Část: rozhodování o shodě se - web.vscht.czkocourev/files/qa_decision-print.pdf ·...
TRANSCRIPT
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Kvalita v laboratorn a kontroln praxist: Rozhodovn o shod se
specifikac (limitem)
Praha, 2017
Vladimr Kocourek
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Shoda se specifikac / limitem
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Posuzovn shody se specifikac / limitem
Clem men / analzy bv zskat objektivn data pro rozhodnout o pijet nebo zamtnut hypotzy o shod s pedpisem: ANO - NE.
je zkuebn metoda vhodn pro zamlen el ?
je laborato (analytick systm) schopna danou metodou generovat spolehliv vsledky ?
Pracovn charakteristiky zjitn validac (pesnost, detekn schopnost, selektivita,.)
Nejistoty, prokzn nvaznosti, dkaz zpsobilosti, dvra v systm managementu akreditace
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Rozhodovn o shod se specifikac (limitem) Y
Skutenost
X = Y (S) X Y (N)
Hypotza(rozhodnut)
H
Nulov H0X = Y
O.K.Pijet H0
Zamtnut H1(1- )
FalenNegativn - chyba II.
druhu
Alternativn
H1X Y
FalenPozitivn -chyba I.
druhu
O.K.Zamtnut H0
Pijet H1
?
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Rozhodovn o shod se specifikac
Pravdiv stav
NEJSOU JSOU
Vsledek analzy
(hypotza)
H
Nulov H0NEJSOU
(shoda)
O.K.Pijet H0
Zamtnut H1(1- )
Falen Negativn
- chyba II. druhu
Alternativn
H1JSOU
(neshoda)
Falen Pozitivn
-chyba I. druhu
O.K.Zamtnut H0
Pijet H1
Jsou ve vzorku mlka antibiotika ?
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Rozhodovn o shod s vyuitm hodnoty nejistoty
Guidelines on the Reporting of Compliance with Specification. ILAC-G8:03/2009
Vyhovuje ? 2 ? 3 Nevyhovuje
Horn limit
Ppad 2 a 3: nen mon prohlsit SHODU
International Laboratory Accreditation Cooperation
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Rozhodovn o shod s vyuitm hodnoty nejistoty
Je-li dosaena shoda se specifikac, mlo by bt zkaznkovi jasn, jak pravdpodobnost pokryt pro rozenou nejistotu byla pouita. Obecn bude pravdpodobnost pokryt 95 % a vyjden bude obsahovat poznmku ve smyslu, e Vyjden shody je zaloeno na pravdpodobnosti pokryt 95 % pro rozenou nejistotu....
ILAC-G8:03/2009Pokyny k uvdn shody se specifikac
Jakkoli jin hodnoty pravdpodobnosti pokryt pro rozenou nejistotu by mly bt dohodnuty mezi laborato a zkaznkem.
Pro rozenou nejistotu mohou bt zvoleny vy pravdpodobnosti pokryt ne 95 % (nap. 99 %), ni hodnoty by nemly bt pouvny.
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Rozhodovn o shod s vyuitm hodnoty nejistoty ILAC-G8:03/2009Pokyny k uvdn shody se specifikac
Pro horn mez specifikace (max. limit) je doporuen nsledujc pstup:
(a) Shoda: Jestlie max. limit nen pekroen vsledkem menzvtenm o rozenou nejistotu s pravdpodobnost 95 %.
Mono vyjdit jako Shoda nebo Vyhovuje, bere-li se v vahu nejistotamen.
(b) Neshoda: Jestlie je max. limit pekroen vsledkem menzmenenm o rozenou nejistotu s pravdpodobnost 95 %.
Mono vyjdit jako Neshoda nebo Nevyhovuje, bere-li se v vahu nejistota men.
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(c) Jestlie bude vsledek men zvten/zmenen o rozenou nejistotu pekrvat mezn hodnotu, pak nen mon vyjdit shodu nebo neshodu. Vsledek men a rozen nejistota by pak ml bt uveden spolu s vyjdenm naznaujcm, e nebyla prokzna ani shoda, ani neshoda.
Vhodn vyjden by bylo Nen mon vyjdit shodu.
Pokud je vsledek je pod limitem, pipout se vyjden jako Nen mon vyjditshodu za pouit pravdpodobnosti pokryt 95 % pro rozenou nejistotu,pestoe vsledek men se nachz pod mezn hodnotou. Pokud budou uvdna krat vyjden, tak by nemla vzbuzovat dojem, e je dan vsledek ve shod se specifikac.
