標準物質監控
1.1 質控過程
通tong常chang的de做zuo法fa是shi實shi驗yan室shi直zhi接jie用yong合he適shi的de有you證zheng標biao準zhun物wu質zhi或huo內nei部bu標biao準zhun樣yang品pin作zuo為wei監jian控kong樣yang品pin,定ding期qi或huo不bu定ding期qi將jiang監jian控kong樣yang品pin以yi比bi對dui樣yang或huo密mi碼ma樣yang的de形xing式shi,與yu樣yang品pin檢jian測ce以yi相xiang同tong的de流liu程cheng和he方fang法fa同tong時shi進jin行xing,檢jian測ce室shi完wan成cheng後hou上shang報bao檢jian測ce結jie果guo給gei相xiang關guan質zhi量liang控kong製zhi人ren員yuan,也ye可ke由you檢jian測ce人ren員yuan自zi行xing安an排pai在zai樣yang品pin檢jian測ce時shi同tong時shi插cha人ren標biao準zhun物wu質zhi,驗yan證zheng檢jian測ce結jie果guo的de準zhun確que性xing。
1.2 適用範圍
一般可用於:儀器狀態的控製、樣品檢測過程的控製、實驗室內部的儀器比對、人員比對、方法比對以及實驗室間比對等。這種方法的特點是可靠性高,但成本高。
人員比對
2.1 質控過程
youshiyanshineibudejiancerenyuanzaihelideshijianduannei,duitongyiyangpin,shiyongtongyifangfa,zaixiangtongdejianceyiqishangwanchengjiancerenwu,bijiaojiancejieguodefuhechengdu,pandingjiancerenyuancaozuonenglidekebixinghewendingxing。shiyanshijinxingrenyuanbidui,biduixiangmujinkenengjiancehuanjiefuzayixie,youqishishoudongcaozuobuzhouduoyixie。jiancerenyuanzhijiandecaozuoyaoxianghuduli,bimianxianghuzhijiancunzaiganrao。tongchangqingkuangxia,shiyanshizaijiandupincishangduixinshanggangrenyuandejiandugaoyuzhengchangzaigangrenyuan,qiezaizuzhirenyuanbiduishizuihaoshizhongyibenshiyanshijingyanfengfuhenengliwendingdejiancerenyuansuobaojieguoweicankaozhi。
2.2 適用範圍
實驗室內部組織的人員比對,主要目的是評價檢測人員是否具備上崗或換崗的能力和資格,因此,主要用於考核新進人員、新培訓人員的檢測技術能力和監督在崗人員的檢測技術能力兩個方麵。
方法比對
方fang法fa比bi對dui是shi不bu同tong分fen析xi方fang法fa之zhi間jian的de比bi對dui試shi驗yan,指zhi同tong一yi檢jian測ce人ren員yuan對dui同tong一yi樣yang品pin采cai用yong不bu同tong的de檢jian測ce方fang法fa,檢jian測ce同tong一yi項xiang目mu,比bi較jiao測ce定ding結jie果guo的de符fu合he程cheng度du,判pan定ding其qi可ke比bi性xing,以yi驗yan證zheng方fang法fa的de可ke靠kao性xing。方fang法fa比bi對dui的de考kao核he對dui象xiang為wei檢jian測ce方fang法fa,主zhu要yao目mu的de是shi評ping價jia不bu同tong檢jian測ce方fang法fa的de檢jian測ce結jie果guo是shi否fou存cun在zai顯xian著zhu性xing差cha異yi。比bi對dui時shi,通tong常chang以yi標biao準zhun方fang法fa所suo得de檢jian測ce結jie果guo作zuo為wei參can考kao值zhi,用yong其qi他ta檢jian測ce方fang法fa的de檢jian測ce結jie果guo與yu之zhi進jin行xing對dui比bi,方fang法fa之zhi間jian的de檢jian測ce結jie果guo差cha異yi應ying該gai符fu合he評ping價jia要yao求qiu,否fou則ze,即ji證zheng明ming非fei標biao方fang法fa是shi不bu適shi用yong的de,或huo者zhe需xu要yao進jin一yi步bu修xiu改gai、優化。
3.2 適用範圍
