XXXX年度產(chǎn)品質(zhì)量回顧分析報(bào)告

1、2012年度產(chǎn)品質(zhì)量回顧分析報(bào)告（） 01-2010編號(hào): 第32頁(yè)，共53頁(yè)編號(hào): 第45頁(yè)，共53頁(yè)2012年度產(chǎn)品質(zhì)量回顧分析報(bào)告回顧期限：2011年12月2012年11月編號(hào)：ZLHG-BX-2012起草QA簽名： 時(shí)間：審核生產(chǎn)部經(jīng)理簽名： 時(shí)間：研發(fā)部經(jīng)理簽名： 時(shí)間：物控部經(jīng)理簽名： 時(shí)間：設(shè)備部經(jīng)理簽名： 時(shí)間：質(zhì)量部經(jīng)理簽名： 時(shí)間：生產(chǎn)負(fù)責(zé)人簽名： 時(shí)間：批準(zhǔn)質(zhì)量負(fù)責(zé)人簽名： 時(shí)間：目 錄一、基本情況概述二、生產(chǎn)和質(zhì)量控制情況分析評(píng)價(jià)1、產(chǎn)品質(zhì)量標(biāo)準(zhǔn)2、產(chǎn)品質(zhì)量回顧3、生產(chǎn)分析4、質(zhì)量事故回顧5、偏差回顧6、超常超標(biāo)回顧7、穩(wěn)定性試驗(yàn)8、公用系統(tǒng)、設(shè)施設(shè)備情況9、變更控制回

2、顧10、委托生產(chǎn)情況回顧11、委托檢驗(yàn)情況回顧12、不良反應(yīng)13、產(chǎn)品退貨14、投訴15、產(chǎn)品召回16、藥品注冊(cè)相關(guān)變更的申報(bào)、批準(zhǔn)及退審三、結(jié)論一、基本情況概述1概要：根據(jù)2010版GMP要求，結(jié)合產(chǎn)品年度質(zhì)量回顧分析標(biāo)準(zhǔn)操作規(guī)程（SOP-ZL-QA-014）的規(guī)定，對(duì)進(jìn)行產(chǎn)品質(zhì)量回顧分析。本報(bào)告抽取在回顧期限內(nèi)所有放行批次的基礎(chǔ)上重點(diǎn)對(duì)該品種進(jìn)行了統(tǒng)計(jì)和趨勢(shì)分析。2回顧期限：2011年12月1日2012年11月30日。3生產(chǎn)情況：本回顧年度共放行藥材細(xì)粉118批，成品105批，總產(chǎn)量為503585（盒），平均收率為95.92%(按放行產(chǎn)量統(tǒng)計(jì))。生產(chǎn)中嚴(yán)格按照工藝規(guī)程及標(biāo)準(zhǔn)操作規(guī)程的要求組

3、織生產(chǎn),經(jīng)粉碎、總混、泛丸、干燥、包衣、干燥、選丸、打光、內(nèi)包、外包等工序，完成生產(chǎn)。4規(guī)格及包裝4.1規(guī)格：-4.2包裝：-5有效期及貯藏5.1有效期：24個(gè)月。5.2貯藏：密閉，防潮。6產(chǎn)品特點(diǎn)6.1性狀：-6.2功能主治：-6.3用法用量：-7處方與批量8處方依據(jù)8.1批準(zhǔn)文號(hào)8.2質(zhì)量標(biāo)準(zhǔn)依據(jù)：8.3制劑每次投料量：9生產(chǎn)工藝流程粉碎配料總混泛丸干燥包衣干燥選丸打光內(nèi)包裝外包裝入庫(kù)檢驗(yàn) 潔凈區(qū)二、生產(chǎn)和質(zhì)量控制情況分析1產(chǎn)品質(zhì)量標(biāo)準(zhǔn)1.1藥材細(xì)粉質(zhì)量標(biāo)準(zhǔn)項(xiàng)目名稱內(nèi)控標(biāo)準(zhǔn)法定標(biāo)準(zhǔn)性 狀細(xì) 度微生物限度細(xì)菌數(shù)霉菌和酵母菌數(shù)大腸菌群大腸埃希菌活螨1.2成品質(zhì)量標(biāo)準(zhǔn)項(xiàng)目名稱內(nèi)控標(biāo)準(zhǔn)法定標(biāo)準(zhǔn)性狀

4、鑒別檢查水分裝量差異溶散時(shí)限細(xì)菌數(shù)霉菌和酵母菌數(shù)大腸菌群大腸埃希菌活螨2產(chǎn)品質(zhì)量回顧2.1原輔料購(gòu)進(jìn)情況回顧原輔料供應(yīng)商入庫(kù)批次評(píng)價(jià)：本回顧年度內(nèi)，供應(yīng)商質(zhì)量管理均按相關(guān)文件嚴(yán)格執(zhí)行，供應(yīng)商質(zhì)量管理的風(fēng)險(xiǎn)處于可控狀態(tài)。2.2原輔料質(zhì)量問(wèn)題回顧物料名稱供應(yīng)商不合格批次不合格項(xiàng)目原因處理意見/評(píng)價(jià)：本回顧年度內(nèi)購(gòu)進(jìn)的原輔料均符合質(zhì)量標(biāo)準(zhǔn)。2.3包裝材料質(zhì)量問(wèn)題回顧物料名稱供應(yīng)商不合格批次不合格項(xiàng)目原因處理意見/評(píng)價(jià)：本回顧年度內(nèi)購(gòu)進(jìn)的包裝材料均符合質(zhì)量標(biāo)準(zhǔn)。2.4中間產(chǎn)品質(zhì)量回顧本回顧年度內(nèi)生產(chǎn)的藥材細(xì)粉所有批次的性狀、細(xì)度、微生物限度的檢驗(yàn)結(jié)果均符合內(nèi)控標(biāo)準(zhǔn)（檢驗(yàn)結(jié)果詳見QC檢驗(yàn)報(bào)告書），合格率

