CGMP文件文件印制、分發(fā)、保管、收回、銷毀、撤銷SOP

1、 文件題目Document Title文件印制、發(fā)放、保管、收回、銷毀SOPSOP - Printing, delivery, filing, recalling and destruction of documents文件編號(hào)Document Code文件版本號(hào)Version Code00 (2011)文件種類Category of Document管理類Management發(fā)放部門Department of IssueQA 人員 Person類別 Category姓名/職位Name /Position簽名Signature日期Date編寫人Compiled by審核人Check by批準(zhǔn)人

2、Approved by生效日期Valid from文件分發(fā)部門：（ ）Department of document distributed:序號(hào)Serial No.部門名稱Department Name房間號(hào)Room No.負(fù)責(zé)人Manager12345678910文件變更歷史：History of document changing:版本號(hào)Version Code變更日期Changing Date變更內(nèi)容摘要Abstract of Changing Contents00 (2011)2011.05.16建立文件 File foundation1. SOP的目的 Aim 建立GMP文件的復(fù)制、

3、分發(fā)、保管、收回、銷毀、撤銷程序，使文件保管和使用規(guī)范化。The purpose of this SOP is to define an appropriate procedure for the printing, delivery, keeping, recalling, destruction and revocation of documents, in order to standardize keeping and using of documents.2. 范圍 Scope 所有GMP文件的復(fù)制、分發(fā)、保管、收回、銷毀、撤銷管理過(guò)程。The SOP must be applied

4、 to the printing, delivery, keeping, recalling, destruction and revocation of all the GMP-related documents at Huiyu.3. SOP的內(nèi)容 Content of Standard Operating Procedure3.1 復(fù)印/分發(fā)/收回 Printing/delivery/recalling公司GMP文件由QA部進(jìn)行管理，任何部門不得私自復(fù)印。若發(fā)生以下情況需要使用文件的復(fù)印件，須由使用部門填寫文件復(fù)印申請(qǐng)表（見(jiàn)附錄1）向QA部提出申請(qǐng)，由QA負(fù)責(zé)人批準(zhǔn)，交付文件管理QA進(jìn)行

5、復(fù)印、分發(fā)。GMP documents are managed by QA department, and no another department shall copy without permission. In case of the following condition to copy the documents, the use department s apply to QA department by filling out the "Application for Document Copy "(see Annex 1). After approving

6、 by the head of QA, the application should be delivered to document manage QA for document copying and distribution.3.1.1 新編文件復(fù)印、分發(fā) Copying and distribution of new documents 新編文件生效后，由文件管理QA根據(jù)根據(jù)文件首頁(yè)所示的發(fā)放部門確定需復(fù)印的份數(shù)，并親自負(fù)責(zé)復(fù)印。復(fù)印件應(yīng)能清晰可辨，復(fù)印過(guò)程中作廢的文件應(yīng)即時(shí)銷毀。復(fù)印結(jié)束后必需在原件及復(fù)印文件的每一頁(yè)上加印“GMP批準(zhǔn)文件”。Document manage QA mu

7、st define how many copies has to be printed off according to the number of related-departments described in the first page of the document, and copy the document personally after the document take into force. Copies must be clear and distinguishable and the obsolete paper should be destroyed immedia

8、tely. The copies and the original document must be stamped “Approved GMP document” on each page. 文件管理QA逐部門到現(xiàn)場(chǎng)發(fā)放復(fù)印并蓋章的新編文件。發(fā)放新編文件同時(shí)，文件發(fā)放和接收人應(yīng)完成文件控制單（見(jiàn)附錄2）。Document manage QA must deliver newly updated stamped document copies to each department personally .At the same time, both document suppliers and

9、 receivers should accomplish “Document Control Records “(see Annex 2).所有文件控制單應(yīng)按文件編號(hào)分類保存于QA部文件資料室，在后續(xù)的文件管理程序中亦將使用此單。All “Document Control Records “should be classified by documents numbers and stored in the QA document room, it will also be used in the follow-up document management procedures.3.1.2 修

