It is not that we would not react to a high or out of spec count. The question becomes what should the testing plan be? In the case of a pathogen, the area is cleaned immediately (at the presumptive report) and vector swabs to make sure the area is clean and it was just a spike. Additional finding triggers other steps.
But in the case of APC and EB I wouldn't break production to perform a clean on product contact and adjacent areas. We would reclean the area at next opportunity (likely at end of week) then we would swab no vectors), Does that seem urgent enough? What would be a good plan if the retest is also high?
Hi ddaniels,
Data such as APC, EB is typically associated with establishing the adequacy of Environmental-Process Hygiene, eg the Cleaning/Sanitizing Program. The latter should be a Prerequisite program where APC, etc data provide validation and verification.
Ideally the PRP/micro. verification aspect would be implemented within a daily Pre-operational program with a corrective action of investigation/immediate recleaning if failure of limits occurred. However the delay time for results from microbiological data exclude such an option. So the alternative is presumably asap+resampling which hopefully might be the next day, or two ?
PS - The verification data if significantly deviant would presumably also be analysed for potential implications to any parallel Pathogen monitoring scheme although these indicator programs are not generally regarded as having specific pathogen correlations.
The above is one reason why ATP is popular for enabling rapid hygiene-related decisions.
PPS - there are a variety of published EMPG programs in these posts -
https://www.ifsqn.co...ls/#entry100060
https://www.ifsqn.co...am/#entry119334
(I quite liked the relatively short AIB document for a quick appreciation of the general problem)
(env9 also has a quite interesting portion on corrective action logics mainly oriented to Listeria)
P3S - i assume the "enterobacter" in posts 1,2 are typos.