fangfabiduizhuyaoyongyukaochabutongdejiancefangfazhijiancunzaidexitongwucha,jiankongjiancejieguodeyouxiaoxing,qiciyeyongyuduishiyanshishejidefeibiaofangfadequeren。zhengtidejiancefangfayibanbaokuoyangpinqianchulifangfaheyiqifangfa,zhiyaoqianchulifangfabutong,buguanyiqifangfashifouxiangtong,douguileiweifangfabidui。danshi,ruguobutongdejiancefangfazhongyangpindeqianchulifangfaxiangtong,jinshijianceyiqishebeibutong,yibanjiangqiguileiweiyiqibidui。
儀器比對
4.1 質控過程
儀器比對是指同一檢測人員運用不同儀器設備(包括儀器種類相同或不同等),對dui相xiang同tong的de樣yang品pin使shi用yong相xiang同tong檢jian測ce方fang法fa進jin行xing檢jian測ce,比bi較jiao測ce定ding結jie果guo的de符fu合he程cheng度du,判pan定ding儀yi器qi性xing能neng的de可ke比bi性xing。儀yi器qi比bi對dui的de考kao核he對dui象xiang為wei檢jian測ce儀yi器qi,主zhu要yao目mu的de是shi評ping價jia不bu同tong檢jian測ce儀yi器qi的de性xing能neng差cha異yi(如靈敏度、精密度、抗幹擾能力等)、測定結果的符合程度和存在的問題。所選擇的檢測項目和檢測方法應該能夠適合和充分體現參加比對的儀器的性能。
4.2 適用範圍
yiqibiduitongchangyongyushiyanshiduixinzenghuoweixiuhouyiqishebeidexingnengqingkuangjinxingdehezhakongzhi,yekeyongyupingguyiqishebeizhijiandejiancejieguodechayichengdu。jinxingyiqibidui,youqiyaozhuyibaochibiduiguochengzhongchuyiqizhiwaiqitasuoyouhuanjietiaojiandeyizhixing,yiquebaojieguochayiduiyiqixingnengdechongfenxiangying。
留樣複測
5.1 質控過程
留樣複測是指在不同的時間(合理的時間間隔內),再次對同一樣品進行檢測,通過比較前後兩次測定結果的一致性來判斷檢測過程是否存在問題,驗證檢測數據的可靠性和穩定性。
若2次檢測結果符合評價要求,則說明實驗室該項目的檢測能力持續有效;ruobufuhe,yingfenxiyuanyin,caiqujiuzhengcuoshi,biyaoshizhuisuqianqidejiancejieguo。shishishang,liuyangfucekeyirenweishiyizhongteshudeshiyanshineibubidui,jibutongshijiandebidui。liuyangfuceyingzhuyisuoyongyangpindexingnengzhibiaodewendingxing,jiyingyouchongfendeshujuxianshihuojingzhuanjiapinggu,biaomingliucundeyangpinfuzhiwending。
5.2 適用範圍
留樣複測作為內部質量控製手段,主要適用於:有一定水平檢測數據的樣品或陽性樣品、待檢測項目相對比較穩定的樣品以及當需要對留存樣品特性的監控、檢測結果的再現性進行驗證等。采取留樣複測有利於監控該項目檢測結果的持續穩定性及觀察其發展趨勢;yekecushijianyanrenyuanrenzhenduidaimeiyicijianyangongzuo,congertigaozishensuzhihejishushuiping。danyaozhuyidaoliuyangfucezhinengduijiancejieguodezhongfuxingjinxingkongzhi,bunengpanduanjiancejieguoshifoucunzaixitongwucha。
空白測試
6.1 質控過程
空白測試又稱空白試驗,是在不加待測樣品(特殊情況下可采用不含待測組分,但有與樣品基本一致基體的空白樣品代替)的情況下,用與測定待測樣品相同的方法、步bu驟zhou進jin行xing定ding量liang分fen析xi,獲huo得de分fen析xi結jie果guo的de過guo程cheng。空kong白bai試shi驗yan測ce得de的de結jie果guo稱cheng為wei空kong白bai試shi驗yan值zhi,簡jian稱cheng空kong白bai值zhi。空kong白bai值zhi一yi般ban反fan映ying測ce試shi係xi統tong的de本ben底di,包bao括kuo測ce試shi儀yi器qi的de噪zao聲sheng、試劑中的雜質、環huan境jing及ji操cao作zuo過guo程cheng中zhong的de沾zhan汙wu等deng因yin素su對dui樣yang品pin產chan生sheng的de綜zong合he影ying響xiang,它ta直zhi接jie關guan係xi到dao最zui終zhong檢jian測ce結jie果guo的de準zhun確que性xing,可ke從cong樣yang品pin的de分fen析xi結jie果guo中zhong扣kou除chu。通tong過guo這zhe種zhong扣kou除chu可ke以yi有you效xiao降jiang低di由you於yu試shi劑ji不bu純chun或huo試shi劑ji幹gan擾rao等deng所suo造zao成cheng的de係xi統tong誤wu差cha。