Rozhodovn o shod s vyuitm hodnoty nejistoty
ILAC-G8:03/2009Pokyny k uvdn shody se specifikac
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Odbr a analza vzorku
Pijet nebo Odmtnut
Posuzovn shody s poadavkem obecn princip
Materil (produkt, poloka)
Vsledek U (k=2) Specifikace / limit Rozhodovac pravidla
Pedpisy (legislativa, norma, smlouva ,
Nelze rozhodnout, e se nerozhodneme
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EURACHEM Guide 2007, resp. ISO 10576-1:2004
L - maximln limit; DLs doln rozhodovac limit
DLh horn rozhodovac limit
u kombinovan nejistota vsledku
- hladina vznamnosti; chyba I.
DLs = L k *u DLh = L + k *u
pro = 0,05 (5 %) je jednostrann k = 1,64
DLs = L 1,64*u DLh = L + 1,64*u
Nejistota vsledku m rozhodujc vliv na vpoet DL!
Rozhodovac pravidla
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L
u u
L-1,64*u L+1,64*u
u ...standardn nejistota
VYHOVUJE NEVYHOVUJE
Maximln vsledek men nutn pro zvr e s 95%n pravdpodobnost NEBYL pekroen maximln limit
Minimln vsledek men nutn pro vrok, e s 95%n pravdpodobnost
BYL pekroen maximln limit
ed zna
5 %5 %
Rozhodovac pravidla
Graf1
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List1
Standardised normal distribution
z1f(z)z2
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List1
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2
2
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2
z
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p
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=
221().2zfze
MBD00017C57.unknown
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Oblasti pijet a odmtnut
oblast specifikace
Reject
Limit
oblast pijmut oblast odmtnut
DLs DLh
pechodov oblast
pravdpodobnost odmtnut > 95 %
pravdpodobnostpijmut > 95 %
Accept
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Pklad:
Maximln limit je 10 ppm, standardn nejistota vsledku je 1,0 ppm a je vokol limitn hodnoty nezvisl na obsahu. Pro hodnoty vsledk men jednotlivch ar vrobku:
8,0 9,5 10,0 10,5 12,0zjistte soulad s hypotzou o nepekroen maximlnho limitu s chybou I. druhu = 0,05 (5 %).
DLs = 10 1,64*1,0 = 8,36 ppm
DLh = 10 + 1,64*1,0 = 11,64 ppm
Hodnota 8,0 je v oblasti pijet, hodnota 12,0 je v oblasti odmtnut. Ostatn namen hodnoty spadaj do pechodov oblasti a nememe s jistotou ci, zda spluj hypotzu.
Oblasti pijet a odmtnut
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Pklad:
Rozen nejistota vsledku na hladin 10 g/kg se uvd U = 4 g/kg.
1. Jak by musel bt vsledek v protokolu o zkoukch, aby bylo mono s jistotou (> 95 %) tvrdit, e NEBYL pekroen limit 10 g/kg ?
2. Jak by musel bt vsledek v protokolu o zkoukch, aby bylo mono s jistotou (> 95 %) tvrdit, e BYL pekroen limit 10 g/kg ?
standardn nejistota u = U/2 = 4/2 = 2 g/kg
DLs = 10 1,64*2 = 6,72 g/kg; DLh = 10 + 1,64*1 = 13,28 g/kg
Oblasti pijet a odmtnut
Zvr - pi dan nejistot vsledku je:jistota (> 95 % pravdpodobnost) e limit NEBYL pekroen plat
jen pro hodnoty < 6,7 g/kg. V tto oblasti je riziko pevzet neshodn dodvky pro odbratele nzk (pod 5 %), kvalita je zaruena. jistota, e limit BYL pekroen je a pro hodnoty 13,3 g/kg a vy.vsledky mezi 6,7 a 13,3 g/kg neumouj rozhodnout s jistotou a riziko pro odbratele stoup od cca 5 % pi 6,7 g/kg a do 95 % pi 13,3 g/kg. Kvalita tedy pro vsledky nad 6,7 ppb nen dostaten prokzna (zaruena) !
