方案01海潤(rùn)精制藥車(chē)間一pw oq

1、海潤(rùn)一車(chē)間純化水分配系統(tǒng)運(yùn)行確認(rèn)方案PW DISTRIBUTION SYSTEM OF HAIRUN WORKSHOP ONEOQ PROTOCOL方案號(hào) DOC No：OQP-PW2-1-01確認(rèn)地點(diǎn) Location： 海潤(rùn)一車(chē)間 HAIRUN Workshop One江蘇奧賽康藥業(yè)JIANGSU AOSAIKANGPHARMACEUTICAL CO.,確認(rèn)方案的Qualification Protocol Approval:方案起草Prepared By：方案審核Reviewed By：方案批準(zhǔn)Approved By：職務(wù)/Title/Name簽名 Signature日期 Date質(zhì)量/

2、部門(mén)/Dep./Name簽名 Signature日期 Date設(shè)備部/生產(chǎn)部/質(zhì)量部/部門(mén)/Dep./Name簽名 Signature日期 Date朗脈驗(yàn)證部/目錄Contente41、目的2、范圍3、職責(zé)PurScope4Responsibility44、系統(tǒng)描述5、文檔化6、數(shù)據(jù)收集System Description4ation6Dollection7SHE Notice7ation Verification87、安全注意事項(xiàng)8、文件確認(rèn)9、運(yùn)行確認(rèn)過(guò)程O(píng)Q Pros8IQ 完成情況的確認(rèn) IQ Completion Verification8人機(jī)界面檢查 HMI Verificatio

3、n9運(yùn)行功能確認(rèn) Operational Function Verification109.4和聯(lián)鎖確認(rèn) Alarms anderlocks Verification10生產(chǎn)參數(shù)確認(rèn) Production Parameters Verification11峰流量確認(rèn) Peak Flow Verification129.7過(guò)程確認(rèn) Disinfection Verification13運(yùn)行確認(rèn)過(guò)程中偏差匯總 OQ Deviation Summary13運(yùn)行確認(rèn)總結(jié) OQ Summary Report1410、參考文獻(xiàn) Referen 1411、附錄列表 Appendix Table16附錄附錄附

4、錄附錄附錄附錄附錄附錄附錄附錄附錄附錄Appendix 117Appendix 218Appendix 319Appendix 420Appendix 521Appendix 623Appendix 725Appendix 826Appendix 927Appendix 1028Appendix 1130Appendix 12311、目的 Pure本運(yùn)行確認(rèn)用以證實(shí)海潤(rùn)一車(chē)間的純化水分配系統(tǒng)的運(yùn)行符合設(shè)計(jì)標(biāo)準(zhǔn)。The OQ is to demonstratet the operation of the PW distribution system of theHAIRUN workshop o

5、ne conform to the design criteria.2、范圍 Scope本方案適用一車(chē)間的純化水分配系統(tǒng)的運(yùn)行確認(rèn)。This protocol is just applicable to the OQ of the PW distribution system of theHAIRUN workshop one.3、職責(zé) Responsibility所有開(kāi)展的工作將按照驗(yàn)證管理總則（HQAM-200）執(zhí)行。All activities will be executed according to the (HQAM-200).列在方案第二頁(yè)的負(fù)責(zé)和批準(zhǔn)本方案。Thenel lis

6、ted on the second page take the responsibility of the reviewingand approval of this protocol.凡是參與本方案確認(rèn)測(cè)試的 All participants should be listed凡是參與本方案確認(rèn)測(cè)試的錄表”（HRMR-009）中。（培訓(xùn)都應(yīng)列在附錄 1“檢查測(cè)試簽字單”上。he Appendix 1 “Testers Signature Form”.都應(yīng)經(jīng)過(guò)本方案的培訓(xùn)，列在附表“培訓(xùn)記表原件留存于培訓(xùn)中，復(fù)印件將附于本運(yùn)行確認(rèn)的中）。All participants should be tr

