LABORATORY LABORATORY TESTINGTESTING QUALITY … · Comparing your CV h with Manufacturer’s CVs...

By Saranpat Khaongamdechawat

July 2, 2014

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Quality Result

LABORATORY LABORATORY LABORATORY LABORATORY LABORATORY LABORATORY LABORATORY LABORATORY TESTINGTESTINGTESTINGTESTINGTESTINGTESTINGTESTINGTESTING

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QUALITY QUALITY QUALITY QUALITY TEST RESULTTEST RESULTTEST RESULTTEST RESULT

Analytical processAnalytical processAnalytical processAnalytical process

Instrument4

Staff

Reagent

INTERNAL QUALITY CONTROL (IQC)INTERNAL QUALITY CONTROL (IQC)

Action of detecting error

Monitor

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Action of detecting error

ก��ก�� Error �� (Low detection error)Error �� (Low detection error) !ก"��กก� #$� Mean '() SD Leaflet ./�� "0�1

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SD '2�!ก"3��ก14��3(4��ก !ก"� False rejection 14�#8�!�9:!�(�'ก��.'()!ก"�2��#$��:!;"<.=>3

2SD3SD

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Mean Mean Mean Mean ±±±± 2222SDSDSDSD

RepeatRepeatRepeatRepeat

Minimum QualityMinimum QualityMinimum QualityMinimum Quality

Quality Control SituationQuality Control SituationQuality Control SituationQuality Control Situation

High High High High PPPPfrfrfrfr

SD limitSD limitSD limitSD limitToo narrowToo narrowToo narrowToo narrow

Buy new control Buy new control Buy new control Buy new control materialmaterialmaterialmaterial

Minimum QualityMinimum QualityMinimum QualityMinimum Quality

Maximum costMaximum costMaximum costMaximum cost

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QC chart control by traditional 2SD

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Negative Trend

Negative shift

ก�� QC QC QC QC �� ก��

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ANALYTICAL QCANALYTICAL QC

Internal Quality Control (IQC) Internal Quality Control (IQC) Internal Quality Control (IQC) Internal Quality Control (IQC) Internal Quality Control (IQC) Internal Quality Control (IQC) Internal Quality Control (IQC) Internal Quality Control (IQC)

External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)

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Requirements for IQC Chemistry

�Stable sample matrix

Internal Quality Control (IQC) Internal Quality Control (IQC)

�At least 2 concentration levels

�Established mean and SD range

�Levey-Jennings Charts

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Ex. Control 2 Levels

� 2 levels of quality control sera on 20 consecutive days.

How to set laboratory mean and SD? How to set laboratory mean and SD?

Internal Quality Control (IQC) Internal Quality Control (IQC)

� Calculate mean, SD

� Set in Levey-Jennings Charts

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Mean Mean Mean Mean ±±±± 2222SDSDSDSD

RepeatRepeatRepeatRepeat

In The Real !!!!In The Real !!!!In The Real !!!!In The Real !!!!

High High High High PPPPfrfrfrfr

SD limitSD limitSD limitSD limitToo narrowToo narrowToo narrowToo narrow

Buy new control Buy new control Buy new control Buy new control materialmaterialmaterialmaterial

Repeat QCRepeat QCRepeat QCRepeat QC

Recalibrate Test Recalibrate Test Recalibrate Test Recalibrate Test Buy new QC material Buy new QC material Buy new QC material Buy new QC material

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Establishing QC ranges using CVh

Test Glucose

QC Lot. 45652

Mean = 120.7

SD = 3.18

%CVh = 2.6

Current lot.

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%CVh = 2.6N = 553

Comparing your CVh with Manufacturer’s CVs and Peer CVs (EQA)

%CVh < Manufacturer

%CVh < %CV EQA

Establishing QC ranges using CVh

Test Glucose

QC Lot. 45652

%CVh = 2.6Current lot.

QC Lot. 45662

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QC Lot. 45662

Mean = 125.6

N = 20New lot.

SD = CVh /100 X Mean

= 2.6 / 100 X 125.6

SDNew = 3.26

Adopt in IQC ProgramNew establishing QC ranges :Mean = 125.6SD = 3.26

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1111. Single rule . Single rule . Single rule . Single rule

Ex. Ex. Ex. Ex. LeveyLeveyLeveyLevey----Jennings chart with control limits setJennings chart with control limits setJennings chart with control limits setJennings chart with control limits set

MEAN +/MEAN +/MEAN +/MEAN +/---- 2222SDSDSDSD

In or Out of Control ???????In or Out of Control ???????

