OQ and PQ exams should really bear in mind the geometry from the sample (e.g. condition and dimensions of the container, and distance into the sensitive area in the detector). Re-qualification plan of dose calibrators should really account that day by day checks (e.g. constancy tests) tend to be done, and in addition verification of linearity and r

Control limits should not be bewildered with tolerance limits or requirements, which can be entirely impartial on the distribution with the plotted sample statistic. Control limits explain what a system is capable of manufacturing (from time to time called the “voice of the process”), when tolerances and specs explain how the product must accom