7、ained of this protocol and listed on the “TrainingRecord” （HRMR-009）. (All original records should be archived by the in thetraining, and the copies will be attached to the qualification report).4、系統(tǒng)描述 System Description本純化水分配系統(tǒng)由朗脈潔凈技術(shù)設(shè)計(jì)制造與安裝，主要由儲(chǔ)罐、水泵、換熱器、儀器儀表、閥門(mén)以及分配管路組成。本系統(tǒng)安裝于室內(nèi)。主要用于純化水的與分配。系統(tǒng)由一個(gè)循環(huán)

8、：This PW distribution system is designed, manufactured and installed by theSHANGHAI MACROPROS LUSTRATION TECHNOLOGY Co.,. Themain components are, pump, heat exchanger, instruments, valves and pi. Thesystem is indoor-installed, and used to storage and distribution the Purified Water.純化水在一個(gè)豎直安放的 2m3 容

9、量的不銹鋼罐內(nèi)，并通過(guò)一個(gè)水泵循環(huán)至每個(gè)使用點(diǎn)，最后回到該不銹鋼儲(chǔ)罐內(nèi)。3, and delivered to each use poThe PW is stored itical SSbya centrifugal pump, return to the SSast.分配管路系統(tǒng)由一個(gè) DN40 的管道環(huán)路組成，并通過(guò)衛(wèi)生隔膜閥分配到使用點(diǎn)。The distribution pipe line is a DN40 pidiaphragm valves.loop, and distributed by the一個(gè)雙管板列管式換熱器安裝在分配系統(tǒng)的靠近儲(chǔ)罐的回路管道上，通過(guò)水罐側(cè)、換熱器前后的溫

10、度傳感器控制系統(tǒng)溫度。A double-tube-sheet heat exchanger is installed on the return loop near the,and to control the system temperature by the temperature transmitters which locatedon theide, before and after the heat exchanger.一個(gè)液位傳感器安裝在儲(chǔ)罐內(nèi)，以儲(chǔ)罐的液位。A level meter is locatedhe, aim to supervise and control thele

11、vel.一個(gè)噴淋球安裝在儲(chǔ)罐上方，以使儲(chǔ)罐內(nèi)表面保持濕潤(rùn)。A spray ball is installed on the top of theerior wetted.ernal of the, aim to keep the一個(gè)呼吸過(guò)濾器安裝在儲(chǔ)罐罐頂，以防止當(dāng)水位下降時(shí)來(lái)自外界空氣的污染。該呼吸器裝有電加熱保溫裝置，以便始終保持呼吸器的濾芯處于干燥狀態(tài)。A vent filter is installed on the top of the, so as to prevent the outsidecontaminants in case of the level drop. Elect

12、rical heating jacket is installed on thefilter house, so as to keep the filter cartridge dry.在出水和回水管均設(shè)計(jì)了一個(gè)取樣口，以便對(duì)水進(jìn)行取樣。Two sle valves are respectively installed on the supply loop and the returnloop, so as to sle the PW.兩個(gè)壓力表分別安裝在儲(chǔ)罐上和水泵后，用于觀察罐內(nèi)與供水壓強(qiáng)。Two prere gauges are respectively installed on the

13、and after the pump, soas to watch the prere of theand the supply water.一個(gè)流量計(jì)安裝在分配系統(tǒng)的靠近儲(chǔ)罐的回路管控制回路流量。，以通過(guò)改變水泵轉(zhuǎn)速A level meter is installedhe return loop, so as to control the return watervelocity by modifying the pump roional rate.一個(gè)電導(dǎo)率儀安裝在分配系統(tǒng)的靠近儲(chǔ)罐的回路管，以監(jiān)測(cè)環(huán)水的電導(dǎo)率。A conductivity transmitter is installed

14、 conductivity of the system.he return loop, so as to supervise the在純化水循環(huán)管道回路靠近儲(chǔ)罐的位置安裝了 2 個(gè)氣動(dòng)隔膜閥，用于控制循環(huán)純化水的質(zhì)量，當(dāng)純化水的電導(dǎo)率不符合可接受標(biāo)準(zhǔn)時(shí)，回純化水儲(chǔ)罐的氣動(dòng)閥關(guān)閉，管道對(duì)外排放氣動(dòng)閥打開(kāi)，將不合格水對(duì)外排放；反之回純化水儲(chǔ)罐的氣動(dòng)閥打開(kāi)，管道對(duì)外排放氣動(dòng)閥關(guān)閉。Two patic diaphragm valves are installed on the return line which near the, so as to control the PW quality. Wh

