Addressing
the hesitancy and the potential paradox
nStructured development information and robust estimates of variability
n
nFor this approach the
pivotal clinical trial lot(s) must be “stable” (and capable) and its variation understood to
the extent that units may
be sampled (e.g., stratified plan) for a “destructive” Gauge R&R study
n
nContribution to an
improved assurance of quality over what
we achieve today
n