Self test 10

Robustness and ruggedness indicate the analytical method performance during the small variations in mass spectrometric conditions (cleanliness of the MS source, changes in the voltages, etc).

Robustness and ruggedness indicate the analytical method performance during the small variations in the environmental conditions (season, weather, room temperature, air humidity, etc).

Robustness and ruggedness indicate the analytical method performance during the small variations in chromatography (mobile phase composition, column age, column temperature, etc).

Robustness and ruggedness are evaluated only during the changes within the same laboratory.

In validation guidelines terms robustness and ruggedness are considered to have the same meaning.

When used together in the guidelines, robustness and ruggedness are considered to be synonyms. 

Robustness and ruggedness are the same as decision threshold, detection capacity and measurement uncertainty.

Robustness should be used as a parameter characterizing the stability of the method with respect to variations of the internal factors (parameters) of the method.

Ruggedness should be used as a parameter evaluating constancy of the results when external factors are changed.