5、達(dá)到100%，可以認(rèn)為在此工藝條件下生產(chǎn)的產(chǎn)品均能達(dá)到產(chǎn)品的質(zhì)量標(biāo)準(zhǔn)。2.5成品質(zhì)量回顧我們對(duì)本回顧年度內(nèi)生產(chǎn)的成品所有批次進(jìn)行統(tǒng)計(jì)和趨勢(shì)分析。2.5.1成品性狀、鑒別、水分、裝量差異、溶散時(shí)限、微生物限度、含量檢驗(yàn)結(jié)果的統(tǒng)計(jì)數(shù)據(jù)（檢測(cè)結(jié)果來(lái)源于該批QC檢驗(yàn)報(bào)告書）。111201符合規(guī)定符合規(guī)定3.8符合規(guī)定26符合規(guī)定8.03.9111202符合規(guī)定符合規(guī)定2.9符合規(guī)定33符合規(guī)定6.34.0111203符合規(guī)定符合規(guī)定4.6符合規(guī)定25符合規(guī)定7.34.4111204符合規(guī)定符合規(guī)定3.7符合規(guī)定26符合規(guī)定7.64.7111205符合規(guī)定符合規(guī)定3.6符合規(guī)定25符合規(guī)定6.63.81

6、11206符合規(guī)定符合規(guī)定3.5符合規(guī)定26符合規(guī)定7.14.2120101符合規(guī)定符合規(guī)定3.9符合規(guī)定26符合規(guī)定8.04.0120102符合規(guī)定符合規(guī)定3.9符合規(guī)定25符合規(guī)定7.03.9120201符合規(guī)定符合規(guī)定3.5符合規(guī)定32符合規(guī)定6.33.9120202符合規(guī)定符合規(guī)定4.5符合規(guī)定26符合規(guī)定9.44.6120203符合規(guī)定符合規(guī)定5.0符合規(guī)定34符合規(guī)定7.44.3120204符合規(guī)定符合規(guī)定4.3符合規(guī)定35符合規(guī)定7.14.4120205符合規(guī)定符合規(guī)定3.2符合規(guī)定32符合規(guī)定8.05.2120206符合規(guī)定符合規(guī)定3.6符合規(guī)定33符合規(guī)定8.14.21202

7、07符合規(guī)定符合規(guī)定4.1符合規(guī)定26符合規(guī)定7.33.8120301符合規(guī)定符合規(guī)定4.1符合規(guī)定26符合規(guī)定6.64.5120302符合規(guī)定符合規(guī)定4.0符合規(guī)定33符合規(guī)定7.13.9120303符合規(guī)定符合規(guī)定4.7符合規(guī)定35符合規(guī)定5.54.2120304符合規(guī)定符合規(guī)定4.4符合規(guī)定25符合規(guī)定6.44.6120305符合規(guī)定符合規(guī)定3.4符合規(guī)定35符合規(guī)定7.33.8120306符合規(guī)定符合規(guī)定3.1符合規(guī)定25符合規(guī)定5.84.7120307符合規(guī)定符合規(guī)定4.1符合規(guī)定26符合規(guī)定7.14.9120308符合規(guī)定符合規(guī)定4.1符合規(guī)定26符合規(guī)定5.94.2120309符

8、合規(guī)定符合規(guī)定3.2符合規(guī)定26符合規(guī)定6.14.8120310符合規(guī)定符合規(guī)定3.3符合規(guī)定26符合規(guī)定4.44.3120311符合規(guī)定符合規(guī)定3.8符合規(guī)定30符合規(guī)定4.74.4120312符合規(guī)定符合規(guī)定4.5符合規(guī)定26符合規(guī)定4.84.5120601符合規(guī)定符合規(guī)定4.2符合規(guī)定25符合規(guī)定6.64.4120602符合規(guī)定符合規(guī)定3.4符合規(guī)定26符合規(guī)定7.04.6120603符合規(guī)定符合規(guī)定5.1符合規(guī)定30符合規(guī)定7.55.2120604符合規(guī)定符合規(guī)定4.3符合規(guī)定30符合規(guī)定6.54.4120605符合規(guī)定符合規(guī)定4.2符合規(guī)定30符合規(guī)定6.94.6120606符合規(guī)定

9、符合規(guī)定4.1符合規(guī)定30符合規(guī)定8.24.6120607符合規(guī)定符合規(guī)定4.9符合規(guī)定26符合規(guī)定7.04.6120608符合規(guī)定符合規(guī)定4.1符合規(guī)定26符合規(guī)定6.64.5120701符合規(guī)定符合規(guī)定3.6符合規(guī)定25符合規(guī)定7.23.8120702符合規(guī)定符合規(guī)定3.6符合規(guī)定26符合規(guī)定7.14.2120703符合規(guī)定符合規(guī)定3.8符合規(guī)定30符合規(guī)定7.34.2120704符合規(guī)定符合規(guī)定3.4符合規(guī)定30符合規(guī)定7.24.0120705符合規(guī)定符合規(guī)定4.3符合規(guī)定25符合規(guī)定8.94.8120706符合規(guī)定符合規(guī)定3.5符合規(guī)定30符合規(guī)定9.74.7120707符合規(guī)定符合規(guī)