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Kriteria podle rozhodnut Komise 2002/657/ES
CC odezva s danou chybou (nap. 5 %) a 50 % chybou
CC odezva s velmi malou chybou a danou chybou (nap. 5 %)
sPL scont
L DL = CC CC detekn schopnost
u
Men rozhodovac meze CC na rovni maximlnho limitu L:
Rozhodovac pravidla
1,64*u 1,64*u
-
DL = L + k *upro = 0,05 (5 %), k = 1,64
pro = 0,01 (1 %), k = 2,33
pro = 0,001 (0,1 %), k = 3,09
Kriteria podle rozhodnut Komise 2002/657/ES
Loblast
specifikace DL
oblast pijmut oblast odmtnutNon-conformity - rejectConformity - accept
CC
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Dvoustupov test shody
Pokud vsledek zkouky pekrauje maximln limit, zahj se opakovan vyeten za elem potvrzen dve zskanho vsledku. Vsledek zkouky je pak prmrem vsledk nejmn dvou soubnch stanoven, nen-li stanoveno jinak.
Doporuen praxe pi kontrole potravin:
Pokud maximln limit le uvnit intervalu nejistoty vsledku, provede se opakovan cel zkouky a s pihldnutm k obma vsledkm se stanov konen vsledek a nejistota.
Pokud maximln limit stle le uvnit intervalu nejistoty vsledku, je test neprkazn (nelze prohlsit shodu ani neshodu).
+ vt pravdpodobnost prohlen shody u skuten shodnch vzork (TP),- vt pravdpodobnost prohlen shody u skuten NEshodnch vzork (FN)
SN ISO 10576-1 hodnocen shody se specifikovanmi poadavky:
-
Pklad:
vdsko: limit L pro alkohol v krvi idie: 0,2 g/kg, tj. 0,2 .
daj je doprovzen informac, e v 0,1% testovanch osob me test ukzat, e nevyhovuj limitu i kdy ve skutenosti mu vyhovuj ( chyba = 0,001).
Nejistota vsledku testu byla odhadnuta pro koncentrace blzk legislativnmu limitu a m hodnotu u = 0,0065 g/kg.
= 0,001, k = 3,09
DL = 0,2 + 3,09*0,0065 = 0,22
Interpretace: Vzorek krve, u kterho se nam obsah alkoholu
0,22 g/kg (0,22 ) a ni ne je vyhovujc.
Rozhodovac pravidla edn kontrola
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Vydno: Executive Board WADA (World Anti-Doping Agency) - 2010
Limitn hodnoty pro nkter zakzan ltky
Vpoet rozhodovacho limitu DL pro posouzen, zda je 95 % (nebo 99 %) pravdpodobnost pouit zakzan ltky
Nejistota, nen-li zskna jinak, me bt odhadnuta z Horwitzovy rovnice jako RSDR
RSDR(%) = 2^(1-0.5*log c)Pro c < 1 g/ml pouito RSDr = 2/3 RSDR
DL = L + k*RSDr(%)/100
pro = 0,05 (5 %), k = 1,64pro = 0,01 (1 %), k = 2,33
Rozhodovac pravidla dopingov testy
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Limity a rozhodovac limity: nkter zakzan ltky (doping-WADA)Rozhodovac pravidla
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Mic schopnost, LOD (signlov domna)
blanky
blanks
= 5 % = 5 %
1,64*sblank 1,64*sblank
Rozhodovac pravidla na hranici mitelnosti
Signl analytuOdezva blank
YLOD = CC
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Sttn zdravotn stav (Nrodn referenn centrum pro pitnou vodu) - stanovisko ke zohlednn nejistoty men pi hodnocen vsledk rozbor pitn vody:
Pi hodnocen vsledk rozboru vody se prost porovnv namen hodnota se stanovenm hygienickm limitem, nejistota se pro rozhodnut o dodren limitu nezohleduje.
Ppad B: vsledek pevyuje limitn hodnotu, ta se vak nachz v intervalu nejistoty men
Ppad C: vsledek je ni ne limitn hodnota, ta se vak nachz v intervalu nejistoty men
Mon vyjden k vsledkm:
Nmecko - Nazen o pitn vod: Limitn hodnoty stanoven tmto Nazenm zohleduj nejistotu men metody analzy a odbru vzork.
Kdyby se akceptovalo odetn nejistoty od hodnoty vsledku, vznikla by situace, e mezi dodavateli vody by se staly nejdanj ty laboratoe, kter vykazuj nejvt nejistotu men, tedy ty nejmn kvalitn.
Kvalita v laboratorn a kontroln praxi st: Rozhodovn o shod se specifikac (limitem)Snmek slo 2Snmek slo 3Snmek slo 4Snmek slo 5Snmek slo 6Snmek slo 7Snmek slo 8Snmek slo 9Snmek slo 10Snmek slo 11Snmek slo 12Snmek slo 13Snmek slo 14Snmek slo 15Snmek slo 16Snmek slo 17Snmek slo 18Snmek slo 19Snmek slo 20Snmek slo 21Snmek slo 22Snmek slo 23