15、en the conductivity do not conform to theacceptance criteria, the valve which return to theclosed as the discharging valveopened to discharge the unacceptable water. Otherwise the return valve closed as the discharging valve opened.當(dāng)壓縮空氣無(wú)壓力時(shí)這兩個(gè)氣動(dòng)閥應(yīng)處于正常循環(huán)狀態(tài)，即回儲(chǔ)罐的氣動(dòng)閥門(mén)應(yīng)保持打開(kāi)狀態(tài)，對(duì)外排放氣動(dòng)閥應(yīng)處于關(guān)閉狀態(tài)。When the CA

16、 prere lost, these two valves are in normal conditiont thereturn valve opened as the discharging valve closed.5、文檔化ation運(yùn)行確認(rèn)文件必須包括：OQation must include:本確認(rèn)方案 This qualification protocol;All pred texts,確認(rèn)過(guò)程中所有產(chǎn)生的打印文字、圖表和手寫(xiě)charts, handwriting records from the qualification pros;所有參加確認(rèn)檢查的簽字單 All partic

17、ipants signature;方案 Deviations and investigations;確認(rèn)過(guò)程中可能出現(xiàn)的偏差和ay occur during the qualification proplan whi最終的確認(rèn)Final qualification report.6、數(shù)據(jù)收集 Dollection所有批準(zhǔn)都要用黑色水筆填寫(xiě)。All approval should be written by black ink pen.須用黑色水筆填寫(xiě)。Report should be filled wiblack ink pen.方案或不得撕毀和任意涂改，確需更改時(shí)應(yīng)把原內(nèi)容用橫線劃去（原有信

18、息仍清晰可辨）后，在旁邊書(shū)寫(xiě)準(zhǔn)確的內(nèi)容，并簽注和日期，必要時(shí)應(yīng)當(dāng)說(shuō)明更改理由。不可刮，不可用橡皮擦，不可用重筆涂改。Protocol or report shall not be torn or erased. If nesary, any corrections shouldbe crossed out wisingle line, and initialed and dated. Where the reason for adeletion is not obvious a brief explanation should be provided. There should not bea

19、ny use of knife scratches, eraser, and heavy pencil erasures.運(yùn)行確認(rèn)結(jié)束后，收集所有的確認(rèn)結(jié)果得出確認(rèn)結(jié)論，形成確認(rèn)After finishing the OQ, all results from the qualification should come。o a, and be formedo a qualification report.7、安全注意事項(xiàng) SHE Notice若進(jìn)入夾層，必須戴安全帽，必要時(shí)應(yīng)配備安全帶與安全鞋。If it is nesary to geto the ceiling, a safety helme

20、t should be worn on, and insome cases, the harness and safety shoes are important.若使用梯子登高，必須扶穩(wěn)梯子，注意跌落。If it is nesary to ascend a height wiladder, please hold the handrail, andpay careful attention to prevent slipor falling down.8、文件確認(rèn)ation Verification檢查是否存在已經(jīng)批準(zhǔn)的文件以指導(dǎo)整個(gè)運(yùn)行確認(rèn)測(cè)試，過(guò)程中有關(guān)該系統(tǒng)的確認(rèn)必須嚴(yán)格依據(jù)上述文件。

21、Verifyt the approveds are available to direct the whole OQ pros.All relevant verification should be based on the aforementioneds.列出每一個(gè)文件并檢查其有效性，將檢查結(jié)果在附錄 2“文件確認(rèn)表”。List eachAppendix 2 “and verify its validity, and record the test resultsation Verification Form”.o the9、運(yùn)行確認(rèn)過(guò)程O(píng)Q Pros9.1 IQ 完成情況的確認(rèn) IQ Co

22、mpletion Verification9.1.1 測(cè)試目的 Pure在開(kāi)始本次確認(rèn)前應(yīng)確定本系統(tǒng)的IQ已批準(zhǔn)，IQ 中相關(guān)偏差已關(guān)閉。Before this qualificaiton, the IQ Report of this system should be approved, andthe relavent deviations during IQ should be closed.9.1.2 測(cè)試方法 Test Procedure檢查本系統(tǒng)IQ是否已被批準(zhǔn)，以及其中相關(guān)變更以及偏差的實(shí)施情況。將結(jié)果于附錄 3“IQ 完成情況確認(rèn)”。Verify whether the IQ re