MEAN +/MEAN +/MEAN +/MEAN +/---- 3333SD SD SD SD

2222. Multi. Multi. Multi. Multi----Rules QC Rules QC Rules QC Rules QC

uses uses uses uses 5 5 5 5 different control rules to judge the different control rules to judge the different control rules to judge the different control rules to judge the

acceptability of an analytical run. acceptability of an analytical run. acceptability of an analytical run. acceptability of an analytical run.

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MultiMulti--Rules ChartRules Chart

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The patient test results in this run can be reported.

12s

Warning RuleWarning Rule

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8�:�=�ก� �� ?(ก� 14� IQC ./�� 2��2C2CDE�;19<#$� )��!�9:�3�>3 (single control material) !H</?(3�>3/:I�3/ก mean ± 2SD

11113333ssss

�� ?(ก� 14� IQC ./�� 2��2C2CDE�;19<

Random ErrorRandom ErrorRandom ErrorRandom Error

./�� 2��2C2CDE�;19<#$� )��!�9:�3�>3 (single control material) !H</?(3�>3/:I�3/ก mean ± 3 SD

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22222222ssss

Systematic ErrorSystematic ErrorSystematic ErrorSystematic Error

� �� !H</?(ก� 14� IQC ./�� 2��2C2CDE�;19<#$� )��!�9:�3�>3 (single control material) �4�3�3 2 2 �>��"��/ก�3 9?(/:I�19< Mean + 2SD 8 H/ Mean N 2SD

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�� !H</?(ก� 14� IQC ./�� 2��2C2CDE�;19<#$� )��!�9:�ก�3 (Single control material) �4�3�3 2 2 �>� �"��/ก�3 9?(83=<�/:I�3/ก Mean + 1SD '()/9ก?(83=<�/:I�3/ก Mean N 1SD 8 H/#3(�ก0D)19<

RRRR4444ssss

Random ErrorRandom ErrorRandom ErrorRandom Error

83=<�/:I�3/ก Mean N 1SD 8 H/#3(�ก0D)19<14�#8�2�� 2 2 �>��ก�3 4SD

� �� 2��2C2CDE�;19<#$� 2 )�� (Two control material) 2�� )��' ก/:I�3/ก Mean + 1SD '()/9ก )��83=<�/:I�3/ก Mean N 1SD 8 H/#3(�ก0D)19<14�#8�2�� 2 2 �>��ก�3 4SD

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44441111ssss� �� !H</?(ก� 14� IQC ./��

2��2C2CDE�;19<#$� )��!�9:�ก�3 (Single control material) �4�3�3 4 2 �>� �"��/ก�3 9?(/:I�19< Mean + 1SD 8 H/ Mean N 1SD 8 H/#$�ก D919<#$�


8 H/ Mean N 1SD 8 H/#$�ก D919<#$�� 2��2C2CDE�;�/� )�� (Two control materials) '();��?( IQC 2 2 �>� �"��/ก�3./�� 2��2C2CDE�;'��() )��9?(/:I�19< Mean + 1SD 8 H/ Mean -1SD

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10101010xxxx �� !H</?(ก� 14� IQC ./�� 2��2C2CDE�;19<#$� )��!�9:�3�>3 (Single control material) �4�3�3 10 2 �>� �"��/ก�3 9?(/:I�19<��3#��383=<�./� Mean 8 H/#$�


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��3#��383=<�./� Mean 8 H/#$�#3ก D919<#$�� 2��2C2CDE�;�/� )�� (Two control materials) '();��?( IQC 5 2 �>��"��/ก�3./�� 2��2C2CDE�;'��() )�� 9?(/:I�19<��3#��383=<�./� Mean

2 of 32s เปนกฎที่ใชแสดงการ ปฏิเสธ เมื่อผลการทํา IQC ของสารควบคุมคุณภาพที่ใชสามระดับ (three control materials) จํานวน 2 ใน 3 ครั้ง มีผลอยูที่ mean + 2SD หรือ mean – 2SD


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mean – 2SD

31s เปนกฎที่ใชแสดงการ ปฏิเสธ เมื่อผลการทํา IQC ของสารควบคุมคุณภาพที่ใชสามระดับ (three control materials) จํานวน 3 ครั้ง ติดตอกัน มีผลอยูที่ mean + 1SD หรือ mean – 1SD