10、訂文件的復(fù)印、發(fā)放、收回 Printing ,delivery and calling of revised documents經(jīng)過(guò)變更控制SOP（編碼： ）程序修訂的文件，確定生效后，應(yīng)由文件管理QA使用原件根根據(jù)文件首頁(yè)所示的發(fā)放部門進(jìn)行復(fù)印，復(fù)印件應(yīng)能清晰可辨，復(fù)印過(guò)程中作廢的文件應(yīng)即時(shí)銷毀。復(fù)印結(jié)束后必需在原件及復(fù)印文件的每一頁(yè)上加印“GMP批準(zhǔn)文件”。Revised documents on the basis of the procedure " SOP - Change control Procedures"(code: ), if once determin

11、ed to the entry into force, shall be printed out by document manage QA according to the receiving departments on the first page of the original document, and copies should be legible, the obsoleted papers in the process of copying should be destroyed immediately. After copying, its necessary to stam

12、p "GMP approval documents" on and each page of originals and copies.文件管理QA根據(jù)上一版本的文件控制單（見(jiàn)附錄2）到各部門將現(xiàn)場(chǎng)使用的舊版本文件收回，領(lǐng)、發(fā)雙方應(yīng)辦理文件交接手續(xù)，填寫文件控制單，對(duì)收回的原有文件，應(yīng)核實(shí)收回文件名稱、數(shù)量是否與原文件發(fā)放登記記錄相符。如有不符或遺失應(yīng)由文件管理員和當(dāng)事人雙方共同查明不符或遺失原因，并在文件控制單的備注中進(jìn)行登記。Recall the previous version of the documents according to “Document Contr

13、ol Records “(see annex 2)of last version, Receiver and suppliers have to transact document handover procedures, fill the “Document Control Records “, and check the name and quantity of documents to see to that recalled original match with original document delivery records. If it does not comply wit

14、h delivery record or there is loss, the document manages QA and the related person must investigate the reason and recorded at remarks of “Document Control Records “.收回的文件應(yīng)包括現(xiàn)場(chǎng)文件、崗位張貼文件、培訓(xùn)文件以及空白記錄。外發(fā)文件因無(wú)法收回，故不包括在內(nèi)。確認(rèn)丟失的文件亦不在收回之列。均應(yīng)在文件控制單中備注清楚。The recalled documents should include on-site documents,

15、post posted documents, training documents and blank records. Documents could not be recovered because of Dispatch of the document, so it is not included. Confirmatively Lost documents are also out of list. It should be noted clearly in the "Document Controlled record" .文件管理QA收回舊版本文件后，將新版本文

16、件按文件第一頁(yè)的發(fā)放部門進(jìn)行發(fā)放。領(lǐng)、發(fā)雙方應(yīng)辦理文件交接手續(xù)，填寫該文件編號(hào)對(duì)應(yīng)的新的文件控制單。新的文件控制單應(yīng)替換舊的文件控制單，舊版本的文件控制單則作為部門管理記錄保存于QA部文件資料室。After recalling the older version documents, document manage QA deliver the new version ones according to delivering department on the first page. Receiver and suppliers have to transact document handov

17、er procedures, fill the "Document Controlled record" corresponding to the document codes. New "Document Controlled record" replaces old ones. Old version "Document Controlled record" is stored as a department management document in the QA document room.3.1.3 崗位張貼文件復(fù)印、發(fā)放

18、 Printing and delivery of Post posted documents部門崗位張貼類文件劃分，車間，需張貼設(shè)備技術(shù)手冊(cè)、設(shè)備清洗SOP，崗位清場(chǎng)SOP和崗位操作SOP；QC部需張貼技術(shù)手冊(cè)，倉(cāng)庫(kù)需張貼物料SOP，設(shè)備部需張貼技術(shù)手冊(cè)和維護(hù)保養(yǎng)SOP。The department post posted documents classify to: The equipment in workshop, must post the equipment technical manual, the equipment cleaning SOP, the post cleanin

19、g SOP and the post operation SOP; QC must post the technical manual; The warehouse must post material SOP; The equipment department must post the technical manual and the maintenance SOP. 由文件使用部門填寫文件復(fù)印申請(qǐng)表（見(jiàn)附錄1）向QA部提出申請(qǐng)，經(jīng)QA負(fù)責(zé)人批準(zhǔn)，交付文件管理QA進(jìn)行使用文件原件進(jìn)行復(fù)印。并于復(fù)印件的第一頁(yè)上加蓋“崗位文件”章，簽署復(fù)印理由以及總頁(yè)數(shù)。發(fā)放時(shí)，發(fā)、領(lǐng)雙方在文件控制單（見(jiàn)附錄