10、定3.8符合規(guī)定30符合規(guī)定7.95.1120708符合規(guī)定符合規(guī)定4.1符合規(guī)定30符合規(guī)定8.45.1120709符合規(guī)定符合規(guī)定3.9符合規(guī)定30符合規(guī)定7.25.2120710符合規(guī)定符合規(guī)定3.6符合規(guī)定25符合規(guī)定8.95.2120711符合規(guī)定符合規(guī)定4.3符合規(guī)定25符合規(guī)定7.35.7120712符合規(guī)定符合規(guī)定4.8符合規(guī)定26符合規(guī)定6.95.3120801符合規(guī)定符合規(guī)定3.9符合規(guī)定29符合規(guī)定7.45.4120802符合規(guī)定符合規(guī)定4.0符合規(guī)定29符合規(guī)定7.25.4120803符合規(guī)定符合規(guī)定4.8符合規(guī)定30符合規(guī)定9.55.7120804符合規(guī)定符合規(guī)定4.

11、0符合規(guī)定30符合規(guī)定8.85.7120805符合規(guī)定符合規(guī)定4.5符合規(guī)定20符合規(guī)定7.95.0120806符合規(guī)定符合規(guī)定4.8符合規(guī)定26符合規(guī)定8.14.7120807符合規(guī)定符合規(guī)定4.5符合規(guī)定28符合規(guī)定7.85.0120808符合規(guī)定符合規(guī)定4.6符合規(guī)定20符合規(guī)定7.24.9120809符合規(guī)定符合規(guī)定4.2符合規(guī)定25符合規(guī)定8.55.6120810符合規(guī)定符合規(guī)定3.2符合規(guī)定25符合規(guī)定9.14.6120811符合規(guī)定符合規(guī)定3.4符合規(guī)定29符合規(guī)定8.94.4120812符合規(guī)定符合規(guī)定4.0符合規(guī)定25符合規(guī)定8.24.4120813符合規(guī)定符合規(guī)定4.1符合

12、規(guī)定25符合規(guī)定7.74.6120814符合規(guī)定符合規(guī)定4.4符合規(guī)定26符合規(guī)定6.54.6120815符合規(guī)定符合規(guī)定4.4符合規(guī)定25符合規(guī)定7.04.6120816符合規(guī)定符合規(guī)定3.7符合規(guī)定23符合規(guī)定6.74.1120817符合規(guī)定符合規(guī)定4.4符合規(guī)定26符合規(guī)定7.74.9120818符合規(guī)定符合規(guī)定4.7符合規(guī)定26符合規(guī)定8.35.4120819符合規(guī)定符合規(guī)定3.5符合規(guī)定26符合規(guī)定9.25.6120820符合規(guī)定符合規(guī)定4.2符合規(guī)定25符合規(guī)定8.55.1120821符合規(guī)定符合規(guī)定4.4符合規(guī)定26符合規(guī)定8.95.2120822符合規(guī)定符合規(guī)定4.0符合規(guī)定2

13、7符合規(guī)定9.55.7120901符合規(guī)定符合規(guī)定4.8符合規(guī)定25符合規(guī)定8.05.6120902符合規(guī)定符合規(guī)定3.7符合規(guī)定24符合規(guī)定9.05.0120903符合規(guī)定符合規(guī)定5.1符合規(guī)定26符合規(guī)定9.05.5120904符合規(guī)定符合規(guī)定4.1符合規(guī)定36符合規(guī)定9.45.4120905符合規(guī)定符合規(guī)定4.1符合規(guī)定38符合規(guī)定9.84.7120906符合規(guī)定符合規(guī)定3.9符合規(guī)定40符合規(guī)定8.94.9120907符合規(guī)定符合規(guī)定4.8符合規(guī)定25符合規(guī)定9.64.6120908符合規(guī)定符合規(guī)定4.4符合規(guī)定30符合規(guī)定8.64.6120909符合規(guī)定符合規(guī)定3.7符合規(guī)定20符合

14、規(guī)定9.45.0120910符合規(guī)定符合規(guī)定4.6符合規(guī)定28符合規(guī)定8.24.6120911符合規(guī)定符合規(guī)定3.6符合規(guī)定26符合規(guī)定10.14.8120912符合規(guī)定符合規(guī)定3.3符合規(guī)定28符合規(guī)定9.84.9121001符合規(guī)定符合規(guī)定3.2符合規(guī)定20符合規(guī)定9.94.9121002符合規(guī)定符合規(guī)定3.8符合規(guī)定25符合規(guī)定10.95.0121003符合規(guī)定符合規(guī)定4.1符合規(guī)定23符合規(guī)定8.65.0121004符合規(guī)定符合規(guī)定3.3符合規(guī)定30符合規(guī)定10.34.8121005符合規(guī)定符合規(guī)定3.6符合規(guī)定30符合規(guī)定11.45.2121006符合規(guī)定符合規(guī)定4.2符合規(guī)定25符

