質(zhì)量文件和記錄保留之工作指引-中英文對照

1、TITLE : WORK INSTRUCTION FOR RETENTION OF QUALITY DOCUMENTS AND RECORDS質(zhì)量文件和記錄保留之工作指引Document No.: DC30005Rev. No. :A00Page 1 of 7Revision HistoryREVDCN #INITIATEDBYEFFECTIVEDATE (MM/DD/YY)DESCRIPTIONA00D141606W川iam Magramo04/18/14Initial ReleaseApproved DCN on File in Document ControlAPPROVED BYMot

2、oaki WakuiAUTHORIZED BYSK LamCONFIDENTIALPROPERTY OF ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITEDThis document, and the information it contains, are the property of Zhong shan Sunming Optical Technologies Limited and are protected by law. Both must be held in strict confidence at all times.No lice

3、nse expressed or implied, under any patent, copyright or other intellectualproperty right is granted or implied by the provision or possession of this document. No part ofthis document may be reproduced,transmitted, transcribed, stored in a retrieval system, translated into any language or computer

4、language, in any form or by any means, whatsoever, without the prior written consent ofZhongshan Sunming Optical Technologies Limited.?2014 ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITEDALL RIGHTS RESERVED(Any hard copy print out of this document is uncontrolled unless it bears DCC red controlled st

5、amp)DOC. NO.DC30005REVISIONA00PAGE2 OF 7TITLE: WORK INSTRUCTION FOR RETENTION OF QUALITY DOCUMENTS AND RECORDS 質(zhì)量文件和記錄保留之工作指引SCOPE 范圍This work instruction defines the requirements for the retention of quality documents and records in SUNMING.此工作指引明確了保存在三鳴公司的質(zhì)量文件和記錄之要求。This work instruction shall app

6、ly to quality documents and records generated internally and those received from suppliers and customers.此工作指引應(yīng)用于內(nèi)部產(chǎn)生的以及來自于供應(yīng)商和客商的質(zhì)量文件和記錄。This work instruction also defines the archiving duration and retrieval of quality documents and records.此工作指引也明確了這些質(zhì)量文件和記錄的歸檔時間和檢索。ASSOCIATED DOCUMENTS相關(guān)文件DC2000

7、1 - Document Control Procedure.DC20001 -文件控制程序DC30001 - Work Instruction for Document Numbering.DC30001 -文件編碼之工作指引3.0 GENERAL REQUIREMENTS一般要求DCC is responsible for maintaining archived documents and its disposal based on this work instruction.文控中心應(yīng)根據(jù)此工作指引對歸檔文件進行維護和清理。Records shall be stored in a ma

8、nner whereby the information can be easily retrieved.應(yīng)按照信息易于取回的方式來儲存記錄。Access to archived documents and records shall only be authorized by DCC staff.使用歸檔文件和記錄應(yīng)得到文控中心人員之授權(quán)。Cabinets, boxes and folders containing records shall be clearly labeled indicating the contents of the file.用于保存文件的柜子，箱子和文件夾應(yīng)清楚的

9、標示指明所包含的文件。?2014 ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITEDConfidential(Any hard copy print out of this document is uncontrolled unless it bears DCC red controlled stamp)DOC. NO.DC30005REVISIONA00PAGE3 OF 7TITLE: WORK INSTRUCTION FOR RETENTION OF QUALITY DOCUMENTS AND RECORDS 質(zhì)量文件和記錄保留之工作指引Archi

10、ving of Documents and Records.歸檔文件和記錄On the month of May and October, requesting department shall send Archive Request Form to DCC. The requestor is responsible for providing accurate information of archived documents. This is applicable to both hard copy and soft copy documents. Refer to attachment

11、 1 for Archive Request Form.在五月和十月，申請部門應(yīng)將存檔申請表格發(fā)送給文件控制中心。申請者負責(zé)提供存 檔文件的準確信息。其可同時用于文檔的打印和電子保存。存檔申請表請參考附件1。Requesting departments shall organize documents, records or files by grouping them by type and month.申請部門應(yīng)按類型和月份整理文件，記錄和檔案。Document Control shall maintain a perpetual database or master list of al

12、l archived documents including those destroyed or deleted. The master list shall include folder location or box numbers of documents / records or files on archive.文件控制應(yīng)維持數(shù)據(jù)庫或所有歸檔文件的主列表之永久性，包括那些銷毀或刪除的文件。 主列表應(yīng)包括文件夾位置或文件/記錄/存檔文件的箱號。Documents and Records and their Retention Periods.文件和記錄及其保存期Quality Ass

13、urance Documents and Records.質(zhì)量保證文件和記錄Documents and RecordsRetention Period1.) Management reviews管理評審a.) Minutes of management review meetings 管理評審會議記錄b.) Management review inputs (power point file) 管理評審輸入(PPT文件)c.) Customer satisfaction result客戶滿意度結(jié)果d.) KPI and improvement programs關(guān)鍵業(yè)績指標及提升計劃5 year

14、s5年2.) Results of supplier evaluations results 供應(yīng)商評估結(jié)果a.) QSA and QPA reports / responses.5 years5年?2014 ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITED Confidential(Any hard copy print out of this document is uncontrolled unless it bears DCC red controlled stamp)質(zhì)量體系審查和品質(zhì)制程審查報告/反饋b.) Supplier rating