23、pors been approved, and the condition of theimplemenion of the relevant changes and deviations. Record the resultsAppendix 3 “IQ Completion Verification”.o9.1.3 可接受標(biāo)準(zhǔn) Acceptance CriteriaIQ已批準(zhǔn)。IQ repors been approved.相關(guān)偏差已關(guān)閉。Relevant deviations have been closed.系統(tǒng)處于正常良好的狀態(tài)。System is in good and norma

24、l condition.9.2 人機(jī)界面檢查 HMI Verification9.2.1 測(cè)試目的 Pure確認(rèn)控制系統(tǒng)人機(jī)界面功能符合設(shè)計(jì)要求。Verify the function of human machineaccordance with Design.erface of control system is in9.2.2 測(cè)試方法 Test Procedure檢查圖形頁(yè)面是否符合工藝和設(shè)備、裝置和儀表的實(shí)際安裝情況，注意其顯示狀態(tài)（閥門(mén)、泵）、模擬量測(cè)定值、顏色、符號(hào)和號(hào)，和其它在界面上顯示的信息。確認(rèn)屏幕的導(dǎo)航（從一個(gè)圖形進(jìn)入到另外一個(gè)）。確認(rèn)各個(gè)用戶等級(jí)符合相應(yīng)的操作權(quán)限。將結(jié)

25、果于附錄 4“人機(jī)界面檢查”。Verify the graphical pages in comparison with the pros and the actualinstallationerms of equipment, deviand instruments, pay attention to the susrepresenion (valves, pumps),ogue measurement, colors, symbols and tagnumber, and any other data shown by theerface. Verify screen navigation

26、 (goingfrom on graphic to another one). Verify the different user level correspond to relevantadministration function. Record the resultso Appendix 4 “HMI Verification”.9.2.3 可接受標(biāo)準(zhǔn) Acceptance Criteria圖形頁(yè)面代表了實(shí)際的安裝狀態(tài)。Graphical pages represent the actual installation of the system.數(shù)字狀態(tài)、模擬數(shù)據(jù)、符號(hào)、顏色、號(hào)、儀表和

27、設(shè)備是正確顯示。Any digital sus,ogue data, symbol, color, tag number, instruments anddevice is correctly shown and indicated.屏幕導(dǎo)航正常工作。Screen navigation (from a page to the nest and the previous one) works correctly.操作權(quán)限符合工藝要求。Administrate user function conforms to the pros requirement.9.3 運(yùn)行功能確認(rèn) Operational

28、 Function Verification9.3.1 測(cè)試目的 Pure確認(rèn)系統(tǒng)及其主要組件能夠按照其功能說(shuō)明正常運(yùn)行。Verifyt system and the main components of the system can progressexecution according to the function specifications.9.3.2 測(cè)試方法 Test Procedure檢查系統(tǒng)中的控制閥門(mén)、泵、熱交換器、變送器和就地儀表的運(yùn)行情況。按照操作手冊(cè)運(yùn)行系統(tǒng)。檢查實(shí)際的運(yùn)行情況并與預(yù)先確定的功能說(shuō)明進(jìn)行比較。將結(jié)果于附錄 5“運(yùn)行功能確認(rèn)”。Verify the wo

29、rks sus of the control valves, pumps, heat exchanger, transmittersand field instrumentshe system. Run the system according to the operationalmanual. Check the actual working se and compare with the pre-defined functionspecification. Record the resultsVerification”.o Appendix 5 “Operational Function9

30、.3.3 可接受標(biāo)準(zhǔn) Acceptance Criteria系統(tǒng)中的主要組件能夠按照其功能說(shuō)明進(jìn)行正常的工作。The main componentsspecification.he system can normally work according to the function系統(tǒng)能夠按照預(yù)先確定的功能說(shuō)明進(jìn)行運(yùn)行。The system can progress execution according to the pre-defined function specifications.9.4和聯(lián)鎖確認(rèn) Alarms anderlocks Verification9.4.1 測(cè)試目的 Pu

