Dear All,
All the test pieces are significantly smaller than the sizes quoted as being injurious to health.
With all due respect, this is somewhat selective quoting. The linked article has caveats, eg consumer, and the USFDA related document (from memory) has further details. Not sure how well this data is accepted outside USA ?
Some authorities apparently simply choose to be conservative since the technical capability (arguably) readily exists, eg Belgium (?).
Some auditors are apparently quite happy to go along with the upper values quoted.
The net result is that a variety of acceptable critical limits exists. Spice of Life.
I have never had an auditor challenge my (sensitivity) selection of 2-3 mm "wands" or "spheres". IMEX most auditors do not demand the exhaustive "calibration" procedures as contained within, say, the Tesco manifesto, impressive though they undoubtedly are (eg shea quays elegant post #6).
IMO it is "reasonably" well accepted (eg Codex 2008, et al) that for certain processes, a MD does not have to be a
CCP, either conceptually or by risk assessment.
As per George's last paragraph, the MD's continuing popularity as a
CCP is surely due to customers, auditors and a tree. And in some cases, the potential auditorial embarrassment of a process with no
CCP.
Rgds / Charles.C