N = 3

6x เปนกฎที่ใชแสดงการ ปฏิเสธ เมื่อผลการทํา IQC ของสารควบคุมคุณภาพที่ใชสามระดับ (three control material) จํานวน 6 ครั้ง ติดตอกัน มีผลอยูที่ดานใดดานหนึ่งของ mean


N = 3

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9x เปนกฎที่ใชแสดงการ ปฏิเสธ เมื่อผลการทํา IQC ของสารควบคุมคุณภาพที่ใชสามระดับ (three control material) จํานวน 9 ครั้ง ติดตอกัน มีผลอยูที่ดานใดดานหนึ่งของ mean

N = 3

---- WarningWarningWarningWarning

• 11112222ssss

---- Systemic errorSystemic errorSystemic errorSystemic error

Summary Rules Chart

---- Systemic errorSystemic errorSystemic errorSystemic error

• 22222222ssss , , , , 2 2 2 2 of of of of 33332222s s s s , , , , 33331111ssss ,,,,44441111ssss, , , , 6666x , x , x , x , 9999x, x, x, x, 10101010xxxx

---- Random errorRandom errorRandom errorRandom error

• 11113333ssss , R, R, R, R4444ssss

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• ��ก�� ก mean , SD ��( %CV ��ก��

• ��ก�� ก,- Performance �� 3�� ก� ��(45 ��( Turn-around time

• 3�ก�� IQC ��3 ��(�� 3 �� >��,?�� ,��

3�ก��4��4�@�� out of control

ก��ก�� ก�� IQC (QC Records)

• 3�ก��4��4�@�� out of control

• ก��ก��BC4��ก��D?��(ก��3�

• �� Control material ��(��BC4��ก��D?�

• ��E �F � ก�-��@�,กG��>��H��ก,��BC4��,?�� I��(��ก�� ก�� 3��ก�� ก�� Calibrate �� Calibrator ��?��IF�I�ก�� K ��(ก��ก�� K�L�>��

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External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)External Quality Assessment (EQA)

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LabResult

EQA: SC

Result

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Requirements for EQARequirements for EQA

� Registration with EQA scheme organizers

� Different serum levels to cover patient range

EXTERNAL QUALITY ASSESSMENT (EQA)EXTERNAL QUALITY ASSESSMENT (EQA)EXTERNAL QUALITY ASSESSMENT (EQA)EXTERNAL QUALITY ASSESSMENT (EQA)EXTERNAL QUALITY ASSESSMENT (EQA)EXTERNAL QUALITY ASSESSMENT (EQA)EXTERNAL QUALITY ASSESSMENT (EQA)EXTERNAL QUALITY ASSESSMENT (EQA)

Different serum levels to cover patient range

� stable and consistent sample matrix

� matrix mimics patient samples

� samples assayed ‘blind’‘blind’

� frequent analysis

� rapid feedback

� user friendly reports EQAEQA�� AccuracyAccuracyEQAEQA�� AccuracyAccuracy

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Objective : Provides laboratories to monitorObjective : Provides laboratories to monitorObjective : Provides laboratories to monitorObjective : Provides laboratories to monitor

1111. LongLong--term precision and accuracy term precision and accuracy

EXTERNAL QUALITY ASSESSMENT (EQA)EXTERNAL QUALITY ASSESSMENT (EQA)EXTERNAL QUALITY ASSESSMENT (EQA)EXTERNAL QUALITY ASSESSMENT (EQA)EXTERNAL QUALITY ASSESSMENT (EQA)EXTERNAL QUALITY ASSESSMENT (EQA)EXTERNAL QUALITY ASSESSMENT (EQA)EXTERNAL QUALITY ASSESSMENT (EQA)

1111. LongLong--term precision and accuracy term precision and accuracy

22. Compare performance with other laboratories. Compare performance with other laboratories.

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EQA:SC

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VIS = [BIS]VIS = [BIS]VIS = [BIS]VIS = [BIS]

BIS = ( BIS = ( BIS = ( BIS = ( X X X X –––– DVDVDVDV ) x ) x ) x ) x 100 100 100 100 x x x x 100100100100

0 - 50 A51 - 100 B101-150 C> 151 Sus.Q

0 - 50 A51 - 100 B101-150 C> 151 Sus.Q

EQA:SC

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BIS = ( BIS = ( BIS = ( BIS = ( X X X X –––– DVDVDVDV ) x ) x ) x ) x 100 100 100 100 x x x x 100100100100