31、re確認(rèn)當(dāng)和聯(lián)鎖情況發(fā)生時(shí)，控制系統(tǒng)有檢測(cè)、傳達(dá)和反應(yīng)的能力。Verify the capability of the control system to detect, communicate and react whenalarms anderlocks condition occurred.9.4.2 測(cè)試方法 Test Procedure對(duì)每個(gè)或聯(lián)鎖，使用下面所列的方法之一來(lái)產(chǎn)生或聯(lián)鎖情況：1.2.3.4.5.修改的閾值使用適當(dāng)?shù)男盘?hào)發(fā)生器斷開(kāi)裝置（傳感器、光電計(jì)、儀表）斷開(kāi)或短接信號(hào)線（僅對(duì)數(shù)字信號(hào)）模擬“實(shí)際條件”（例如將元件放入水浴中模擬高溫）將結(jié)果于附錄 6“和聯(lián)鎖確認(rèn)”。Fo

32、r each alarm/following:erlock, generatearm/erlock condition using one of thea)b)c)d)e) elementModifying the alarm threshold Using a proper signal generatorDisconnecting the device (sensor, photocell, instrument) Disconnecting or shorting the signal cable (digital signals only)Simulating “real condit

33、ion” (e.g.: high temperature simulated putting thehe bath).Record the resultso Appendix 6 “Alarms anderlocks Verification”.9.4.3 可接受標(biāo)準(zhǔn) Acceptance Criteria所有的認(rèn)。All alarms/聯(lián)鎖能夠正確地產(chǎn)生。觸發(fā)產(chǎn)生的預(yù)期的結(jié)果和動(dòng)作等到確erlocks are correctly generated and any expected resulted resultsand actions due to alarms triggering ar

34、e verified.9.5 生產(chǎn)參數(shù)確認(rèn) Production Parameters Verification9.5.1 測(cè)試目的 Pure確認(rèn)在不使用純化水的情況下生產(chǎn)的參數(shù)。Verify the production parameters without opened po9.5.2 測(cè)試方法 Test Procedureof use (recirculation).正常運(yùn)行系統(tǒng)。關(guān)閉所有的使用點(diǎn)，下生產(chǎn)參數(shù)，即液位、壓力、流速、電導(dǎo)率等。將結(jié)果于附錄 7“生產(chǎn)參數(shù)確認(rèn)”。Run the PW distribution system. With all pos of use closed

35、, record theProduction parameters, i.e. level, prere, flow rate, conductivity, etc. Record theresultso Appendix 7 “Production Parameters Verification”.9.5.3 可接受標(biāo)準(zhǔn) Acceptance Criteria生產(chǎn)參數(shù)符合工藝要求。The production parameters are in compliance with the pros requirement.9.6 峰流量確認(rèn) Peak Flow Verification9.6.1

36、 測(cè)試目的 Pure確認(rèn)在峰流量（最大使用量）情況下，該純化水和分配系統(tǒng)的能力。Verify the capacity of the storage and distribution systems during peak flow condition.9.6.2 測(cè)試方法 Test Procedure將純化水注入儲(chǔ)罐至滿。打開(kāi)需要同時(shí)使用的各個(gè)點(diǎn)，以模擬最大的水消耗情況，流量。生產(chǎn)參數(shù)（儲(chǔ)罐液位、水電導(dǎo)率、壓力、流速等）。并進(jìn)行核黃素試驗(yàn)：于試驗(yàn)前使用 365nm 紫外燈檢查水罐內(nèi)壁無(wú)熒光劑影響試驗(yàn)結(jié)果；配制 0.08g/L 至 0.22g/L 的核黃素水溶液，均勻的噴撒在儲(chǔ)罐內(nèi)表面；待峰流

37、量結(jié)束后，用 365nm 紫外燈檢查內(nèi)表面是否完錄 8“峰流量確認(rèn)”。將結(jié)果于附Feed the Purified Watero the storageuntil full. Open contemporaneouslyum water consumption foreseen by theall needed pos of use to simulate thedesigned peak flow rate. Record the production parameters (storage level, waterconductivity, prere, flow rate etc.).