15、合規(guī)定9.94.7121007符合規(guī)定符合規(guī)定4.2符合規(guī)定25符合規(guī)定8.64.6121008符合規(guī)定符合規(guī)定4.3符合規(guī)定25符合規(guī)定9.44.6121009符合規(guī)定符合規(guī)定4.0符合規(guī)定25符合規(guī)定8.24.8121010符合規(guī)定符合規(guī)定3.8符合規(guī)定28符合規(guī)定8.24.6121011符合規(guī)定符合規(guī)定3.4符合規(guī)定26符合規(guī)定8.74.6121012符合規(guī)定符合規(guī)定3.4符合規(guī)定25符合規(guī)定8.64.6121101符合規(guī)定符合規(guī)定4.6符合規(guī)定20符合規(guī)定8.74.4121102符合規(guī)定符合規(guī)定3.7符合規(guī)定28符合規(guī)定7.74.2121103符合規(guī)定符合規(guī)定3.8符合規(guī)定25符合規(guī)定

16、9.14.2121104符合規(guī)定符合規(guī)定3.8符合規(guī)定28符合規(guī)定8.24.6121105符合規(guī)定符合規(guī)定3.6符合規(guī)定25符合規(guī)定8.84.0121106符合規(guī)定符合規(guī)定3.8符合規(guī)定25符合規(guī)定8.64.5121107符合規(guī)定符合規(guī)定3.2符合規(guī)定26符合規(guī)定8.54.5121108符合規(guī)定符合規(guī)定3.3符合規(guī)定30符合規(guī)定9.34.4121109符合規(guī)定符合規(guī)定3.8符合規(guī)定25符合規(guī)定8.44.7121110符合規(guī)定符合規(guī)定3.8符合規(guī)定20符合規(guī)定7.85.0121111符合規(guī)定符合規(guī)定3.8符合規(guī)定26符合規(guī)定7.84.8121112符合規(guī)定符合規(guī)定4.0符合規(guī)定25符合規(guī)定8.6

17、4.62.5.2用成品水分檢驗(yàn)結(jié)果繪制控制圖。序號(hào)數(shù)據(jù)序號(hào)數(shù)據(jù)序號(hào)數(shù)據(jù)序號(hào)數(shù)據(jù)序號(hào)數(shù)據(jù)X13.8X234.1X453.6X674.2X894.3X22.9X243.2X464.3X684.4X904.0X34.6X253.3X474.8X694.0X913.8X43.7X263.8X483.9X704.8X923.4X53.6X274.5X494.0X713.7X933.4X63.5X284.2X504.8X725.1X944.6X73.9X293.4X514.0X734.1X953.7X83.9X305.1X524.5X744.1X963.8X93.5X314.3X534.8X753.9X9

18、73.8X104.5X324.2X544.5X764.8X983.6X115.0X334.1X554.6X774.4X993.8X124.3X344.9X564.2X783.7X1003.2X133.2X354.1X573.2X794.6X1013.3X143.6X363.6X583.4X803.6X1023.8X154.1X373.6X594.0X813.3X1033.8X164.1X383.8X604.1X823.2X1043.8X174.0X393.4X614.4X833.8X1054.0X184.7X404.3X624.4X844.1/X194.4X413.5X633.7X853.3/

19、X203.4X423.8X644.4X863.6/X213.1X434.1X654.7X874.2/X224.1X443.9X663.5X884.2/計(jì)算平均值為=3.98；計(jì)算移動(dòng)差距R值如下表：新的子群連續(xù)的對(duì)子移動(dòng)差距R新的子群連續(xù)的對(duì)子移動(dòng)差距R13.82.90.9544.54.60.122.94.61.7554.64.20.434.63.70.9564.23.21.043.73.60.1573.23.40.253.63.50.1583.44.00.663.53.90.4594.04.10.173.93.90.0604.14.40.383.93.50.4614.44.40.093.54

20、.51.0624.43.70.7104.55.00.5633.74.40.7115.04.30.7644.44.70.3124.33.21.1654.73.51.2133.23.60.4663.54.20.7143.64.10.5674.24.40.2154.14.10.0684.44.00.4164.14.00.1694.04.80.8174.04.70.7704.83.71.1184.74.40.3713.75.11.4194.43.41.0725.14.11.0203.43.10.3734.14.10.0213.14.11.0744.13.90.2224.14.10.0753.94.80

21、.9234.13.20.9764.84.40.4243.23.30.1774.43.70.7253.33.80.5783.74.60.9263.84.50.7794.63.61.0274.54.20.3803.63.30.3284.23.40.8813.33.20.1293.45.11.7823.23.80.6305.14.30.8833.84.10.3314.34.20.1844.13.30.8324.24.10.1853.33.60.3334.14.90.8863.64.20.6344.94.10.8874.24.20.0354.13.60.5884.24.30.1363.63.60.08

22、94.34.00.3373.63.80.2904.03.80.2383.83.40.4913.83.40.4393.44.30.9923.43.40.0404.33.50.8933.44.61.2413.53.80.3944.63.70.9423.84.10.3953.73.80.1434.13.90.2963.83.80.0443.93.60.3973.83.60.2453.64.30.7983.63.80.2464.34.80.5993.83.20.6474.83.90.91003.23.30.1483.94.00.11013.33.80.5494.04.80.81023.83.80.05

23、04.84.00.81033.83.80.0514.04.50.51043.84.00.2524.54.80.31054.0/534.84.50.3/計(jì)算平均移動(dòng)極差（即這104個(gè)值的平均值） =0.498移動(dòng)極差R控制圖繪制： CLR=0.498 UCLR= D4=3.270.498=1.63 LCLR= D3=0系數(shù)D3和D4的值按n=2行查表得，由于該移動(dòng)極差圖已呈現(xiàn)出統(tǒng)計(jì)控制狀態(tài)，于是可進(jìn)行單值控制圖的繪圖。單值X控制圖繪制： CLX=3.98 UCLX =+ E2=+ 2.66=3.98+2.660.498=5.31 LCLX =- E2=- 2.66=3.98-2.660.498=

