風(fēng)險(xiǎn)評(píng)估追溯矩陣（RTM）模板

1、需求追溯矩陣Requirements Traceability Matrix編號(hào) Reference：版本號(hào)Version：工程 Entity:頁(yè)碼 Page ： 1 of 7泡罩包裝機(jī)批準(zhǔn)頁(yè)面Approval Cover Sheet修訂歷史Revision版本號(hào)Rev.日期Date修訂內(nèi)容ModiHcation修訂原因Reason for Revision1/介紹 INTRODUCTION對(duì)每個(gè)相關(guān)的產(chǎn)品屬性及設(shè)備功能的風(fēng)險(xiǎn)分析可通過(guò)回答以下問(wèn)題進(jìn)行：是否與產(chǎn)品直接接觸？其功能是否影響產(chǎn)品質(zhì)量屬性？依靠設(shè)備功能生成的數(shù)據(jù)是否屬于批記錄或其它GMP相關(guān)文件的一局部？這些數(shù)據(jù)是 否用于放行產(chǎn)品？

2、某項(xiàng)功能用于維護(hù)產(chǎn)品質(zhì)量或產(chǎn)品狀態(tài)嗎？某項(xiàng)功能失效影響關(guān)鍵工藝參數(shù)或產(chǎn)品質(zhì)量嗎？如果是，失效是否可以被設(shè)備的其它功 能，或其他系統(tǒng)檢測(cè)到？對(duì)關(guān)鍵工藝參數(shù)的監(jiān)測(cè)是否不再經(jīng)其它質(zhì)量系統(tǒng)的控制？對(duì)于以上6個(gè)問(wèn)題，如果有一個(gè)回答為“是”，該項(xiàng)功能那么需要在確認(rèn)中進(jìn)行檢查/測(cè)試。如果 都是“不適用”，那么無(wú)需進(jìn)行確認(rèn)，但可能在調(diào)試中進(jìn)行測(cè)試。需求追溯矩陣Requirements Traceability Matrix編號(hào) Reference： 版本號(hào)Version： 工程 Entity:頁(yè)碼 Page ： 4 of 7泡罩包裝機(jī)2. 需求追溯矩陣 Requirement Traceability Mat

3、rix廠房設(shè)施/公用工程設(shè)備/系統(tǒng)名稱Facility/Utilities/Equipment System Name泡罩包裝機(jī)追溯矩陣Traceability Matrix是否執(zhí)行序號(hào)Item功能描述Function description功能風(fēng)險(xiǎn)評(píng)估(適用不適用“N/A”)Function Risk Assessment ( for applicable and N/A for not applicable)1234561設(shè)備不高于2.5米，重量小于800kg/平方米。Height of the equipment is not greater than 2.5 meters and we

4、ighing less than 800kg / square meter.N/AN/AN/AN/AN/AN/ASAT口是否2運(yùn)行方式：點(diǎn)動(dòng)、自動(dòng)。 Operating mode: jog, automatic.N/AN/AN/AN/AN/AN/ASAT口是否3除更換鋁箔外，設(shè)備應(yīng)不停機(jī)運(yùn)行。The equipment must run without stopping, except for the Alu foil changing.N/AN/AN/AN/AN/AN/ASAT口是否4適用于包裝1號(hào)和3號(hào)膠囊，也適用于包裝異 形片。3# and 1# size capsule can be

5、packed, Special shape of tablets can be packed with appropriate format tools.N/AqN/AN/AN/AN/AOQ口是口否5使用我司提供的鋁/PVDC,產(chǎn)量不小于300板/ 每分鐘。The capacity of equipment should be not less than 300 blisters per minute with the Alu/PVDC provided by our company.N/AN/AN/AN/AN/AN/AOQ口是否6預(yù)留使用成型材PP的位置。N/AN/AN/AN/AN/AN/A

6、SAT口是口否用戶需求追溯矩陣Requirements Traceability Matrix編號(hào) Reference：版本號(hào)Version：工程 Entity:頁(yè)碼 Page ： 5 of 7廠房設(shè)施/公用工程設(shè)備/系統(tǒng)名稱Facility/Utilities/Equipment System Name泡罩包裝機(jī)追溯矩陣Traceability Matrix是否執(zhí)行序號(hào)Item功能描述Function description功能風(fēng)險(xiǎn)評(píng)估(適用T”，不適用“N/A”)Function Risk Assessment (4 for applicable and N/A for not appli