20、2）上進(jìn)行登記，并注明發(fā)放原因。The departments using documents should fill out the "Application for Document Copy"(see annex 1) to QA department, after the head of QA approves and deliver to document manage QA uses the original documents for copying. On the first page of copy stamp the "Post Documen

21、t" seals, sign in the reasons to copy and the total number of pages. When delivering, receiver and suppliers should register in in the "Document Control records"(see annex 2) and indicate the reason of delivery.3.1.4 培訓(xùn)文件復(fù)印、發(fā)放 Copying and delivering of training documents由培訓(xùn)組向填寫文件復(fù)印申請(qǐng)表

22、（見(jiàn)附錄1）向QA部提出申請(qǐng)，經(jīng)QA負(fù)責(zé)人批準(zhǔn)，交付文件管理QA進(jìn)行使用文件原件進(jìn)行復(fù)印。文件管理QA在復(fù)印件每一頁(yè)上蓋上“僅供培訓(xùn)”印章后發(fā)放給培訓(xùn)管理員，并在對(duì)應(yīng)的文件控制單（見(jiàn)附錄2）進(jìn)行登記，注明發(fā)放原因。The training group fills out the "Application for Document Copy "(see annex1) to QA department, after the head of QA approves and deliver to document manage QA uses the original docum

23、ents for copying. On the first page of copy stamp the "only for training" seals, then deliver it to training administers, register in in the "Document Control records"(see annex 2) and indicate the reason of delivery.培訓(xùn)管理員收到培訓(xùn)文件后按員工培訓(xùn)、考核管理SOP（編碼： ）中的規(guī)定將培訓(xùn)文件發(fā)放給各部門，供現(xiàn)場(chǎng)培訓(xùn)使用。After re

24、ceiving training documents, training administers deliver it to all departments to for on-site training according to “SOP -Training and examination of employees” (Code: ).培訓(xùn)結(jié)束之后，各部門將培訓(xùn)資料與培訓(xùn)文件交回給培訓(xùn)組保存，供新員工培訓(xùn)或定期培訓(xùn)使用。After training, all training materials and training documents will be returned to the t

25、raining group for saving, they can be used for new staff training or regular training.3.1.5 補(bǔ)發(fā)文件的復(fù)印、發(fā)放 Copying and delivering of reissue documents當(dāng)出現(xiàn)以下情況，應(yīng)由相關(guān)部門填寫文件復(fù)印申請(qǐng)表（見(jiàn)附錄1）向QA部提出申請(qǐng)，經(jīng)QA負(fù)責(zé)人批準(zhǔn)，交付文件管理QA進(jìn)行使用文件原件進(jìn)行復(fù)印、補(bǔ)發(fā)。復(fù)印后應(yīng)在復(fù)印件的每一頁(yè)蓋上“增發(fā)文件”、“補(bǔ)發(fā)文件”或“外發(fā)文件”章，并在對(duì)應(yīng)的文件控制單（見(jiàn)附錄2）進(jìn)行登記。In the following condition

26、s, relevant departments should fill out the "Application for Document Copy "(see annex1) to QA department, after the head of QA approves and deliver to document manage QA uses the original documents for copying and reissue. Each page of the copy must be stamped “Increase Document”, “Reissu

27、e Document” or “Dispatch Document”. And should register in "Document Control sheets "(see annex 2) 3.1.5.1 增加文件發(fā)放部門 Increasing document release department 某部門（車間）原不在發(fā)放范圍內(nèi)，現(xiàn)因工作需要某文件時(shí)，由使用部門可填寫文件復(fù)印申請(qǐng)表，經(jīng)本部門負(fù)責(zé)人和QA負(fù)責(zé)人批準(zhǔn)后，到文件管理QA處辦理增發(fā)手續(xù)，并在對(duì)應(yīng)的文件控制單（見(jiàn)附錄2）中注明增發(fā)。A department (workshop) is originally

28、not within delivery ,but now needs some document because of job demand, this department can fill out the " Application for Document Copy ", after approved by department head and head of QA, transact increasing procedures at document manage QA, and indicate in the original document " D