15、s;供應(yīng)商評級3.) Validation of processes.制程檢驗a.) IQC report.來料檢驗報告b.) IPQC report制程檢驗報告c.) OQC report成品檢驗報告5 years5年4.) Customer property客商資產(chǎn)a.) Customer Documents.客商文件b.) Customer Supplied records.客商提供的記錄5 years5年5.) Internal audit results and follow-up actions 內(nèi)部審查結(jié)果和跟進行動a.) Internal quality audit repor

16、ts.內(nèi)部質(zhì)里申直報告b.) Corrective and Preventive action response. 更止及預(yù)防行動反應(yīng)3 years3年6.) Authorized release of product 授權(quán)的產(chǎn)品a.) MRB reports.材料審核委員會的報告3 years3年7.) Product Non-conformities產(chǎn)品不一致性a.) Customer complains 8D reports.客訴8D報告b.) Customer waivers.客商特米5 years5年8.) Document Control Center Master File文控中

17、心上文件a.) Obsolete revisions of QMS documentation.質(zhì)量管理體系文件之廢棄版本b.) Obsolete revisions of Product documentation.生產(chǎn)文件體系之廢弁版本3 years3年TITLE: WORK INSTRUCTION FOR RETENTION OF QUALITY DOCUMENTS AND RECORDS 質(zhì)量文件和記錄保留之工作指引DOC. NO.REVISIONPAGEDC30005A004 OF 7?2014 ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMIT

18、EDConfidential(Any hard copy print out of this document is uncontrolled unless it bears DCC red controlled stamp)DOC. NO.DC30005REVISIONA00PAGE OF 7TITLE: WORK INSTRUCTION FOR RETENTION OF QUALITY DOCUMENTS AND RECORDS 質(zhì)量文件和記錄保留之工作指引Human Resources Documents and Records.人力力資源文件及記錄Documents and Recor

19、dsRetention Period1.) Education, training, skills and experience 教育，訓(xùn)練，技能及經(jīng)驗a.) Personnel Training records 個人訓(xùn)練記錄b.) Personnel records of experiences 個人經(jīng)驗記錄c.) Personnel records of education attained 個人參加教育記錄Employment + 2 years聘用期+2年Engineering and Production Documents and Records.工程&生產(chǎn)文件和記錄Documen

20、ts and RecordsRetention Period1.) Product realization process results 產(chǎn)品實現(xiàn)制程之結(jié)果a.) Eng g review of Metrics工程評估指標2 years2年2.) Product requirements review results. 產(chǎn)品要求之評審結(jié)果a.) Customer Requirements Review 客戶要求之評估5 years5年3.) Design and development inputs relating to product requirements 與產(chǎn)品要求的設(shè)計和發(fā)展有關(guān)

21、的輸入a.) Customer Specifications客商規(guī)格書5 years5年4.) Results of design and development reviews 設(shè)計和發(fā)展評審之結(jié)果a.) Product Development Review Minutes 產(chǎn)品發(fā)展評審記錄5 years5年5.) Results of design and development verification / Validation 設(shè)計和發(fā)展之確認/批準結(jié)果a.) Test report series測試報告系列5 years5年6.) Results of the review of d

22、esign and development changes設(shè)計和發(fā)展變更之評審結(jié)果a.) Engineering Change Notice工程受更通知5 years5年?2014 ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITEDConfidential(Any hard copy print out of this document is uncontrolled unless it bears DCC red controlled stamp)TITLE: WORK INSTRUCTION FOR RETENTION OFD0c. NO.DC30

23、005QUALITY DOCUMENTS AND RECORDSREVISIONA00質(zhì)量文件和記錄保留之工作指引PAGE92工7.) The unique identification of the product and traceability.產(chǎn)品及追溯的唯一標識a.) Baselines基準8 years8年8.) Validity of the previous measuring results on NG gauges 之前儀表測量結(jié)果為NG的正確性a.) Calibration Fail Product Retest檢定失敗的產(chǎn)品重新測試2 years2年9.) Result

24、s of calibration and verification of measuring equipment檢定結(jié)果和測量儀器的檢定a.) Calibration Report檢定報告3 years3年10.) Production documents and records生產(chǎn)義件及記錄5 years5年Archive retrieval request.檔案檢索申請Retrieval of archived documents and records shall be requested through DCC. Approval of the archive retrieval re

25、quest belongs to DCC.應(yīng)通過文控中心申請檔案和記錄檢索。批準檔案檢索之權(quán)利屬于文件控制中心。Archive documents and records can only be copied from its location.Removal from its location is not allowed.文件和記錄檢索只能從存儲單元拷貝，不能移除。Archive disposal檔案?f理；Archived hard copy documents that expires retention period shall be destroyed by DCC in perm

26、anent manner such as shredding.打印文件存檔保存期滿，應(yīng)由文控中心以固定形式銷毀，如撕碎。Archived soft copy files that expires retention period shall be completely deleted from from the archive server.電子保存文件存檔期滿，應(yīng)從伺服器中完全刪除。DCC shall update Archive Document and Records master list to reflect the status of deleted files or destroyed documents and records.?2014 ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITEDConfidential(Any hard copy print out of this