DVDVDVDV CCVCCVCCVCCV

X = Your resultX = Your resultX = Your resultX = Your result

DV = Designed Value(Mean)DV = Designed Value(Mean)DV = Designed Value(Mean)DV = Designed Value(Mean)CCV = CCV = CCV = CCV = ��ก��ก IEQAS IEQAS IEQAS IEQAS �� UK NEQAS UK NEQAS UK NEQAS UK NEQAS

> 151 Sus.Q> 151 Sus.Q

EQAHEQAHEQAHEQAHEQAHEQAHEQAHEQAH--------ThyroidThyroidThyroidThyroidThyroidThyroidThyroidThyroid

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RIQAS

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QUALITY REQUIREMENTQUALITY REQUIREMENTQUALITY REQUIREMENTQUALITY REQUIREMENT

�Quality requirement ��ก�� !�!ก "#$�%&& six sigma �*� Allowable total error (TEa)

� TEa �34��5� error �6��789 :;��<&=8$ >?:��34� error 9 :�ก!8@�กก��A!��%BC (Analytical) �95��<E�

�� TEa CLIATEa CLIATEa CLIATEa CLIA

Routine ChemistryRoutine ChemistryRoutine ChemistryRoutine Chemistry

Test or Test or Test or Test or AnalyteAnalyteAnalyteAnalyte Acceptable PerformanceAcceptable PerformanceAcceptable PerformanceAcceptable PerformanceAlanine aminotransferase Target value ± 20%

Albumin Target value ± 10%

Alkaline phosphatase Target value ± 30%

Amylase Target value ± 30%

Aspartate aminotransferase (AST) Target value ± 20%

Bilirubin, total Target value ± 0.4 mg/dL or ± 20% (greater)Bilirubin, total Target value ± 0.4 mg/dL or ± 20% (greater)

Calcium, total Target value ± 1.0 mg/dL

Chloride Target value ± 5%

Cholesterol, total Target value ± 10%

Cholesterol, high dens. lipoprotein Target value ± 30%

Creatine kinase Target value ± 30%

Creatine kinase isoenzymes MB elevated (present or absent) or Target value ± 3 SD

Creatinine

Creatinine Target value ± 0.3 mg/dL or ± 15% (greater)

GlucoseGlucoseGlucoseGlucose Target value Target value Target value Target value ±±±± 6 mg/6 mg/6 mg/6 mg/dLdLdLdL or or or or ±±±± 10% (greater)10% (greater)10% (greater)10% (greater)

https://www.westgard.com/clia.htm

ก��*�ก"#$ TEa F&& Absolute concentration limit B�*� Percent

Example : Glucose

TEa = 6.0 mg/dL

TEa = 10%

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�� GLUC 10 % ��-�� ก,- 100 %6.0 mg/dL ��-�� ก,- (6.0/10) x 100 = 60 mg/dL

( ��ก � 60 mg/dL IF� TEa = 6.0 mg/dL)

QC SpecificationQC SpecificationQC SpecificationQC Specification

� Probability Probability Probability Probability of error detection (Pof error detection (Pof error detection (Pof error detection (Pedededed) > ) > ) > ) > 0000....90909090

� Probability of false rejection (Probability of false rejection (Probability of false rejection (Probability of false rejection (PPPPfrfrfrfr) < ) < ) < ) < 0000....05050505 QC Rules

QC QC

QC Procedure QC Procedure QC Procedure QC Procedure ��ก��

Number of control (N)

Number of run (R)

QC QC ProcedureProcedure

QC PLANNING TOOLQC PLANNING TOOLQC PLANNING TOOLQC PLANNING TOOL

1. Sigma metric2. Operator specifications chart (OPSpec chart)2. Operator specifications chart (OPSpec chart)3. Commercial program

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Sigma metric calculationSigma metric calculationSigma metric calculationSigma metric calculation

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Sigma metric = [(TEa � Bias)/SD]

Sigma metric calculationSigma metric calculationSigma metric calculationSigma metric calculation

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Sigma metric = [(TEa � %bias)/%CV]

ExampleGlucose TEa = 6 mg/dL, 10%

Concentration cut off = (6/10 x 100) = 60 mg/dL

Statistic or Run Statistic or Run Statistic or Run Statistic or Run

DateDateDateDate

Glucose

L1: 45641 L2: 45642 L3: 45643

Current (Mean)Current (Mean)Current (Mean)Current (Mean) 59.7 116.2 346.2

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Current (SD)Current (SD)Current (SD)Current (SD) 0.84 1.53 4.49