38、And execute the riboflavin fluorescence test:Before the test, use the 365nm wavelength UV lto inspecterior surface for thefluorescence may impact the test result. Spray the 0.080.22g/L riboflavin aqueoussolution on the365nm UV lerior surface of the. After the peak flow, inspect the result withto ver

39、ifyt the spray cover effect. Record the resultsoAppendix 8 “Peak Flow Verification”.9.6.3 可接受標(biāo)準(zhǔn) Acceptance Criteria滿足最大使用量。The peak flow is satisfied.生產(chǎn)參數(shù)符合工藝要求。The production parameters are in compliance with pro噴淋球覆蓋試驗(yàn)結(jié)果可接受。Spray ball coverage testing result accepted.s requirement.9.7過(guò)程確認(rèn) Disinfec

40、tion Verification9.7.1 測(cè)試目的 Pure確認(rèn)系統(tǒng)能夠在整個(gè)周期內(nèi)，以所要達(dá)到的溫度進(jìn)行水循環(huán)。Verifyt the system is able to circulate purified water at the temperature whichaccording to the disinfection requirement, withhe entire distribution loop and for the entire cycle.9.7.2 測(cè)試方法 Test Procedure確保沒(méi)有使用點(diǎn)在使用。使用環(huán)路回等待溫度到達(dá)設(shè)定點(diǎn)(80)。在整個(gè)的熱交換

41、器，加熱環(huán)路中的純化水。周期內(nèi)（1 小時(shí)），每 10 分鐘下系統(tǒng)中所有溫度探頭的溫度，特別需注意的是關(guān)鍵點(diǎn)（環(huán)路回?zé)峤粨Q器前的冷點(diǎn)）。將結(jié)果于附錄 9“過(guò)程確認(rèn)”。Be suret no poof use is open. Use the heat exchanger on the return loop toheat the purified water. Wait the reaching of the set potemperature (80). Recordthe temperature every 10 minutes for 1 hour whieasured by any pr

42、obe of thel concern of cold spot before thesystem, paying attention to the critical po(speheat exchanger on the return loop of the loop). Record the results“Disinfection Verification”.9.7.3 可接受標(biāo)準(zhǔn) Acceptance Criteriao Appendix 9在整個(gè)周期（達(dá)到設(shè)定值后）內(nèi)所有的監(jiān)測(cè)點(diǎn)的溫度大于 80。All temperature measurements during the Disi

43、nfection cycle are highern theset po(80 ) during the entire cycle (after reaching the set po).9.8 運(yùn)行確認(rèn)過(guò)程中偏差匯總OQ Deviation Summary確認(rèn)過(guò)程中如（HQAM-007）或變更，應(yīng)按照偏差處理標(biāo)準(zhǔn)管理規(guī)程產(chǎn)生的任何偏差，于附錄 10“運(yùn)行確認(rèn)偏差”中，任何超出規(guī)定的結(jié)果都要。If any deviations and changes arise during the qualification proDeviation Handling Procedure (HQAM-007

44、) should be followeds, Standardto report the Report”. Anydeviations, record the proso the Appendix 10 “OQ Deviationresults out of specifications should be investigated.9.9 運(yùn)行確認(rèn)總結(jié) OQ Summary Report總結(jié)運(yùn)行確認(rèn)的結(jié)果，將結(jié)論列在附錄 11“運(yùn)行確認(rèn)總結(jié)”中。運(yùn)行確認(rèn)合格后，方可進(jìn)行后續(xù)驗(yàn)證活動(dòng)。Summarize the OQ results, and thes should be listedhe A

45、ppendix11 “OQ summary”. After the approval of IQ, the next activities will be authorized tobe executed.10、參考文獻(xiàn) Referen驗(yàn)證管理總則（HQAM-200） (HQAM-200)偏差處理標(biāo)準(zhǔn)管理程序（HQAM-007） (HQAM-007)藥品生產(chǎn)質(zhì)量管理規(guī)范（2010 版）(CFDA) Good Manufacturing Practice, revised in 2010歐盟 GMP 的附錄 15-驗(yàn)證和確認(rèn)Annex 15 to the EU Guide to Good Man