24、2.66采用n2，查表知E2=2.66。該控制圖表明過(guò)程處于統(tǒng)計(jì)控制狀態(tài)。2.5.3用成品溶檢驗(yàn)結(jié)果繪制控制圖。序號(hào)數(shù)據(jù)序號(hào)數(shù)據(jù)序號(hào)數(shù)據(jù)序號(hào)數(shù)據(jù)序號(hào)數(shù)據(jù)X126X2426X4726X7025X9325X233X2526X4829X7124X9420X325X2630X4929X7226X9528X426X2726X5030X7336X9625X525X2825X5130X7438X9728X626X2926X5220X7540X9825X726X3030X5326X7625X9925X825X3130X5428X7730X10026X932X3230X5520X7820X10130X1026X

25、3330X5625X7928X10225X1134X3426X5725X8026X10320X1235X3526X5829X8128X10426X1332X3625X5925X8220X10525X1433X3726X6025X8325/X1526X3830X6126X8423/X1626X3930X6225X8530/X1733X4025X6323X8630/X1835X4130X6426X8725/X1925X4230X6526X8825/X2035X4330X6626X8925/X2125X4430X6725X9025/X2226X4525X6826X9128/X2326X4625X69

26、27X9226/計(jì)算平均值為=27.15；計(jì)算移動(dòng)差距R值如下表：新的子群連續(xù)的對(duì)子移動(dòng)差距R新的子群連續(xù)的對(duì)子移動(dòng)差距R12633754282082332585520255325261562525042625157252945252615829254626260592525072625160252618253276126251932266622523210263486323263113435164262601235323652626013323316626251143326767252611526260682627116263376927252173335270252411835251071

27、242621925351072263610203525107336382212526174384022226260754025152326260762530524262607730201025263047820288263026479282622726251802628228252618128208292630482202553030300832523231303008423307323030085303003330264863025534262608725250352625188252503625261892525037263049025283383030091282623930255922

28、6251402530593252054130300942028842303009528253433030096252834430255972825345252509825250462526199252614726293100263044829290101302554929301102252055030300103202665130201010426251522026610525/5326282/計(jì)算平均移動(dòng)極差（即這104個(gè)值的平均值） =3.106移動(dòng)極差R控制圖繪制： CLR=3.106 UCLR= D4=3.273.095=10.2 LCLR= D3=0系數(shù)D3 和D4 的值按n=2行查

29、表得，由于該移動(dòng)極差圖已呈現(xiàn)出統(tǒng)計(jì)控制狀態(tài)，于是可進(jìn)行單值控制圖的繪圖。單值X控制圖繪制： CLX=27.15 UCLX =+ E2=+ 2.66=27.15+2.663.106=35.4 LCLX =- E2=- 2.66=27.15-2.663.106=18.9采用n2，查表知E2=2.66。該控制圖表明過(guò)程處于統(tǒng)計(jì)控制狀態(tài)2.5.4用成品含量檢驗(yàn)結(jié)果繪制控制圖。序號(hào)數(shù)據(jù)序號(hào)數(shù)據(jù)序號(hào)數(shù)據(jù)序號(hào)數(shù)據(jù)序號(hào)數(shù)據(jù)X18.0X246.1X476.9X708.0X938.6X26.3X254.4X487.4X719.0X948.7X37.3X264.7X497.2X729.0X957.7X47.6X27

30、4.8X509.5X739.4X969.1X56.6X286.6X518.8X749.8X978.2X67.1X297.0X527.9X758.9X988.8X78.0X307.5X538.1X769.6X998.6X87.0X316.5X547.8X778.6X1008.5X96.3X326.9X557.2X789.4X1019.3X109.4X338.2X568.5X798.2X1028.4X117.4X347.0X579.1X8010.1X1037.8X127.1X356.6X588.9X819.8X1047.8X138.0X367.2X598.2X829.9X1058.6X148.1X

31、377.1X607.7X8310.9/X157.3X387.3X616.5X848.6/X166.6X397.2X627.0X8510.3/X177.1X408.9X636.7X8611.4/X185.5X419.7X647.7X879.9/X196.4X427.9X658.3X888.6/X207.3X438.4X669.2X899.4/X215.8X447.2X678.5X908.2/X227.1X458.9X688.9X918.2/X235.9X467.3X699.5X928.7/計(jì)算平均值為=7.96；計(jì)算移動(dòng)差距R值如下表：新的子群連續(xù)的對(duì)子移動(dòng)差距R新的子群連續(xù)的對(duì)子移動(dòng)差距R18

32、.06.31.7547.87.20.626.37.31.0557.28.51.337.37.60.3568.59.10.647.66.61.0579.18.90.256.67.10.5588.98.20.767.18.00.9598.27.70.578.07.01.0607.76.51.287.06.30.7616.57.00.596.39.43.1627.06.70.3109.47.42.0636.77.71.0117.47.10.3647.78.30.6127.18.00.9658.39.20.9138.08.10.1669.28.50.7148.17.30.8678.58.90.4157

33、.36.60.7688.99.50.6166.67.10.5699.58.01.5177.15.51.6708.09.01.0185.56.40.9719.09.00.0196.47.30.9729.09.40.4207.35.81.5739.49.80.4215.87.11.3749.88.90.9227.15.91.2758.99.60.7235.96.10.2769.68.61.0246.14.41.7778.69.40.8254.44.70.3789.48.21.2264.74.80.1798.210.11.9274.86.61.88010.19.80.3286.67.00.4819.