6.2 適用範圍
實驗室通過做空白測試,一方麵可以有效評價並校正由試劑、實驗用水、器皿以及環境因素帶人的雜質所引起的誤差;lingyifangmianzaibaozhengduikongbaizhijinxingyouxiaojiankongdetongshi,yenenggouzhangwobutongfenxifangfahejiancerenyuanzhijiandechayiqingkuang。ciwai,zuokongbaiceshi,hainenggouzhunquepinggugaijiancefangfadejianchuxianhedingliangxiandengjishuzhibiao。
重複測試
7.1 質控過程
重zhong複fu測ce試shi即ji重zhong複fu性xing試shi驗yan,也ye稱cheng為wei平ping行xing樣yang測ce試shi,指zhi的de是shi在zai重zhong複fu性xing條tiao件jian下xia進jin行xing的de兩liang次ci或huo多duo次ci測ce試shi。重zhong複fu性xing條tiao件jian指zhi的de是shi在zai同tong一yi實shi驗yan室shi,由you同tong一yi檢jian測ce人ren員yuan使shi用yong相xiang同tong的de設she備bei,按an相xiang同tong的de測ce試shi方fang法fa,在zai短duan時shi間jian內nei對dui同tong一yi被bei測ce對dui象xiang相xiang互hu獨du立li進jin行xing檢jian測ce的de測ce試shi條tiao件jian。
7.2 適用範圍
重複測試可以廣泛地用於實驗室對樣品製備均勻性、檢測設備或儀器的穩定性、測試方法的精密度、jiancerenyuandejishushuipingyijipingxingyangjiandefenxijiangedengjinxingjiancepingjia。xuyaozhuyideshi,suizhedaicezufenhanliangshuipingdebutong,jianceguochengzhongduiceshijingmidukenengchanshengzhongyaoyingxiangdeyinsuhuiyouhendabutong。
回收率試驗
8.1 質控過程
回收率試驗也稱“加標回收率試驗”,通tong常chang是shi將jiang已yi知zhi質zhi量liang或huo濃nong度du的de被bei測ce物wu質zhi添tian加jia到dao被bei測ce樣yang品pin中zhong作zuo為wei測ce定ding對dui象xiang,用yong給gei定ding的de方fang法fa進jin行xing測ce定ding,所suo得de的de結jie果guo與yu已yi知zhi質zhi量liang或huo濃nong度du進jin行xing比bi較jiao,計ji算suan被bei測ce物wu質zhi分fen析xi結jie果guo增zeng量liang占zhan添tian加jia的de已yi知zhi量liang的de百bai分fen比bi等deng一yi係xi列lie操cao作zuo。該gai計ji算suan的de百bai分fen比bi即ji稱cheng該gai方fang法fa對dui該gai物wu質zhi的de“加標回收率”,簡稱“回收率”。通常情況下,回收率越接近100%,定量分析結果的準確度就越高,因此可以用回收率的大小來評價定量分析結果的準確度。
8.2 適用範圍
huishoulvshiyanjuyoufangfacaozuojiandan,chengbendiliandetedian,nengzonghefanyingduozhongyinsuyinqidewucha,zaijianceshiyanshirichangzhiliangkongzhizhongyoushifenzhongyaodezuoyong,zhuyaoshiyongfanweibaokuo:各類化學分析中,如各類產品和材料中低含量重金屬、有機化合物等項目檢測結果控製、化學檢測方法的準確度、可靠性的驗證、化學檢測樣品前處理或儀器測定的有效性等。
校準曲線的核查
9.1 質控過程
