Specifications

45
• variance homogenity according
to Bartlett.
Lab capability
Knowledge of lab capability is neces-
sary for accurate estimates of
process capability (see DIN 55350
parts 33 and 11). It checks for the
ratio of result dispersion versus
specifications. Lab capability occu-
pies a special position among
Validation concepts because it does
not exclusively refer to the analytical
method. Figure 29 shows the plan-
ning dialog of checkpoint “linearity”
Planning data
• Number of samples
• Y-units
• Lower specification
• Upper specification
• Calculation of Xb where Xb is
the reference value such as an
analytical result value defined
as ideal
• Multiple injection possible
Output settings for calculations
No output settings can be configured
by the user. For lab capability, the
indices Cm and Pm are defined anal-
ogous to Cp. Cmk and Pmk are
defined analogous to Cpk. The result
calculates all indices along with the
specification limits and a judgement
if lab capability is low, medium or
high.
Figure 28
Planning dialog of checkpoint “Robustness/Ruggedness”
Figure 29
Planning dialog of checkpoint “Lab Capability”