TOP 9

QUALITY ASSURANCE & LAB ACCREDITATION

Control Charts

Accreditation of laboratories

Workshop ANKARA TOP 9 Quality

6./7.Dec 2011 1
Assurance - Control Charts
 TOP 9

QUALITY ASSURANCE & LAB ACCREDITATION

Control Charts

Accreditation of laboratories

Workshop ANKARA TOP 9 Quality

6./7.Dec 2011 2
Assurance - Control Charts
Trueness and precision -
systematic and stochastic errors

3
 Terms related to precision

• Trueness = accuracy = accuracy of the mean

• Precision
Repeatability - within laboratory - short term
Intermediate precision - within laboratory – long term
Reproducibility - between laboratories

The objective is to produce results which are true and precise

Workshop ANKARA 6./7.Dec 2012 - TOP 9 Quality 4

Assurance - Control Charts
Topic information about:
• Trueness = accuracy systematic error
• Precision stochastic errors
Repeatability precision of 1 sample,
1 lab technician, 1 analyzer,
identical reagents, same day
à „standard situation
mean of 2 – 4 results“
Intermediate precision of 1 sample, however
precision more variations within lab
e.g. control chart
Reproducibility 1 sample, >2 tester , >2 laboratories

Workshop ANKARA 6./7.Dec 2012 - TOP 9 Quality 5

Assurance - Control Charts
 Control chart
• Principal tool for internal quality control
• Analyse a number of routine samples
and control samples
• Normally one control value for each batch is entered to
the control chart
• most common: X-charts
control-limits: statistical à standard deviation
central line: mean value

Workshop ANKARA 6./7.Dec 2012 - TOP 9 Quality 6

Assurance - Control Charts
Control Chart

previous period
parameter: Lead (Pb)
matrix: Grassmeal Control Chart
1,50
Date mg/kg
Parameter: Pb Matrix: Grassmeal
1 1,07
2 0,89 1,30

3 0,94
4 0,92
1,10
5 0,87

m g/kg
6 1,10
7 0,97 0,90

20 0,88
0,70
mean 0,9620

standard deviation 0,0873

0,50
2*std dev. 0,1747 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 2 21 2 2 2 2 2 2 2 2 3 31

Date of analysis
3*std dev. 0,2620

Limits
lower warning limit 0,7873
upper warning limit 1,1367
lower control limit 0,7000
upper control limit 1,2240

Workshop ANKARA 6./7.Dec 2012 - TOP 9 Quality 7

Assurance - Control Charts
 Control limits
Control Chart
1,50
Parameter: Pb Matrix: Grassmeal

1,30

upper control limit +3 s

1,10
upper warning limit + 2 s
mg/kg

mean
0,90

lower warning limit - 2s

0,70 lower control limit - 3s

0,50
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 2 21 2 2 2 2 2 2 2 2 3 31

Date of analysis

Workshop ANKARA 6./7.Dec 2012 - TOP 9 Quality 8

Assurance - Control Charts
 Daily interpretation

There are 3 possible cases:

1) The method is in control

2) The method is in control but the long-term
evaluation shows that the method is
out of statistical control
3) The method is out of control

Workshop ANKARA 6./7.Dec 2012 - TOP 9 Quality 9

Assurance - Control Charts
 In-control-situation
Control Chart
parameter: Pb matrix: Grassmeal

1,50

1,30

1,10
mg/kg

0,90

0,70

0,50
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Date of analysis

• The control value is within the warning limits:

• the analyst can report the analytical results
• no further reactions

Workshop ANKARA 6./7.Dec 2012 - TOP 9 Quality 10

Assurance - Control Charts
 Control Chart
parameter: Pb matrix: Grassmeal

1,50

1,30

1,10
mg/kg

0,90

0,70

0,50
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Date of analysis

Workshop ANKARA 6./7.Dec 2012 - TOP 9 Quality 11

Assurance - Control Charts
 Control Chart
parameter: Pb matrix: Grassmeal

1,50

1,30

1,10
mg/kg

0,90

0,70

out of control
rule: „two out of three“ > 2 s
0,50
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Date of analysis

Workshop ANKARA 6./7.Dec 2012 - TOP 9 Quality 12

Assurance - Control Charts
Reaction, when „out of control-situation“

• Normally no analytical results can be reported

• All result since last value „in control“ was obtained

must be reanalysed

Workshop ANKARA 6./7.Dec 2012 - TOP 9 Quality 13

Assurance - Control Charts
 Control Chart
parameter: Pb matrix: Grassmeal

1,50

out of statistical control

1,30 7 * ascendend

1,10
mg/kg

0,90

0,70

0,50
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Date of analysis

Workshop ANKARA 6./7.Dec 2012 - TOP 9 Quality 14

Assurance - Control Charts
 Control Chart
parameter: Pb matrix: Grassmeal

1,50

out of statistical control

1,30
7 * descendend

1,10
mg/kg

0,90

0,70

0,50
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Date of analysis

Workshop ANKARA 6./7.Dec 2012 - TOP 9 Quality 15

Assurance - Control Charts
 Control Chart
parameter: Pb matrix: Grassmeal

1,50

out of statistical control

10 * above the mean value
1,30

1,10
mg/kg

0,90

Note:
0,70
Other recommendations:
7 * above the mean value
0,50
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Date of analysis

Workshop ANKARA 6./7.Dec 2012 - TOP 9 Quality 16

Assurance - Control Charts
 Control Chart
parameter: Pb matrix: Grassmeal

1,50

out of statistical control

1,30
10 * below mean value

1,10
mg/kg

0,90

0,70

0,50
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Date of analysis

Workshop ANKARA 6./7.Dec 2012 - TOP 9 Quality 17

Assurance - Control Charts
 Reaction, when
„out of statistical control“

• The analyst can report the analytical results

• But a problem may be developing
• Discover important trends as early as possible to
avoid serious problems
• Each laboratory has to decide in the quality manual
how to give attention to these trends
à generate standard operation procedures (SOPs)

Workshop ANKARA 6./7.Dec 2012 - TOP 9 Quality 18

Assurance - Control Charts
 Types of control charts

• X-Chart accuracy,
central line = mean-value
possible in X-Charts:
central line = nominal value (CRM)
• Range chart repeatability
relativ differences between duplicate analyzes
• Blank value chart contamination of reagents
• Recovery chart recovery, central line = 100 %

Workshop ANKARA 6./7.Dec 2012 - TOP 9 Quality 19

Assurance - Control Charts
 TOP 9

QUALITY ASSURANCE & LAB ACCREDITATION

Control Charts

Any Questions ?

Workshop ANKARA TOP 9 Quality

6./7.Dec 2011 20
Assurance - Control Charts