Current (CV)Current (CV)Current (CV)Current (CV) 1.41 1.32 1.30

Bias -1.43

%Bias 2.59

Sigma (6-1.43)/0.84 (10-2.59)/1.32 (10-2.59)/1.30

Sigma 5.5 5.6 5.7

�5� Sigma QC Procedure

≥ 6 IF� N= 2 4�� N = 3 ��( control limit �� 3.0s 4�� 3.5s ��(�� ก 2S �>��I4� �`� ��(45�� Pfr ��

5 IF� N = 2 4�� N = 3 ��( Control limit �� 2.5s 4�� 3.0s ��ก 3.0s �� Sigma > 5 ��(��ก

QC Procedure by Rule of thumb

5 IF� N = 2 4�� N = 3 ��( Control limit �� 2.5s 4�� 3.0s ��ก 3.0s �� Sigma > 5 ��(��ก 2.5s �� Sigma < 5

4 IF� N = 4 4�� N=6 ��( Control limit �� multirule (13s/22s/R4s/41s) 4�� 2.5s >�K��IF� multi-rule ��ก��4�,� �� >��I4� � Ped �>��D?�

<4 IF� maximum QC procedure �� non-statistical QC procedures �� F �� preventive maintenance �� g�� functional check ��I4��D?� �� performance validation check ��(IF�3��j�-,�� F��C��กI�ก��ก� ��(45

<3 ��ก ��(45I4� 4��>,k��I4��D?�ก ��

�$�@J�ก<8�� Sigma metric

1. !"#$%&'(#&)*+ QC Specification (Ped ./0 Pfr) )*+1234ก&%126(%&078 9:;+<&"&%=>?!>@A&ก Sigma metric graph $4;<%@&+):BCA&กก&%DE@FG%.ก%"(*"H216I*%8<J&6%KA%?G$4;"4AJ&7C#&Lก&%DE@FG%.ก%"(*"H216I*%8<J&6%KA%?G$4;"4AJ&7C#&L

2. Analytical quality requirement $4;DE@A0!>@"&A&ก TEa 6$#&CSBC3. "4 Rules ./0 N D7@6/V*กC@*L4. W?@DE@I@*+"4)@*"?/./0$SกX0 6HV;*$4;A0G%06"2C method performance

characteristics ./0I@*+"4(?#"V*ก&%DE@+&C./0I@*+.Lก!1@ES>6AC

Christian H.H. Schoenmakers, Andre J.M. Naus, Henricus J. Vermeer, Douwe van Loon and Gerard Steen

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��ก�� QC Planning ?CREm

No. Lab C

1 1.002 1.0

2 1.093 1.1

3 1.044 1.0

4 1.079 1.1

5 1.031 1.0

6 1.082 1.1

7 1.031 1.0

8 1.048 1.0

9 1.074 1.1

10 1.045 1.0

11 1.063 1.1

12 1.038 1.0

13 1.033 1.0

14 1.028 1.0

�$��6� IQC �%8<&9 : 1 ��ก��A!��%BC Creatinine

�$��6� precision 9 :� @789N�!;� 1 �J�FB�5� 13s / 2of3 2s / R4s / 31s Sigma metric = 4.414 1.028 1.0

15 1.081 1.1

16 1.011 1.0

17 1.037 1.0

18 0.991 1.0

19 1.051 1.1

20 1.028 1.0

Max 1.093 1.1

Min 0.991 1

Max-Min 0.102 0.1

Mean 1.04 1.04

SD 0.03 0.05

CV 2.64 4.73

TEa 0.3 0.3

%Bias 0.08 0.08

Sigma 7.8 4.4

13s / 2of3 2s / R4s / 31s Sigma metric = 4.4

�$��6�9 :=8$@�ก@789N�!;� 2 �J�FB�5�13S Sigma metric = 7.8

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Quality control planningQuality control planningQuality control planningQuality control planning

OPSpec chart (OPSpec chart (OPSpec chart (OPSpec chart (8 8 8 8 Steps)Steps)Steps)Steps)

Define quality required for diagnostic test

Assess method

Evaluate rejection characteristics

Select control rules, Assess method performance

Prepare OPSpec chartPrepare OPSpec chartPrepare OPSpec chartPrepare OPSpec chart

Plot operating pointPlot operating pointPlot operating pointPlot operating point

Adopt Total QC StrategyAdopt Total QC StrategyAdopt Total QC StrategyAdopt Total QC Strategy

Select control rules, number of measurements

Reassess for changesReassess for changesReassess for changesReassess for changes

Normalized OPSpec ChartNormalized OPSpec ChartNormalized OPSpec ChartNormalized OPSpec Chart

1. Quality Requirement

3.

