2016-05-18 1 Setting the requirements for a method (including aspects of MU) Bertil Magnusson, SP Technical Research Institute of Sweden For a validation study we need to have several requirements… Target uncertainty Measurand Robustness Sample types Precision Trueness (bias) Measurement range Focus on these 3 performance characteristics 2
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Setting the requirements for a method (including aspects of MU) … · 2016-05-18 · 2016-05-18 1 Setting the requirements for a method (including aspects of MU) Bertil Magnusson,
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2016-05-18
1
Setting the requirements for a method (including aspects of MU)
Bertil Magnusson, SP Technical Research Institute of Sweden
For a validation
study we need
to have several
requirements…Target
uncertaintyMeasurand Robustness
Sample types Precision Trueness (bias)Measurement range
Focus on these 3 performance characteristics
2
2016-05-18
2
Measurement cycle Requirements Comparing Process control
SpecificationTranslate
requirements
With clear and
distinct requirements
on an analytical
method we can
assess fitness for
purpose
0
1
2
3
4
5
6
Legal limits
3
Measurement cycle
4
2016-05-18
3
The whole method validation process
“from the customer problem
to the laboratory decision
on whether or not the customer request
can be carried out with an identified method”
Text cited From Eurachem Guide Fitness for purpose of