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What are the acceptance criteria/requirements for Stability Study?

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Bev D

Heretical Statistician
Staff member
Super Moderator
#7
Stability for measurement systems is all about determining if the measurement error changes over time. 'Time" can be elapsed time (for example some biological assays will degrade in signal over time) or it might be time to time changes in conditions such as humidity or temperature.

The risk of not doing the study is that you would miss understanding how your measurement error is effected by the above factors and then can lead to incorrect decisions from the system. The severity of those risks involves knowledge of the thing the system is measuring and the severity of the effect(s) of an incorrect decision. The probability of these failures can only be determined by performing the study...
 

Miner

Forum Moderator
Staff member
Admin
#8
Can someone tell me what is the acceptance criteria/requirement for Stability Study? Thank you
Stability studies for measurement devices are usually performed using a control chart, so the criteria for acceptance is that all measurements are in a state of control.
 
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