29、ocument Control sheets ".3.1.5.2 文件損壞 Document Damage當(dāng)文件破損影響使用時(shí)，應(yīng)填寫文件復(fù)印申請(qǐng)表，并在申請(qǐng)理由處填寫損壞原因，經(jīng)本部門負(fù)責(zé)人和QA負(fù)責(zé)人批準(zhǔn)后，到文件管理QA處辦理更新手續(xù)，交回破損文件，補(bǔ)領(lǐng)新文件。文件管理QA將破損文件銷毀，并在原文件文件控制單備注記錄破損。When the document is damaged and affecting usage, related department should fill out the "Application for Document Copy "

30、;, and fill in causes of damage at the application blanks, after the approval of the department heads and head of QA, transact updating procedures at document manage QA, return the damaged document and receive the replacing document. Document manage QA must destroy the damaged document, and recorded

31、 damage in the original document "Document Control Sheets ".3.1.5.3 文件丟失 Document lost當(dāng)受控文件使用人確信將文件丟失時(shí)，應(yīng)填寫文件復(fù)印申請(qǐng)表（見(jiàn)附錄1），并在申請(qǐng)理由處填寫丟失原因，經(jīng)本部門負(fù)責(zé)人和QA負(fù)責(zé)人批準(zhǔn)后，到文件管理QA處辦理重新發(fā)放手續(xù)，并在對(duì)應(yīng)的文件控制單中注明丟失。When users of controlled document assure controlled documents is lost, he/she should fill out the " A

32、pplication for Document Copy ", and fill in causes of lost at the application reason blank, after the approval of the department heads and QA manager, transact re-issuance procedure at Document manage QA and recorded lost in the original document "Document Control Sheets ".朗讀3.1.6 外發(fā)文

33、件復(fù)印、發(fā)放 Copying and delivering of dispatch documents有外發(fā)文件需求的公司內(nèi)某一部門，須填寫文件復(fù)印申請(qǐng)表（見(jiàn)附錄1）經(jīng)部門負(fù)責(zé)人和QA負(fù)責(zé)人批準(zhǔn)，到文件管理QA處辦理外發(fā)手續(xù)。文件管理員將文件復(fù)印件加蓋“保密文件章”，與受控文件收據(jù)（見(jiàn)附錄3）一起交申請(qǐng)部門，并填寫文件控制單。Some department which requires document dispatch should firstly fill in "Application for Document Copy ", communicate with doc

34、ument administrator of QA department and follow document reissue procedure after approved by Dept. supervisor and head of QA. Document administrator of QA should hand over the duplicate of the document and “Receipt of Controlled Document” to application department, meanwhile fulfills “Document Contr

35、ol Record”. 該申請(qǐng)部門將文件復(fù)印件與受控文件收據(jù)（見(jiàn)附錄3）一起發(fā)給外發(fā)單位，外發(fā)單位收到后，在受控文件收據(jù)上簽字，并返回QA保存。Application department send the copy of the document dispatched together with “Receipt of Controlled Document”, and the receiving unit signs on “Receipt of Controlled Document” which shall be returned back to QA department and s

36、aved.受控文件收據(jù)應(yīng)作為部門管理記錄由QA文件資料室保存。“Receipt of Controlled Document” should be saved together with the document dispatched.注意事項(xiàng)： Notice:文件控制單（見(jiàn)附錄2）的發(fā)放部門編號(hào)，應(yīng)在每一份復(fù)印件的第一頁(yè)“文件發(fā)放部門”處填寫。編號(hào)方式如下：原件設(shè)定分發(fā)“n”個(gè)部門，則第一個(gè)發(fā)放部門為“1/n”, 第二個(gè)發(fā)放部門為“2/n”，如果依此類推。例如：文件共分發(fā)9個(gè)部門，第一個(gè)部門為QA部，則QA部的復(fù)印文件第一頁(yè)應(yīng)為“1/9”。Delivery departments numbe

37、rs in "Document Control Sheets "(see annex 2), should be written in the " Department of document distributed:" on the first page of each copy. Number as below: Set "n" departments to receive Original documents, so the first delivery department is "1 / n", the

38、second one is "2 / n", and so on. For example: The file is delivered to nine departments, the first one is the QA department, the first page of the QA department's copy should be "1 / 9”.當(dāng)增發(fā)、補(bǔ)發(fā)及外發(fā)文件時(shí)，發(fā)放編號(hào)不在原件上體現(xiàn)，但在文件控制單上應(yīng)有記錄。其編號(hào)應(yīng)按此規(guī)則編制：增加一份文件，其編號(hào)則為“n+1/n”，增加第二份文件，其編號(hào)則為“n+2/n”，依此類推

