Gauge Study Question

jpanhalt

Joined Jan 18, 2008
11,087
That is an interesting compilation of the process. I am not sure I agree with this condition:
The measurements should be made by a single operator
under all circumstances. That is, assuming you are selling just the gauge and not the operator too.:D What type of gauge are you interested in testing?

If one generalizes on the concept of a gauge just a little, some additional considerations are found in the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988, USA) in the sections having to do with test and instrument validation. Be sure to get a current copy with all its revisions. That regulation took a very tortuous path to implementation. There are also resources at the Clinical Laboratory Standards Institute (http://www.clsi.org/) and the International Organization for Standardization (http://www.iso.org/iso/home.html).

Some of the additional testing and validation procedures I consider important are:
1) Testing must be over the entire calibrated/reporting range of the gauge/instrument.
2) Linearity must be assessed. Calibration, re-calibration, and calibration verification procedures may depend on whether the instrument/gauge is linear or not.
3) If the gauge/instrument is used to detect a particular condition, say the presence of a particular drug in urine or bacterial contamination of a production lot of intravenous fluids, then testing must include real samples that are known to be positive or negative by other methods. The statistics can get challenging when the condition being tested for happens rarely.

John
 

VoodooMojo

Joined Nov 28, 2009
505
That is an interesting compilation of the process. I am not sure I agree with this condition: (Quote:The measurements should be made by a single operator) under all circumstances. That is, assuming you are selling just the gauge and not the operator too.:D What type of gauge are you interested in testing?
John
I thought that meant the operator had to be unmarried
 
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