I have a "what would you do" for the group - recently, a truck was received with an ingredient that was found to have coliforms outside of the tolerance on the certificate of analysis (100cfu/g over the limit). The truck was unloaded prior to this issue being found, so the supplier is now saying that if it didn't meet our specifications, it shouldn't have been received.
The ingredient was quarantined, per facility SOP and then a senior manager made the decision to release it for use. We have steps in our process that will kill any pathogens, but they aren't recognized as CCPs in the HACCP plan.
So, my question is this - what would you do? Push back on the senior manager? The supplier? Our COAs get reviewed, but typically aren't seen by a "qualified individual" until the truck has already been unloaded and is long gone. <-- this is being addressed with training and procedural revisions.
Any help or regulatory guidelines would be greatly appreciated.
Good morning Charles.C!
I'll bet the "C" stands for "Concise", which I was not in my original post. The coliform specification on the ingredient in question is <500cfu/g, but the shipment received came in at 600cfu/g. The main concern for me is that it's outside the agreed upon specification, which is listed on the supplier's COA.
I also never implied that coliforms were a "pathogen", but merely stated that there was a validated kill step which could eliminate pathogens. To make it a bit more clear and concise - I know that coliforms are not pathogens, but are an indicator for unsanitary conditions. Additionally, I've always been told the higher the coliform count, the higher the likelihood of there being fecal coliforms and E.coli present. The COA has results for E.coli, with a specification of <10cfu/g, HOWEVER, the results shown were ",10". I didn't state this in the OP, because it was likely a typo on behalf of the supplier (as the "comma" and "less than" symbols share the same key on the keyboard).
"PS - Regarding the red^^^, surely both supplier and receiver are aware that it is afaik impossible to make coliform measurements in less than 24 hrs (or sometimes more) so the criticism is likely logistically impractical"
I'm not sure what you meant by this, but I believe it again has something to do with how I worded my OP, regarding the supplier's statement. The supplier knew the coliforms were higher than specification allows, as it was written on their COA. What they basically told us was, "Well, it doesn't matter that coliforms were high, since you've already unloaded the truck. No backsies! Nah nah na boo boo!"
I didn't feel it was a good practice on their part, shipping ingredients outside of the allowed specification. But, as they said, we accepted the truck, so it's on us. We've requested that, going forward, COAs be sent via email prior to ingredients being shipped. This will hopefully prevent repeats of this same issue.
Thanks to everyone for their insights,
Thks yr posts.
It is unfortunate that the ingredient/Process is unknown.
I think QAGB has well-explained the point of my comment regarding 24hrs. This is a perennial problem with microbial specifications. Their evaluation typically takes "significant" time.
You are correct that I misinterpreted yr OP inasmuch as I thought it meant that you had tested the product after reception and found a (single?) .coliform result at 600cfu/g
I do agree it is surprising that the supplier would deliver a COA showing a result which indicates that the lot is out of specification. Human error? No screening?. Is there a history of previous lots having similar documentary errors or being genuinely found out of micro. specification at reception ?
Is the Supplier Approved (including cross-checking of ingredient microbial data ?
Regarding suggestions, I assume -
(1) incoming lot acceptance routinely based solely on receiving an acceptable COA.
(2) No micro testing routinely carried out at, or subsequent to, reception.
(3) "Senior Manager" is not within QA function.
(4) incoming lot acceptance not handled by QA (who are [or certainly should be] qualified individuals).
If above is correct, I suggest expanding (1) by implementing the opposite options to those currently stated in (2,3,4).
Regarding Regulatory Guidance, the Ingredient, Process, detailed micro. specifications are unknown. Need some info. to comment further.
PS - JFI, here are a mixture of evaluations of the usefulness of "Coliforms" as indicators of Sanitation/Post processing Contamination -
col1 - Evolving Role of Coliforms in US Milk Industry,2016.pdf 186.51KB
col2 - Coliforms in the Us Milk Industry, 1951.pdf 415.31KB
col3 - Public Health Inspector's Guide,Ontario,Canada,2019.pdf 1.6MB
col4 - Microbiological-specifications-Nestle,2014.pdf 911.91KB
PPS - Just for clarity, the thermal "kill step" is not designed to eliminate all the possible species which might exist within "coliforms" but IMEX it typically "deletes" most of them.
P3S - Regarding yr observation that E.coli MPN = 10cfu/g, this is a possible result from MPN Tables. Another human micro. error perhaps. Or just a typo.
P4S - The quantitative significance of a value of 600 cfu/g as compared to 500 cfu/g for Coliforms is simply negligible IMO. And especially if one datum only. And similarly <10 and 10 MPN/g. Nonetheless, in my product area (seafood), both values would be unusually high for a just cooked item. But one sample is insufficient to speculate.