46、ufacturing Practice “Validation and Qualification”(ISPE)新建和改造的工廠年 1 月工程指南，第 4 卷-水和蒸汽系統(tǒng)，第 2 版 2011(ISPE)Pharmaceutical Engineering Guides for New and Renovated facilities,Volume 4: Water andsystems,ernational Society for PharmaceuticalEngineering, Second edition, January 2011.中國(guó)藥典 2010 版China pharmac

47、opoeia 2010 Edition歐洲藥典第 8 版European Pharmacopoeia the 8th edition藥典第 37 版US Pharmacopoeia the 37th edition11、附錄列表 Appendix Table附錄號(hào)Appendix No.文件Title頁(yè)數(shù) Number of Pages1.檢查測(cè)試簽字單 Testers Signature Form12.文件確認(rèn)表ation Verification Form13.IQ 完成情況確認(rèn) IQ Completion Verification14.人機(jī)界面檢查 HMI Verification15.

48、運(yùn)行功能確認(rèn) Operational Function Verification26.和聯(lián)鎖確認(rèn) Alarms anderlocks Verification27.生產(chǎn)參數(shù)確認(rèn) Production Parameters Verification18.峰流量確認(rèn) Peak Flow Verification19.過(guò)程確認(rèn) Disinfection Verification110.運(yùn)行確認(rèn)偏差OQ Deviation Report211.運(yùn)行確認(rèn)總結(jié) OQ Summary112.附件Attaent List1附錄 Appendix 1檢查測(cè)試簽字單 Testers Signature FormN

49、ameDepartment/ Company部門(mén)/公司Responsibility職責(zé)Trained or not是否已接受培訓(xùn) (Yes 是/No 否)Signature簽名Date日期是 否是 否是 否是 否是 否是 否是 否是 否是 否是 否是 否是 否Note 備注:Executed by 執(zhí)行人Date 日期 (yyyy.mm.dd)Reviewed by 審核人Date 日期 (yyyy.mm.dd)附錄 Appendix 2文件確認(rèn)表ation Verification FormNo.序號(hào)Name文件名稱Doc No.文件Ver/Date版本/日期Available?是否可用？(

50、Yes 是/No 否)1Design Specification設(shè)計(jì)說(shuō)明是 否2iagram管道儀表圖是 否3Operational Manual操作手冊(cè)是 否4是 否5是 否6是 否Note 備注：Executed by 執(zhí)行人Date 日期(yyyy.mm.dd)Reviewed by 審核人Date 日期(yyyy.mm.dd)附錄 Appendix 3IQ 完成情況確認(rèn) IQ Completion VerificationNo.序號(hào)Item項(xiàng)目Condition條件Conform?是否符合？(Yes 是/No 否)1IQ report IQApproved已批準(zhǔn)是 否2Deviatio

51、ns偏差Closed已關(guān)閉是 否3System系統(tǒng)Normal and Good正常良好是 否Note 備注：Executed by 執(zhí)行人Date 日期(yyyy.mm.dd)Reviewed by 審核人Date 日期(yyyy.mm.dd)附錄 Appendix 4人機(jī)界面檢查 HMI VerificationCheck Description檢查描述Acceptance Criteria可接受的標(biāo)準(zhǔn)Pass/ Fail通過(guò)/失敗Check the graphical pages of the system step by step.逐一檢查系統(tǒng)圖形界面。Graphical pages

52、represent the actual installation of the system. 圖形頁(yè)面代表了系統(tǒng)的實(shí)際安裝狀態(tài)。Visual check whether any digitalsus,ogue data, symbol, color, tag number, instruments and device is correctly shown.目檢所有數(shù)字量的狀態(tài)、模擬量數(shù)據(jù)、符號(hào)、顏色、號(hào)、儀表和裝置是否正確顯示。Any digital sus,ogue data, symbol, color, tag number, instruments and device is c

53、orrectly shown.所有數(shù)字量的狀態(tài)、模擬量數(shù)據(jù)、符號(hào)、顏色、號(hào)、儀表和裝置已正確顯示Execute and check the screen navigation function according to operational manual. (going from on graphic to another one)按照操作手冊(cè)執(zhí)行并檢查屏幕導(dǎo)航功能。（從一個(gè)圖形進(jìn)入到另外一個(gè)）Screen navigation works correctly.屏幕導(dǎo)航工作正常。For each foreseen user level, enter respectively the righ

