Laboratory management Procedure 實驗室管理程序（中英版）

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

2、實驗室資質(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.定義實驗室管理規(guī)范，保證測試的有效性。2.0 SCOPE 范圍2.1 Apply to the people activities and test in the laboratory. 適用于對實驗室人員和相關(guān)實驗

3、活動的管理。3.0 DEFINITIONS定義None 無4.0 REFERENCE DOCUMENTS參考文件4.1 ISO/TS 16949 Clause Laboratory requirements 實驗室要求5.0 RECORDS 記錄5.1 FN-QA-023 測試申請單Test Request Form5.2 測試報告（FN-QA-033尺寸報告、FN-QA-034功能報告）5.3 FN-QA-028 實驗室溫濕度控制記錄表5.4 FN-QA-021 專用測量儀器點檢表5.5 FN-QA-032 量產(chǎn)產(chǎn)品標準樣件清單5.6 FN-QA-024 試驗設(shè)備能力一覽表5.7 FN-QA

4、-019檢具日常點檢表6.0 RESPONSIBILITY職責6.1 Lab test technician take charge of test and inspect and issue test report; Maintain test instruments and lab environment. 實驗室技術(shù)員負責日常試驗和檢測，作好記錄并發(fā)處測試報告；儀器設(shè)備的日常維護、環(huán)境條件的保持。6.2 Lab test technician make test instruction ，Quality Manage review test report.實驗室技術(shù)員負責制定測試操作指導

5、書，提交質(zhì)量經(jīng)理審核測試報告。6.3 Storage and management of the laboratory test samples, the customer samples and the limits samples實驗室測試樣品、客戶樣品、限度樣品等存儲及管理。7.0 PROCESS 流程7.1 Lab test scope實驗室測試范圍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 >.實驗室技術(shù)員制定測試操作指導書，確認實驗室的測試項目、測試設(shè)備、操作文件、測試標準等，并建立FN-QA-024試驗設(shè)備能力一覽表。7.2 Qualifications and Training of Lab test technician實驗室測試人員資格要求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. 實驗室測試技術(shù)員應(yīng)經(jīng)過公司內(nèi)部或外部的測試設(shè)備操作、測試流程的培訓，且能熟練操作實驗室各種檢測和試驗設(shè)備。7.3 Cycle test plan周期性測試計劃Lab test technician make cycle test plan according to control plan and inspection instruction, and get approve from Quality Manager.實驗室測

8、試技術(shù)員根據(jù)控制計劃或檢驗規(guī)范等要求，制定周期性測試計劃，經(jīng)質(zhì)量經(jīng)理批準后實施。7.4 Test flow實驗流程7.4.1 For QC routine test, Lab test technician conduct the test according to the requirements。日常QC的測試，實驗室技術(shù)員協(xié)助QC進行相關(guān)項目的測試。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. 對于樣品或周期性檢測，需求部門填寫FN-QA-023測試申請單，填寫相關(guān)信息，如料號、實驗項目、實驗要求，如有特殊測試要求，請?zhí)峁┫鄳?yīng)的測試標準。然后將測試申請單與樣品一起遞交給實驗室測試人員。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.實驗室技術(shù)員根據(jù)測試要求和作業(yè)指導書進行相應(yīng)測試，填寫測試報告，經(jīng)質(zhì)量經(jīng)理審核后將樣品與測試報告發(fā)給需求部門，測試報告保存電子檔。7.4.4 Where customer requires the test data, the appropriate statistical techniq

11、ues application will be stated in the WI.實驗室技術(shù)員在產(chǎn)品、材料試驗過程中可根據(jù)實際的工作需要選擇以上適當?shù)慕y(tǒng)計技術(shù)方法對產(chǎn)品、材料試驗后的各種原始試驗數(shù)據(jù)和結(jié)果進行統(tǒng)計工作。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實驗室無法承擔的試驗項目，若客戶及相關(guān)部門有要求，應(yīng)委托有資質(zhì)的外部實驗室進行試驗，外部實驗室須被客戶認可的或通過ISO/IEC17025 認證合格或國家同等標準認可。并保持對外部實驗室獲得此相關(guān)資質(zhì)的證明文件7.4.6 management of the Laboratory samples 實驗室樣品管理 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>.各職能部門根據(jù)技術(shù)要求，認真填寫FN-QA-023測試申請單與測試樣品一并交至實驗室。實驗室根據(jù)FN-QA-023

14、測試申請單對測試樣品測試并標識。7.4.6.2實驗室在接收限度樣品時，應(yīng)對樣品進行編號，掛上識別標簽，注明樣品的狀態(tài)等信息，放置于樣品架上。7.4.6.3實驗室在接收量產(chǎn)樣件時，提交樣品部門相應(yīng)提交樣件報告付本，以便與樣品一起存檔。對樣品進行編號，掛上識別標簽，注明樣品的狀態(tài)等信息并進行，放置于樣品架上。樣品保留至下次年度測試時更換。相關(guān)信息登記于FN-QA-032量產(chǎn)產(chǎn)品標準樣件清單上。7.5 Laboratory routine management 實驗室日常管理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>實驗室技術(shù)員負責實驗室測

16、試設(shè)備的定期維護點檢，填寫FN-QA-021專用儀器點檢表;現(xiàn)在正在使用中的檢具，檢驗員每天使用前對其進行點檢，其中如長時間不使用的檢具，可每周進行一次點檢，填寫FN-QA-019檢具日常點檢表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.為確保測試結(jié)果的準確性，實驗室的環(huán)境溫度控制在20±5，濕度40%-80%內(nèi)。實驗室技術(shù)員每天檢查實驗室的環(huán)境狀態(tài)，并填寫 FN-QA-028實驗室環(huán)境記錄表。7.5.3 Lab test technician is responsible for 5S in the lab. 實驗室技術(shù)員負責實驗室的日常5S工作。8.0 FLOW CHART