34、89.90.1297.07.50.5829.910.91.0307.56.51.08310.98.62.3316.56.90.4848.610.31.7326.98.21.38510.311.41.1338.27.01.28611.49.91.5347.06.60.4879.98.61.3356.67.20.6888.69.40.8367.27.10.1899.48.21.2377.17.30.2908.28.20.0387.37.20.1918.28.70.5397.28.91.7928.78.60.1408.99.70.8938.68.70.1419.77.91.8948.77.71.04

35、27.98.40.5957.79.11.4438.47.21.2969.18.20.9447.28.91.7978.28.80.6458.97.31.6988.88.60.2467.36.90.4998.68.50.1476.97.40.51008.59.30.8487.47.20.21019.38.40.9497.29.52.31028.47.80.6509.58.80.71037.87.80.0518.87.90.91047.88.60.8527.98.10.21058.6/538.17.80.3/計(jì)算平均移動(dòng)極差（即這104個(gè)值的平均值） =0.8385移動(dòng)極差R控制圖繪制： CLR=0

36、.8385 UCLR= D4=3.270.8385=2.74 LCLR= D3=0系數(shù)D3 和D4的值按n=2行查表得，由于該移動(dòng)極差圖已呈現(xiàn)出統(tǒng)計(jì)控制狀態(tài)，于是可進(jìn)行單值控制圖的繪圖。單值X控制圖繪制： CLX=7.96 UCLX =+ E2=+ 2.66=7.96+2.660.8385=10.19 LCLX =- E2=- 2.66=7.96-2.660.8385=5.73采用n2，查表知E2=2.66。該控制圖表明過(guò)程處于統(tǒng)計(jì)控制狀態(tài)。2.5.5用成品甘草酸含量的檢驗(yàn)結(jié)果繪制控制圖。序號(hào)數(shù)據(jù)序號(hào)數(shù)據(jù)序號(hào)數(shù)據(jù)序號(hào)數(shù)據(jù)序號(hào)數(shù)據(jù)X13.9X234.2X455.2X675.1X894.6X24.

37、0X244.8X465.7X685.2X904.8X34.4X254.3X475.3X695.7X914.6X44.7X264.4X485.4X705.6X924.6X53.8X274.5X495.4X715.0X934.6X64.2X284.2X505.7X725.5X944.4X74.0X294.6X515.7X735.4X954.2X83.9X305.2X525.0X744.7X964.2X93.9X314.4X534.7X754.9X974.6X104.6X324.6X545.0X764.6X984.0X114.3X334.6X554.9X774.6X994.5X124.4X344.6

38、X565.6X785.0X1004.5X135.2X354.5X574.6X794.6X1014.4X144.2X363.8X584.4X804.8X1024.7X153.8X374.2X594.4X814.9X1035.0X164.5X384.2X604.6X824.9X1044.8X173.9X394.0X614.6X835.0X1054.6X184.2X404.8X624.6X845.0/X194.6X414.7X634.1X854.8/X203.8X425.1X644.9X865.2/X214.7X435.1X655.4X874.7/X224.9X445.2X665.6X884.6/計(jì)

39、算平均值為=4.68；計(jì)算移動(dòng)差距R值如下表：新的子群連續(xù)的對(duì)子移動(dòng)差距R新的子群連續(xù)的對(duì)子移動(dòng)差距R13.94.00.1545.04.90.124.04.40.4554.95.60.734.44.70.3565.64.61.044.73.80.9574.64.40.253.84.20.4584.44.40.064.24.00.2594.44.60.274.03.90.1604.64.60.083.93.90.0614.64.60.093.94.60.7624.64.10.5104.64.30.3634.14.90.8114.34.40.1644.95.40.5124.45.20.8655.4

40、5.60.2135.24.21.0665.65.10.5144.23.80.4675.15.20.1153.84.50.7685.25.70.5164.53.90.6695.75.60.1173.94.20.3705.65.00.6184.24.60.4715.05.50.5194.63.80.8725.55.40.1203.84.70.9735.44.70.7214.74.90.2744.74.90.2224.94.20.7754.94.60.3234.24.80.6764.64.60.0244.84.30.5774.65.00.4254.34.40.1785.04.60.4264.44.5

41、0.1794.64.80.2274.54.40.1804.84.90.1284.44.60.2814.94.90.0294.65.20.6824.95.00.1305.24.40.8835.05.00.0314.44.60.2845.04.80.2324.64.60.0854.85.20.4334.64.60.0865.24.70.5344.64.50.1874.74.60.1354.53.80.7884.64.60.0363.84.20.4894.64.80.2374.24.20.0904.84.60.2384.24.00.2914.64.60.0394.04.80.8924.64.60.0

42、404.84.70.1934.64.40.2414.75.10.4944.44.20.2425.15.10.0954.24.20.0435.15.20.1964.24.60.4445.25.20.0974.64.00.6455.25.70.5984.04.50.5465.75.30.4994.54.50.0475.35.40.11004.54.40.1485.45.40.01014.44.70.3495.45.70.31024.75.00.3505.75.70.01035.04.80.2515.75.00.71044.84.60.2525.04.70.31054.6/534.75.00.3/計(jì)