39、。When there is increasing, replacing and dispatching documents, the release number is not reflected on the original document, but the "Document Control Sheets" must have the proper record. The number should be the preparation of this rule: one document increasing, its number is "n +1

40、/ n", if adding the second one, the release number should be "n +2 / n", and so on.每一份復(fù)印文件的發(fā)放編號(hào)，應(yīng)在復(fù)印后由文件管理QA手寫在該對(duì)應(yīng)的復(fù)印件的第一頁(yè)“文件分發(fā)部門”括號(hào)中，在文件發(fā)放、收回時(shí)，交接雙方應(yīng)對(duì)此編號(hào)進(jìn)行復(fù)核確認(rèn)。雙交接The release number of each document must be hand written in the bracket after “Department of document distributed:” on the

41、 corresponding copys first page after copied by document manage QA. The releaser and receiver should double check this number when handing over the document.3.2 保管 Saving3.2.1 QA部 QA departmentQA部必須設(shè)文件管理QA，由專人負(fù)責(zé)管理文件。文件管理QA負(fù)責(zé)質(zhì)量體系文件具體管理工作。檢查文件是否到位及文件的執(zhí)行情況是QA管理人員及各部門管理人員的共同職責(zé)，此項(xiàng)工作可通過(guò)日常檢查和自檢來(lái)進(jìn)行。There sh

42、ould be specially-assigned document manage QA in QA department responsible for management of document. The document manage QA is responsible for concrete management of quality system document. QA inspector and other departments administers are responsible for checking whether documents in place and

43、implementation is satisfactory by routine inspection and self inspection.文件管理QA于文件控制單（見(jiàn)附錄2）登記后，將文件原件及其文件控制單及相關(guān)文件管理記錄按類歸檔上鎖，只有經(jīng)過(guò)授權(quán)的人才能處理。若為替代文件，將舊版取出，于每一頁(yè)文件右上角加蓋“作廢”印章，封存于QA部。這些失效的文件單獨(dú)放在一個(gè)柜子里，與有效的文件，完全隔離，避免與現(xiàn)行版本混淆使用。這些失效的文件在官員檢查或是產(chǎn)品投訴的時(shí)候可能會(huì)用得上。After document manage QA filled in “Document Controlled S

44、heets”（see annex 2）, file and lock the original document ,its document controlled sheet and related document management records. Finally, these documents must be accessible only for authorised persons. Concerning the amended documents, take out the former edition and stamp“cancellation”on the top ri

45、ght corner, seal up for keeping in QA dept. one of the non - valid documents must be filed in an separated tank (filed them separately from the valid GMP documents). This non - valid version might be necessary or useful at inspections or events like product complaints.QA部負(fù)責(zé)確認(rèn)/驗(yàn)證方案及報(bào)告的審核和保管，確認(rèn)/驗(yàn)證方案及報(bào)

46、告應(yīng)盡量裝訂成冊(cè)，集中管理。QA Department is responsible for checking and saving the validation / validation plan and report. The validation/validation plan and report should be bound, and centralized management.QA部負(fù)責(zé)對(duì)供應(yīng)商資料、審計(jì)報(bào)告、年度產(chǎn)品回顧資料等本部門的管理資料進(jìn)行保管及審核，并對(duì)本部門的管理記錄進(jìn)行保管。QA department is responsible for checking and

47、 saving the suppliers data, audit reports, annual product review and the management data of department. QA department is also responsible for saving of the management records.QA部負(fù)責(zé)對(duì)外來(lái)文件進(jìn)行管理。對(duì)于外來(lái)文件，QA部收到并做登記后，根據(jù)文件內(nèi)容確定發(fā)放范圍進(jìn)行復(fù)印發(fā)放，并進(jìn)行登記。外來(lái)文件原件保存在QA部。Where foreign documents involved, quality department s

