交接文件國際項(xiàng)目相關(guān)ument control

1、Control文件控制Tony Chan, PhD, Professor- 教授，博士生導(dǎo)師July 20152015年7月Quality System質(zhì)量體系文件Quality Manual質(zhì)量手冊(cè)Quality procedures (SOPs)質(zhì)量程序（標(biāo)準(zhǔn)操作程序）Forms表格sSOPs related toControl文件控制相關(guān)的標(biāo)準(zhǔn)操作程序Creation, Review, and Approval ProNews;新文件的創(chuàng)立、審核與批準(zhǔn)流程；Change Control Pro文件更改控制流程；s;Master File and Index Maenance Pros;文

2、件主文檔和索引目錄流程；Record Review Pro審核流程；s;Record Change Control Pro更改控制流程；以及s; andRecord Retention, Storage, Retrieval, and Destruction Pros.保留、檢索及銷毀流程。Suggested Elements for SOP標(biāo)準(zhǔn)操作程序中建議出現(xiàn)的元素Title 標(biāo)題 Concise; descriptive 簡明、描述性的語言Waterbath temperature monitoring procedure水浴溫度e 目的程序PurThis procedure provi

3、des instructions for.本程序提供有關(guān)的指導(dǎo)。Procedure instructions 程序說明s 相關(guān)文件參考文獻(xiàn)RelatedReferen Appendients (ex. forms) 附錄或附件（如表格等）or attaAuthors 作者Approval signatures 批準(zhǔn)人簽名History 修改歷史ReviMaster File文件主文檔“Offimadel” copy from which working copies are用以復(fù)印制作工作文件的“正式”版本Contains all previous ver包含之前所有版本的文件s ofMast

4、er Index主目錄s currently in useLists all所有正在使用的文件At a minimum, the elements of the master index need toincludenumber and ver of thename and effective date, the, and the locations of each working copy.在最低程度上，主目錄應(yīng)包含文件名稱和生效日期、文件編碼和版本，以及該文件的每份復(fù)印件的保存地點(diǎn)。 The master index provides laboratory staff with the m

5、eans toidentify the most current verof the. Whenever, updateais changed and updated to a new verthe master index.主目錄應(yīng)為員工提供找出版本文件的方法。當(dāng)一份文件出現(xiàn)修改或更新到新版本的時(shí)候，應(yīng)同時(shí)更新主目錄。Question 1問題1Q. Should QC instructions be included in aprocedure?問題：質(zhì)控說明是否應(yīng)該包含在一個(gè)程序文件中。Question 2問題2Q. You are writing a proceduret will sp

6、ecifythe desired reaction temperature.What isthe best way to se this?問題：你正在書寫一份需要指定反應(yīng)溫度的程序文件。最佳的說明方式是怎樣的？Question 3問題3Q. You are writing a procedure for the format of SOPs?You want to specifyt each page be numbered, soyou write the following:問題：你正在為SOP的制作格式書寫一個(gè)程序文件。你想要指明文件中的每一頁都應(yīng)有編碼。所以，你寫下了以下內(nèi)容：Each page must be numbered sequentiallyhelower righpage x of y.nd corner of the page using the format每一頁都應(yīng)在右下角以“第X頁共y頁”的格式按序Is this good or bad?這樣寫合不合適？。Question 4問題4In a procedure such as aQ.approva