43、算平均移動(dòng)極差（即這104個(gè)值的平均值）=0.3125移動(dòng)極差R控制圖繪制： CLR=0.3125 UCLR= D4=3.270.3125=1.02 LCLR= D3=0系數(shù)D3和D4的值按n=2行查表得，由于該移動(dòng)極差圖已呈現(xiàn)出統(tǒng)計(jì)控制狀態(tài)，于是可進(jìn)行單值控制圖的繪圖。單值X控制圖繪制： CLX=4.68 UCLX=+ E2=+ 2.66=4.68+2.660.3125=5.51 LCLX=- E2=- 2.66=4.68-2.660.3125=3.85采用n2，查表知E2=2.66。該控制圖表明過(guò)程處于統(tǒng)計(jì)控制狀態(tài)。小結(jié)：本回顧年度內(nèi)生產(chǎn)的所有批次的性狀、鑒別、水分、裝量差異、溶散時(shí)限、微

44、生物限度、含量的檢驗(yàn)結(jié)果來(lái)看，均符合內(nèi)控標(biāo)準(zhǔn)，合格率達(dá)到100%，可以認(rèn)為在此工藝條件下生產(chǎn)出的產(chǎn)品均能達(dá)到產(chǎn)品的質(zhì)量標(biāo)準(zhǔn)。水分：內(nèi)控標(biāo)準(zhǔn)為不得過(guò)7.0%，回顧期限內(nèi)所有數(shù)據(jù)均符合內(nèi)控標(biāo)準(zhǔn)，平均值約為4.0%，合格率達(dá)到100%。從控制圖可以看出，各批數(shù)據(jù)基本在控制上線（UCL）與控制下線（LCL）之間，圖型分布也呈正常波動(dòng)狀態(tài)，認(rèn)為此工序?qū)λ值目刂铺幵谑芸貭顟B(tài)下，可以認(rèn)為在此工藝條件下所生產(chǎn)出的產(chǎn)品水分均能達(dá)到產(chǎn)品的質(zhì)量標(biāo)準(zhǔn)。溶散時(shí)限：內(nèi)控標(biāo)準(zhǔn)為50min，回顧期限內(nèi)所有數(shù)據(jù)均符合內(nèi)控標(biāo)準(zhǔn)，平均值約為27min，合格率達(dá)到100%。從控制圖可以看出，各批數(shù)據(jù)基本在控制上線（UCL）與控制下

45、線（LCL）之間，圖型分布也呈正常波動(dòng)狀態(tài)，認(rèn)為此工序?qū)θ苌r(shí)限的控制處在受控狀態(tài)下，可以認(rèn)為在此工藝條件下所生產(chǎn)出的產(chǎn)品溶散時(shí)限均能達(dá)到產(chǎn)品的質(zhì)量標(biāo)準(zhǔn)。薯蕷皂苷元含量：內(nèi)控標(biāo)準(zhǔn)為本品每1g含粉萆薢以薯蕷皂苷元計(jì)，不得少于4.2mg?；仡櫰谙迌?nèi)所有數(shù)據(jù)均符合內(nèi)控標(biāo)準(zhǔn)，平均值約為8.0mg，合格率達(dá)到100%。從控制圖可以看出，各批數(shù)據(jù)偶爾在控制上線（UCL）與控制下線（LCL）之外，可能是藥材產(chǎn)地不固定導(dǎo)致藥材含量不穩(wěn)定，最終導(dǎo)致成品含量的波動(dòng)。甘草酸含量：內(nèi)控標(biāo)準(zhǔn)為本品每1g含甘草以甘草酸計(jì)，不得少于3.7mg?；仡櫰谙迌?nèi)所有數(shù)據(jù)均符合內(nèi)控標(biāo)準(zhǔn)，平均值約為4.7mg，合格率達(dá)到100%。從控

46、制圖可以看出，各批數(shù)據(jù)偶爾在控制上線（UCL）與控制下線（LCL）之外，可能是藥材產(chǎn)地不固定導(dǎo)致藥材含量不穩(wěn)定，最終導(dǎo)致成品含量的波動(dòng)。3生產(chǎn)分析3.1關(guān)鍵工藝參數(shù)控制情況工序質(zhì)量控制點(diǎn)質(zhì)量控制項(xiàng)目頻次總混含量、鑒別、混合時(shí)間每批泛丸數(shù)量、加水量每批干燥干燥時(shí)間、溫度、水分隨時(shí)/每批包衣時(shí)間、粘合劑用量、丸重差異隨時(shí)包衣丸干燥時(shí)間、溫度、水分隨時(shí)/每批選丸外觀、丸重差異、鑒別、含量每批內(nèi)包裝外觀、裝量差異、密封性、微生物每批包裝小包裝說(shuō)明書、數(shù)量、批號(hào)隨時(shí)/每班中包裝數(shù)量、整齊隨時(shí)/每批大包裝數(shù)量、批號(hào)、裝箱單（合格證）隨時(shí)/每箱2012年度產(chǎn)品質(zhì)量回顧分析報(bào)告 01-2010編號(hào): 第44頁(yè)

47、，共53頁(yè)3.2產(chǎn)品各工序平衡率平衡率統(tǒng)計(jì)表批號(hào)總混物料平衡率(%)泛丸、干燥物料平衡率(%)選丸物料平衡率(%)包衣、干燥物料平衡率(%)擇丸物料平衡率(%)分裝物料平衡率(%)包裝物料平衡率(%)成品率（%）外包物料平衡率小盒（%）說(shuō)明書（%）檢封（%）紙箱（%）產(chǎn)品合格證（%）111201100.0099.16100.0098.8999.9699.8699.9695.00100.00100.00100.00100.00100.00111202100.0099.5699.9599.0899.9699.3399.9592.70100.00100.00100.00100.00100.00111

