QUALITY CONTROL CHART
MAB ASIH
25 NOV 2016
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ISO/IEC 17025:2005
Clause 5.9
The laboratory shall have quality control procedures for
monitoring the validity of tests and calibrations
undertaken. The resulting data shall be recorded in such
a way that trends are detectable and, where practicable,
statistical techniques shall be applied to the reviewing
of results. This monitoring shall be planned and
reviewed and may include regular use of internal quality
controlQuality control data shall be analysed and,
where they are found to be outside pre-defined criteria,
planned action shall be taken to correct the problem and
to prevent incorrect results from being reported.
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Control Charts
Powerful and simple tool for the daily quality
control of routine analytical work [1].
Visual tool used to aid in tracking laboratorys
performance
Graphical plot of test results with respect to time
or sequence of measurements with limits drawn
within which results are expected to lie
Demonstrate that the measurement procedure
performs within the given limits [1].
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Types of Control Charts
Shewhart Chart
- used to monitor the precision of mean values
from multiple analyses or of single results [2]
- can be applied in different forms: mean value
control chart, blank value control chart, recovery
rate chart
-based on distribution of the control values
around expected value [1]
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Types of Control Charts
R-charts and standard deviation charts
- allows detection of significant differences
between the standard deviation of the subgroups
[2]
- serves above all the purpose of repeatability
control
Cusum charts
Target value charts
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Types of Control Charts
Type of calculations Suitable for Required
control chart detecting analyses
Shewhart Mean value and Gross errors, Control sample
Chart standard systematic errors, analyses
deviation random errors,
generally for
precision control
Range Chart Mean range, Imprecision At least two
standard determinations
deviation, range for actual
from the control samples at
analyses established
intervals
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Types of Control Charts
Type of calculations Suitable for Required
control chart detecting analyses
Cusum Chart Reference value Inaccuracy, drift Control sample
and standard analyses at
deviation; setting established
the leading intervals
distance and half
angles of V-mask;
calculation of the
cumulative sum
Target Value Specified limits Inaccuracy or Depends on the
Chart Imprecision required task
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Shewhart Chart
Decision Criteria or Out-of-Control Situations
1 point outside the control limit (3SD)
2 out of 3 consecutive points outside the warning
limit (2SD)on the same side of the center line
4 out of 5 consecutive points outside or more
than 1SD on the same side of the center line
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Shewhart Chart
Decision Criteria or Out-of-Control Situations
9 successive points are on the same side of the
center line
6 consecutive points, increasing or decreasing
trend
14 consecutive points alternating up and down
15 consecutive points within 1SD on either side
of the center line
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Range Chart
Decision Criteria or Out-of-Control Situations
1 point outside the upper control limit
1 point lies below the lower control limit
(valid if LCL > 0)
6 consecutive points increasing or decreasing
trend
7 consecutive points lie above the range mean
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Exercise
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Exercise
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References
1. Nordtest Report TR 569 (2011), Internal Quality Control
Handbook for Chemical laboratories.
2. Funk, W., Dammann, V., Donnevert, G., Quality Assurance in
Analytical Chemistry 2nd ed.
3. Food and Agriculture Organization of the United Nations
(1998), Guidelines for Quality Management in Soil and Plant
Laboratories .
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