-Rejection characteristics

2. Precision and Accuracy observed for a method

characteristics for difference control rules (Pfr)-Number control of measurement (N)-Number of run (R)

NormalizationNormalizationNormalizationNormalization

� �34�ก��F3��5� %Imprecision F�% %Inaccuracy �9 ;&ก<&�5� TEa F�$AF3��5��ก��34��3��C�>P��C

� �Q*:�9 :��R�J��5�=3 Plot "� OPSpecs Chart U8;� �Q*:�9 :��R�J��5�=3 Plot "� OPSpecs Chart U8;��*�ก OPSpecs Chart 9 :�B��%��9 :�78�J�B�<& Test �<E�V

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� ก��F3��5� %Imprecision F�% %Inaccuracy

� A!W ก��J��AX �<A�;5�� Test Glucose � TEa = 10 %

Normalized Imprecision

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สูตร = %CV/TEa x 100

Normalized Inaccuracy

สูตร = %Bias/TEa x 100

ตัวอยาง Test Glucose มี TEa = 10 %

Normalized ImprecisionNormalized ImprecisionNormalized ImprecisionNormalized Imprecision



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= %CV/TEa x 100

= 1.59/10 x 100

= 15.9 ( แกน X )

Normalized InaccuracyNormalized InaccuracyNormalized InaccuracyNormalized Inaccuracy


= 0.19/10 x 100

= 1.9 ( แกน Y )

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Normalize OPSpec Chart (N=2 and N=4)

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Normalize OPSpec Chart (N=3 and N=6)N=3 and 90% AQA

N=6 and 90% AQA

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N=3 and 50% AQA

N=6 and 50% AQA

Normalize OPSpec Chart

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90% AQA, N=3


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50% AQA, N=3


90% AQA, N=6


50% AQA, N=6


ตัวอยาง Test Glucose มี TEa = 10 %

Normalized ImprecisionNormalized ImprecisionNormalized ImprecisionNormalized Imprecision



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= %CV/TEa x 100

= 1.59/10 x 100

= 15.9 ( แกน X )

Normalized InaccuracyNormalized InaccuracyNormalized InaccuracyNormalized Inaccuracy


= 0.19/10 x 100

= 1.9 ( แกน Y )


= 15.9 ( แกน X )

Normalized Inaccuracy

= 1.9 ( แกน Y )

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((((15151515....9 9 9 9 , , , , 1111....9999))))

เลือก Control Rules

โดยเลือกจากเสนที่อยูเหนือ Operating Point และ False Rejection นอยๆ (ไมเกิน 5% หรือ 0.05)

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((((15151515....9 9 9 9 , , , , 1111....9999))))

� ��ก��@�`5�� total quality control strategy (TQC strategy) �-- LO-Ped strategy (Low error detection) r��IF� maximum QC ��, F �K,- error ��ก 13S /2 of 3 2S/R4S/31S/6X N=6

I4� ��,C��ก�� non statistic QC procedure I4��ก�D?� ��ก � I4� ��,C��ก�� non statistic QC procedure I4��ก�D?� ��ก ก�IF� optimize QC process stability, ก�IF�3��j�-,��F��C��( ก�IF� patient data QC

�8�A�� :;��5�ก��;��\�ก��A!��%BC\!8Q��8

3�%U;#�C"�ก��9J� QC planning

Quality control

��&��5�3]^B�9 :�ก!8�?E�=8$R6ก�$�� A8��PA

#5A;�Q!:�ก��9J� quality control=8$�;5�� 3�%�!9W!_�Q

�8�&3�%��X�5�"#$@5�;"�ก��9J� quality control

Quality control planning

LABORATORY LABORATORY TESTINGTESTING QUALITY … · Comparing your CV h with Manufacturer’s CVs...

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Transcript of LABORATORY LABORATORY TESTINGTESTING QUALITY … · Comparing your CV h with Manufacturer’s CVs...