54、t password and wrong password and verify if acs is allowed.對(duì)應(yīng)每種操作等級(jí)，分別輸入正確與錯(cuò)誤的，檢查其登錄情況及操作權(quán)限。Operator操作員Supervisor工藝員Administrator管理員Note 備注：Executed by 執(zhí)行人Date 日期 (yyyy.mm.dd)Reviewed by 審核人Date 日期 (yyyy.mm.dd)附錄 Appendix 5運(yùn)行功能確認(rèn) Operational Function VerificationOperational Function運(yùn)行功能Check Descrip

55、tion檢查描述Pass/ Fail通過(guò)/失敗Start啟動(dòng)Normal run正常運(yùn)行Stop停機(jī)Component組件Check Description檢查描述Pass/ Fail通過(guò)/失敗Pump水泵Check the pump ishe right direction and not dead headed during operation.檢查水泵運(yùn)行時(shí)轉(zhuǎn)向正確且沒(méi)有空轉(zhuǎn)。Pump is running well and no noise.運(yùn)行正常，無(wú)異聲。Patically Valve氣動(dòng)閥門(mén)Check patically valve can open and close corr

56、ectly when button is pressed or released.檢查當(dāng)氣動(dòng)按鈕被壓下或時(shí)，氣動(dòng)閥門(mén)能夠正確地打開(kāi)或關(guān)閉。Manual Valve手動(dòng)閥門(mén)Check manual valves can be opened /closed easily by hand.檢查手動(dòng)閥門(mén)能被容易的打開(kāi)或關(guān)閉。Regulating Valve調(diào)節(jié)閥Check regulating valve can be regulated according to pros requirement.檢查調(diào)節(jié)閥能按照工藝要求進(jìn)行調(diào)節(jié)。Field instruments就地儀表Check field in

57、struments (level transmitter, flow device,prere gauge and conductivity transmitter) can correctly work.檢查就地儀表（液位變送器、流量計(jì)、壓力表和電導(dǎo)率變送器）能正確地運(yùn)行。Operational Function運(yùn)行功能Check Description檢查描述Pass/ Fail通過(guò)/失敗DisinfectionAcceptance Criteria 可接受的標(biāo)準(zhǔn)Yes 是/No 否The main componentshe system can normally work accordi

58、ng to the function specification.系統(tǒng)中的主要組件能夠按照其功能說(shuō)明進(jìn)行正常的工作。是 否The system can progress execution according to the pre-defined function specifications.系統(tǒng)能夠按照預(yù)先確定的功能說(shuō)明進(jìn)行運(yùn)行。是 否Note 備注：Executed by 執(zhí)行人Date 日期 (yyyy.mm.dd)Reviewed by 審核人Date 日期 (yyyy.mm.dd)附錄 Appendix 6和聯(lián)鎖確認(rèn) Alarms anderlocks VerificationAl

59、arms/erlocks和聯(lián)鎖Check method檢查方法Expected Results預(yù)期的結(jié)果Pass or not是否通過(guò)Level Low Low超低液位Modifying the Threshold調(diào)整閾值Pop up Alarm Window,System Stops彈出窗口，系統(tǒng)停機(jī)是 否Level Low低液位Modifying the Threshold調(diào)整閾值Pop up Alarm Window彈出窗口是 否Level Medium中液位Modifying the Threshold調(diào)整閾值Inlet valve of the PW generation Open純

60、化水機(jī)進(jìn)水閥門(mén)開(kāi)啟是 否Level High高液位Modifying the Threshold調(diào)整閾值Inlet valve of the PW generation Closed純化水機(jī)進(jìn)水閥門(mén)關(guān)閉是 否Level High High液位Modifying the Threshold調(diào)整閾值Pop up Alarm Window彈出窗口是 否Disinfection Temperature Low溫度低Modifying the Threshold調(diào)整閾值Inlet valve of the UtilityTurned Up工業(yè)蒸汽進(jìn)汽閥門(mén)開(kāi)大是 否Conductivity High電導(dǎo)率