí)驗(yàn)室獲得此相關(guān)資質(zhì)的證明文件7.4.6 management of the Laboratory samples 實(shí)驗(yàn)室樣品管理 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>.各職能部門(mén)根據(jù)技術(shù)要求，認(rèn)真填寫(xiě)FN-QA-023測(cè)試申請(qǐng)單與測(cè)試樣品一并交至實(shí)驗(yàn)室。實(shí)驗(yàn)室根據(jù)FN-QA-023

14、測(cè)試申請(qǐng)單對(duì)測(cè)試樣品測(cè)試并標(biāo)識(shí)。7.4.6.2實(shí)驗(yàn)室在接收限度樣品時(shí)，應(yīng)對(duì)樣品進(jìn)行編號(hào)，掛上識(shí)別標(biāo)簽，注明樣品的狀態(tài)等信息，放置于樣品架上。7.4.6.3實(shí)驗(yàn)室在接收量產(chǎn)樣件時(shí)，提交樣品部門(mén)相應(yīng)提交樣件報(bào)告付本，以便與樣品一起存檔。對(duì)樣品進(jìn)行編號(hào)，掛上識(shí)別標(biāo)簽，注明樣品的狀態(tài)等信息并進(jìn)行，放置于樣品架上。樣品保留至下次年度測(cè)試時(shí)更換。相關(guān)信息登記于FN-QA-032量產(chǎn)產(chǎn)品標(biāo)準(zhǔn)樣件清單上。7.5 Laboratory routine management 實(shí)驗(yàn)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>實(shí)驗(yàn)室技術(shù)員負(fù)責(zé)實(shí)驗(yàn)室測(cè)

16、試設(shè)備的定期維護(hù)點(diǎn)檢，填寫(xiě)FN-QA-021專用儀器點(diǎn)檢表;現(xiàn)在正在使用中的檢具，檢驗(yàn)員每天使用前對(duì)其進(jìn)行點(diǎn)檢，其中如長(zhǎng)時(shí)間不使用的檢具，可每周進(jìn)行一次點(diǎn)檢，填寫(xiě)FN-QA-019檢具日常點(diǎn)檢表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.為確保測(cè)試結(jié)果的準(zhǔn)確性，實(shí)驗(yàn)室的環(huán)境溫度控制在20±5，濕度40%-80%內(nèi)。實(shí)驗(yàn)室技術(shù)員每天檢查實(shí)驗(yàn)室的環(huán)境狀態(tài)，并填寫(xiě) FN-QA-028實(shí)驗(yàn)室環(huán)境記錄表。7.5.3 Lab test technician is responsible for 5S in the lab. 實(shí)驗(yàn)室技術(shù)員負(fù)責(zé)實(shí)驗(yàn)室的日常5S工作。8.0 FLOW CHART