7、cable)123456The position for forming PP film should be preserved.7開始、停止、復(fù)位、急停等應(yīng)有單獨(dú)的按鈕在 操作面板上，不必受制于觸摸屏，方便操作。Startstopresetexl should be set in respective button in operation panel which are not controlled by touching screen.N/AN/AN/AN/AN/AN/ASAT口是否8帶目視鏡的料斗，料斗最少能容納30分鐘生 產(chǎn)所需物料。A suitable hopper with th

8、e view glass, its volume can hold bulk for 30 minutes packing.N/AN/AN/AN/AN/AN/ASAT口是否9應(yīng)設(shè)置三個(gè)泡罩板收集箱，一個(gè)用于收集空 板，一個(gè)用于含藥廢板，第三個(gè)用于收集好的泡罩板，當(dāng)后 段裝盒機(jī)停機(jī)時(shí)，泡罩板被臨時(shí)收集進(jìn)入該箱。Three bins collecting blisters shall be equipped, one with empty blisters, one with blisters containing some products, The third bin collects tem

9、porarily the good blisters when the link cartoning machine stops accidently.N/AN/AN/AqN/AN/AOQ口是否10批號(hào)信息(含批號(hào)、生產(chǎn)日期和有效期)印制 方式為壓印，兩側(cè)各一行，每行不少于19個(gè)字粒。The batch information (including batch number, MFR and EXP.) should be debossed (imprinted), one line shall be range both two sides, and the letters in each

10、raw is not less than 19N/AN/AqqN/AIQ/ OQ/PQ口是否用戶需求追溯矩陣Requirements Traceability Matrix編號(hào) Reference：版本號(hào)Version：工程 Entity:頁(yè)碼 Page ： 6 of 7廠房設(shè)施/公用工程設(shè)備/系統(tǒng)名稱Facility/Utilities/Equipment System Name泡罩包裝機(jī)追溯矩陣Traceability Matrix是否執(zhí)行序號(hào)Item功能描述Function description功能風(fēng)險(xiǎn)評(píng)估(適用T”，不適用“N/A”)Function Risk Assessment

11、(4 for applicable and N/A for not applicable)123456pieces.11設(shè)備應(yīng)適用于現(xiàn)有包裝材料，包裝材料明細(xì)詳 見附件。Equipment should be applied to existing packaging materials that attached documents in annex.N/AqN/AqN/AN/AOQ/PQ口是否12設(shè)備應(yīng)配備至少以下三個(gè)運(yùn)行指示燈，并在醒 目位置：綠燈：設(shè)備正常狀態(tài)（running）紅燈：設(shè)備故障狀態(tài)，需要操作人員維修檢查或復(fù)位后才可 運(yùn)行（stop）。黃燈:油備狀態(tài)（ready）。Equi

12、pment should be equipped with running lights in prominent position.Green: runningRed: failure, stop, the machine needs to check or reset.Yellow: readyN/AN/AN/AN/AqN/AOQ口是口否13意外斷電及或緊急停機(jī)時(shí)不會(huì)損壞設(shè)備和產(chǎn) 品，數(shù)據(jù)不喪失。When accident or emergency shut down, the equipment and products should not be damaged, data shoul

13、d is not lost.N/AN/AqN/AN/AN/AOQ口是否用戶需求追溯矩陣Requirements Traceability Matrix編號(hào) Reference：版本號(hào)Version：工程 Entity:頁(yè)碼 Page ： 7 of 7廠房設(shè)施/公用工程設(shè)備/系統(tǒng)名稱Facility/Utilities/Equipment System Name泡罩包裝機(jī)追溯矩陣Traceability Matrix是否執(zhí)行序號(hào)Item功能描述Function description功能風(fēng)險(xiǎn)評(píng)估(適用T”，不適用“N/A”) Function Risk Assessment (4 for applicable and N/A for not applicable)12345616應(yīng)根據(jù)風(fēng)險(xiǎn)分析安裝緊急開關(guān)，緊急開關(guān)應(yīng)便 于操作者觸及。Emergency stop buttons (mushroom type) shall be placed at position easy to touch according the risk analysisN/AN/AN/AN/AN/AN