48、203100.0099.32100.0099.0099.9699.6499.9693.66100.00100.00100.00100.00100.00111204100.0099.3899.9599.60100.0099.0399.9694.40100.00100.00100.00100.00100.00111205100.0099.43100.0099.46100.0099.5999.9695.50100.00100.00100.00100.00100.0011120699.9599.89100.0099.2899.9799.2199.9695.26100.00100.00100.00100

49、.00100.00120101100.0099.46100.0099.21100.0098.2699.96103.46100.00100.00100.00100.00100.00120102100.0099.40100.0099.28100.0099.4199.96104.54100.00100.00100.00100.00100.00120201100.0099.38100.0098.7299.9698.8099.9586.04100.00100.00100.00100.00100.00120202100.0099.51100.0098.74100.0098.0899.9584.70100.

50、00100.00100.00100.00100.00120203100.0099.57100.0099.14100.0099.8999.9589.00100.00100.00100.00100.00100.00120204100.0098.94100.0098.8999.9699.0499.9584.20100.00100.00100.00100.00100.00120205100.0098.97100.0099.1099.9699.9699.9586.30100.00100.00100.00100.00100.00120206100.0098.75100.0099.1199.9698.909

51、9.9586.80100.00100.00100.00100.00100.00120207100.0099.3299.9598.5299.9698.2399.9583.90100.00100.00100.00100.00100.00120301100.0099.16100.0099.47100.0098.6999.9588.00100.00100.00100.00100.00100.00120302100.0099.29100.0099.26100.0098.0299.9587.86100.00100.00100.00100.00100.00120303100.0099.40100.0098.

52、9599.9699.2599.9586.64100.00100.00100.00100.00100.00120304100.0099.02100.0099.0799.9698.5299.9585.94100.00100.00100.00100.00100.00120305100.0099.35100.0099.07100.0099.0699.9587.40100.00100.00100.00100.00100.00120306100.0099.51100.0099.16100.0099.6199.9587.32100.00100.00100.00100.00100.00120307100.00

53、99.35100.0098.92100.0099.3699.9587.30100.00100.00100.00100.00100.00120308100.0099.21100.0098.94100.0099.6399.9587.58100.00100.00100.00100.00100.00120309100.0099.27100.0098.89100.0099.5799.9586.98100.00100.00100.00100.00100.00120310100.0099.21100.0099.05100.0099.2499.9585.38100.00100.00100.00100.0010

54、0.00120311100.0099.29100.0098.57100.0099.0199.9586.38100.00100.00100.00100.00100.00120312100.0099.35100.0099.18100.0099.0399.9586.44100.00100.00100.00100.00100.00120601100.0099.3599.9799.74100.0099.1999.9592.00100.00100.00100.00100.00100.00120602100.0099.73100.0099.65100.0095.2499.9586.46100.00100.0

55、0100.00100.00100.00120603100.0099.67100.0099.36100.0099.3099.9695.52100.00100.00100.00100.00100.00120604100.0098.80100.0099.74100.0099.6299.96101.00100.00100.00100.00100.00100.00120605100.0099.67100.0099.65100.0099.9199.9695.54100.00100.00100.00100.00100.00120606100.0099.46100.0099.80100.0099.1599.9

56、698.14100.00100.00100.00100.00100.00120607100.0099.62100.0099.61100.0098.1699.9590.58100.00100.00100.00100.00100.00120608100.0099.56100.0099.81100.0099.2599.96100.82100.00100.00100.00100.00100.00120701100.0099.40100.0099.74100.0098.8799.96101.00100.00100.00100.00100.00100.00120702100.0099.57100.0099

57、.81100.0099.9299.96101.00100.00100.00100.00100.00100.00120703100.0099.35100.0099.65100.0099.5199.96101.00100.00100.00100.00100.00100.00120704100.0099.40100.0099.61100.0099.2999.96101.00100.00100.00100.00100.00100.00120705100.0099.57100.0099.55100.0098.3499.96101.00100.00100.00100.00100.00100.0012070

58、6100.0099.40100.0099.65100.0099.9799.96103.40100.00100.00100.00100.00100.00120707100.0099.13100.0099.77100.0099.5399.96101.04100.00100.00100.00100.00100.00120708100.0099.40100.0099.81100.0099.2099.96101.04100.00100.00100.00100.00100.00120709100.0099.31100.0099.73100.0099.8599.9698.64100.00100.00100.

59、00100.00100.00120710100.0099.40100.0099.73100.0099.7599.9698.64100.00100.00100.00100.00100.00120711100.0099.49100.0099.21100.0099.8799.9698.64100.00100.00100.00100.00100.00120712100.0099.37100.0099.37100.0099.7399.9698.64100.00100.00100.00100.00100.00120801100.0098.97100.0099.30100.0099.6399.9698.64

60、100.00100.00100.00100.00100.00120802100.0098.74100.0099.27100.0099.8399.9696.24100.00100.00100.00100.00100.00120803100.0099.20100.0099.27100.0099.5199.9696.24100.00100.00100.00100.00100.00120804100.0098.97100.0099.47100.0099.8499.9696.30100.00100.00100.00100.00100.00120805100.0099.08100.0099.60100.0