48、hould receive and register them, then determine dispensed scope and dispense exact copies. The original copy of foreign document should be saved in QA department.3.2.2 各部門 Deparments各部門負(fù)責(zé)對(duì)本部門的現(xiàn)場(chǎng)文件進(jìn)行保管和維護(hù)。各部門所使用的現(xiàn)場(chǎng)文件，必須是由QA部分發(fā)的有效版本的、印有“GMP批準(zhǔn)文件”紅章的文件。如是增發(fā)、補(bǔ)發(fā)文件則該“GMP批準(zhǔn)文件”章為黑色復(fù)印章，并應(yīng)每一頁(yè)上同時(shí)有“增發(fā)文件”或“補(bǔ)發(fā)文件“紅

49、章。The departments are responsible for the saving and maintenance of site document. The site documents used by departments must be the valid version printed with "GMP approval document" red stamp released by QA department. If it is increase or reissue document, the "GMP approval docume

50、nt" should be black copy, and there must be “Increase Document” or “Reissue Document” red stamp on each page at the same time.現(xiàn)場(chǎng)文件應(yīng)用適當(dāng)?shù)奈募A進(jìn)行整理后，按要求妥善保存于相應(yīng)的房間，不得隨意復(fù)印、借閱、涂改和損壞。不得在工作現(xiàn)場(chǎng)出現(xiàn)非許可復(fù)印文件、舊版文件。Site documents should be appropriate saved in corresponding room after clear up with appropriate fo

51、lder and not to copy, borrow, alter and damage. Non-valid copy, old version copy of document must not appear in operation location.各部門崗位張貼類文件，必須是GMP原件有效版本的復(fù)印件，印有“崗位文件”紅章并寫明復(fù)印用途的文件。The department post posts must be the copy of original GMP document with “Post Document” red stamp and use.崗位張貼類文件必須放置于相

52、應(yīng)的崗位，供崗位人員使用。如在潔凈區(qū)內(nèi)，應(yīng)進(jìn)行過(guò)塑處理，避免產(chǎn)塵。The department post posts must be located in corresponding post for the using of post operators. If it is located in clean area, it should be over plastic to avoid produce dust.文件持有人應(yīng)做好文件維護(hù)工作，保持文件的完好、無(wú)損，積極配合文件管理QA做好文件發(fā)放、收回工作。當(dāng)人員調(diào)崗或調(diào)離、辦理相關(guān)手續(xù)時(shí)，應(yīng)向文件管理員交清有關(guān)文件，文件管理員應(yīng)仔細(xì)核對(duì)文

53、件內(nèi)容、數(shù)量并簽署意見(jiàn)后，廠辦才能辦理調(diào)崗或調(diào)離廠手續(xù)。對(duì)于遺失文件者，必須闡明原因，追查到底，嚴(yán)格防止文件外泄。Document holders should keep documents in good condition and actively cooperate with document manage QA to distribute and recall documents. When employee changing post or leaving, they must send back the related documents to file manager. File

54、 manager must check the contents and quantity of the documentations then sign his / her statement. Then the office can transact related procedure. If it does not comply with delivery record or there is loss, file manager and the person concerned must investigate the reason and record in losing and d

55、efective documents register form.各部門需建立文件和記錄的清單，便于管理。A list of documents and records should be established by related department for convenience for management.文件不得隨意向與執(zhí)行和管理文件無(wú)關(guān)的人員借閱。如確需借閱已歸檔文件，應(yīng)由文件發(fā)放部門向外借閱,借閱人需及時(shí)填寫文件借閱申請(qǐng)書（見(jiàn)附錄4），并做到紙質(zhì)版文件不得復(fù)印，文件管理QA應(yīng)按期催還，以防止文件丟失或損壞。電子版文件嚴(yán)格做好保密工作。The borrower should f

56、ill the sheet of "Application of Document Borrowing"(Annex 4)if the borrowed document have been filed.Document should not be copied and must be returned at the the same day, document manage QA should urge to return the document. The electronic version of document should not be leaked out.3.3 文件銷毀 Destroying of document3.3.1 對(duì)于超過(guò)保存期的文件，由文件管理QA填寫文件銷毀申請(qǐng)表（見(jiàn)附錄5）經(jīng)QA部經(jīng)理及主管領(lǐng)導(dǎo)批準(zhǔn)后由文件管理QA在其它QA的監(jiān)督下銷毀，銷毀后應(yīng)完成文件控制單（見(jiàn)附錄2）中的銷毀記錄。If there are some documents that have exceeded their retention period, the document manage QA must fill in Application for Destructi