校(xiao)準(zhun)曲(qu)線(xian)是(shi)用(yong)於(yu)描(miao)述(shu)待(dai)測(ce)物(wu)質(zhi)濃(nong)度(du)或(huo)量(liang)與(yu)檢(jian)測(ce)儀(yi)器(qi)相(xiang)應(ying)值(zhi)或(huo)指(zhi)示(shi)值(zhi)之(zhi)間(jian)的(de)定(ding)量(liang)關(guan)係(xi)。通(tong)過(guo)使(shi)用(yong)標(biao)準(zhun)溶(rong)液(ye)按(an)照(zhao)正(zheng)常(chang)樣(yang)品(pin)檢(jian)測(ce)程(cheng)序(xu)作(zuo)簡(jian)化(hua)或(huo)完(wan)全(quan)相(xiang)同(tong)的(de)分(fen)析(xi)處(chu)理(li),而(er)繪(hui)製(zhi)得(de)到(dao)的(de)校(xiao)準(zhun)曲(qu)線(xian)則(ze)相(xiang)應(ying)稱(cheng)為(wei)標(biao)準(zhun)曲(qu)線(xian)和(he)工(gong)作(zuo)曲(qu)線(xian)。為(wei)確(que)保(bao)校(xiao)準(zhun)曲(qu)線(xian)始(shi)終(zhong)具(ju)有(you)良(liang)好(hao)的(de)精(jing)密(mi)度(du)和(he)準(zhun)確(que)度(du),就(jiu)需(xu)要(yao)采(cai)取(qu)相(xiang)應(ying)的(de)方(fang)法(fa)進(jin)行(xing)核(he)查(zha)。對(dui)精(jing)密(mi)度(du)的(de)核(he)查(zha),通(tong)常(chang)在(zai)校(xiao)準(zhun)曲(qu)線(xian)上(shang)取(qu)低(di)、中、高3個濃度點進行驗證。對準確度的核查,通常采用加標回收率試驗的方法進行控製。
9.2 適用範圍
校(xiao)準(zhun)曲(qu)線(xian)法(fa)是(shi)實(shi)驗(yan)室(shi)儀(yi)器(qi)分(fen)析(xi)中(zhong)經(jing)常(chang)采(cai)用(yong)的(de)方(fang)法(fa),通(tong)常(chang)待(dai)測(ce)樣(yang)品(pin)組(zu)分(fen)濃(nong)度(du)波(bo)動(dong)較(jiao)大(da),且(qie)樣(yang)品(pin)批(pi)量(liang)較(jiao)大(da)。而(er)在(zai)檢(jian)測(ce)過(guo)程(cheng)中(zhong)采(cai)用(yong)的(de)校(xiao)準(zhun)曲(qu)線(xian)的(de)精(jing)密(mi)度(du)和(he)準(zhun)確(que)度(du)會(hui)受(shou)到(dao)實(shi)驗(yan)室(shi)的(de)檢(jian)測(ce)條(tiao)件(jian)、檢測儀器的響應性能、檢測人員的操作水平等多種因素的影響。定期的核查一方麵可以驗證儀器的響應性能、檢測人員的操作規範穩定程度等,另一方麵也可以同時得到繪製曲線時所用標準溶液的穩定性核查信息。
質量控製圖
10.1 質控過程
為wei控kong製zhi檢jian測ce結jie果guo的de精jing密mi度du和he準zhun確que度du,通tong常chang需xu要yao在zai檢jian測ce過guo程cheng中zhong,持chi續xu地di使shi用yong監jian控kong樣yang品pin進jin行xing檢jian測ce控kong製zhi。對dui積ji累lei的de監jian控kong數shu據ju進jin行xing統tong計ji分fen析xi,通tong過guo計ji算suan平ping均jun值zhi,極ji差cha,標biao準zhun差cha等deng統tong計ji量liang,按an照zhao質zhi量liang控kong製zhi圖tu的de製zhi作zuo程cheng序xu,確que定ding中zhong心xin線xian,上shang、下控製限,以及上、下輔助線和上、下(xia)警(jing)戒(jie)線(xian),從(cong)而(er)繪(hui)製(zhi)出(chu)分(fen)析(xi)用(yong)控(kong)製(zhi)圖(tu)。通(tong)過(guo)分(fen)析(xi)用(yong)控(kong)製(zhi)圖(tu),判(pan)斷(duan)測(ce)量(liang)過(guo)程(cheng)處(chu)於(yu)穩(wen)定(ding)或(huo)控(kong)製(zhi)狀(zhuang)態(tai)後(hou),就(jiu)可(ke)以(yi)將(jiang)分(fen)析(xi)用(yong)控(kong)製(zhi)圖(tu)轉(zhuan)換(huan)為(wei)控(kong)製(zhi)用(yong)控(kong)製(zhi)圖(tu),並(bing)將(jiang)日(ri)常(chang)測(ce)定(ding)的(de)控(kong)製(zhi)數(shu)據(ju)描(miao)點(dian)上(shang)去(qu),判(pan)斷(duan)是(shi)否(fou)存(cun)在(zai)係(xi)統(tong)變(bian)異(yi)或(huo)趨(qu)勢(shi)。
10.2 適用範圍
質量控製圖適用於如下範圍:
①當希望對過程輸出的變化範圍進行預測時;
②當判斷一個過程是否處於統計受控狀態時;
③當分析過程變異來源是隨機性還是非隨機性時;
④當決定怎樣完成一個質量改進項目時一防止特殊問題的出現,或對過程進行基礎性的改變;
⑤當希望控製當前過程,問題出現時能察覺並對其采取補救措施時。
---想了解更多資訊,歡迎關注“藥物微生物檢驗”公眾號!---
---客服電話: 李老師 (微信同號)---
手機版




