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Supplier shipped ingredient outside allowed Coliform limit


Best Answer , 06 December 2019 - 06:58 PM

BostonCream brings up a valid point. If you have a valid kill-step it shouldn't be a huge concern. Looks like your Senior QA Manager approved it because you have a kill-step and shouldn't cause issues.

 

On the other hand, if you have a procedure, and that procedure says you are not to receive products out-of-spec, then you don't receive them. As you stated, this one fell through the cracks, and it was received. Then it was quarantined (which at least at this point it was caught). Regardless, the supplier had a limit on their COAs, and this product exceeded it. If that is the case, then they had no business sending it to you without notification and receipt of approval from you first. 

 

As a company, anything that we tested out-of-spec was placed on hold. The only time that out-of-spec product was shipped was if we discussed with the customer and got their sign-off on the release first. 


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Chrispy Chips

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Posted 06 December 2019 - 04:39 PM

Hey all,

 

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.

 

Thanks,

Chrispy



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Posted 06 December 2019 - 05:07 PM

According to your own documentation - who is the person/position that places product on hold and who/position is the one that can release it from hold?


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Posted 06 December 2019 - 05:10 PM

Its best to have your COAs sent prior to the truck even arriving. So you can tell your supplier "hey sorry but we can't accept this product, send us another lot". So not a ccp in your plan... how will you validate and verify the kill step indeed kills the coliforms? Kill steps need validations to ensure they are reducing/minimizing and killing the pathogens before release.

 

If it were me, just reject the ingredient and talk to your supplier. Or tell them next time to send the COA beforehand so you know whether to accept or reject before truck is unloaded. 


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Chrispy Chips

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Posted 06 December 2019 - 05:29 PM

According to your own documentation - who is the person/position that places product on hold and who/position is the one that can release it from hold?

Any qualified employee can initiate a hold, investigation is performed by QA, and final disposition is the responsibility of management.

 

Our corporate QA manager is the one that released it for use.



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Posted 06 December 2019 - 05:36 PM

Its best to have your COAs sent prior to the truck even arriving. So you can tell your supplier "hey sorry but we can't accept this product, send us another lot". So not a ccp in your plan... how will you validate and verify the kill step indeed kills the coliforms? Kill steps need validations to ensure they are reducing/minimizing and killing the pathogens before release.

 

If it were me, just reject the ingredient and talk to your supplier. Or tell them next time to send the COA beforehand so you know whether to accept or reject before truck is unloaded. 

 

Some suppliers send COAs prior to shipment, but we've got many where the micro results are simply listed as "TBD", and we don't get the actual results until the truck arrives. It's going to be addressed going forward.

 

We have two separate steps in our process that will kill any pathogenic contaminants (both have been validated, but are just not listed as CCPs), so essentially the risk of it being in the finished product are practically impossible, especially if all facility PRPs are being followed. My main concern is - why even require micro results if we're just going to receive the truck anyway? It's honestly just a frustration on my part at this point, since senior management has made a decision.



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Posted 06 December 2019 - 05:44 PM

Hi Chips,

 

just curious, If you have validated kill step, why do you set the coliform limit in raw ingredient?



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Posted 06 December 2019 - 06:01 PM

Hi Chips,

 

just curious, If you have validated kill step, why do you set the coliform limit in raw ingredient?

The kill step validation was performed by site Quality Manager before our facility was GFSI certified. The micro counts and other specifications are agreed upon between the supplier and our corporate R&D dept. It's not something I understand, either. Many of the activities that take place at this company are very "don't let the left hand know what the right hand is doing". Makes no sense...



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Posted 06 December 2019 - 06:58 PM   Best Answer

BostonCream brings up a valid point. If you have a valid kill-step it shouldn't be a huge concern. Looks like your Senior QA Manager approved it because you have a kill-step and shouldn't cause issues.

 

On the other hand, if you have a procedure, and that procedure says you are not to receive products out-of-spec, then you don't receive them. As you stated, this one fell through the cracks, and it was received. Then it was quarantined (which at least at this point it was caught). Regardless, the supplier had a limit on their COAs, and this product exceeded it. If that is the case, then they had no business sending it to you without notification and receipt of approval from you first. 

 

As a company, anything that we tested out-of-spec was placed on hold. The only time that out-of-spec product was shipped was if we discussed with the customer and got their sign-off on the release first. 



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Charles.C

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Posted 07 December 2019 - 02:23 PM

Hey all,

 

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.

 

Thanks,

Chrispy

 

Few comments.

 

Ingredient/Product/Process is unknown.

 

"Coliform" is not classified as a pathogen so the OP is seemingly based on a misinterpretation from a safety POV.

 

Additionally, IMHO, unless there is a good reason to the contrary (eg [perhaps] Regulatory, heat treated, abnormal/astronomic number), setting an accept/reject criterion of 100cfu/g for Coliform is often ridiculous/unjustifiable - particularly if done on one sample (???)/using an arbitrary procedure.

 

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


Edited by Charles.C, 09 December 2019 - 05:41 AM.
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Kind Regards,

 

Charles.C


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Posted 11 December 2019 - 01:41 PM

Few comments.

 

Ingredient/Product/Process is unknown.

 

"Coliform" is not classified as a pathogen so the OP is seemingly based on a misinterpretation from a safety POV.

 

Additionally, IMHO, unless there is a good reason to the contrary (eg [perhaps] Regulatory, heat treated, abnormal/astronomic number), setting an accept/reject criterion of 100cfu/g for Coliform is often ridiculous/unjustifiable - particularly if done on one sample (???)/using an arbitrary procedure.

 

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

 

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,

Chrispy



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Posted 11 December 2019 - 01:58 PM

 

 

"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,

Chrispy

 

 

Hi Chrispy,

 

Charles means the supplier should know that even if you received the product and tested it for coliforms before you technically approved it, it would take longer than 24 hours for approval (which isn't logistically feasible in most cases). Therefore, it isn't practical to expect you would possibly test received product on-site before approval. Therefore you'd need to have the COA on hand before receipt, or be sure to check all of your spec parameters on the COA you receive with the shipment. 

 

Either way, the supplier playing "no backsies" on product they knew was out of spec is unacceptable in my book. I suspect you'll be watching this supplier like a hawk going forward.


Edited by QAGB, 11 December 2019 - 01:58 PM.


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Posted 12 December 2019 - 01:47 AM

Hey all,

 

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.

 

Thanks,

Chrispy

 

 

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,

Chrispy

 

Hi Chrispy,

 

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 - 

 

Attached File  col1 - Evolving Role of Coliforms in US Milk Industry,2016.pdf   186.51KB   4 downloads

Attached File  col2 - Coliforms in the Us Milk Industry, 1951.pdf   415.31KB   6 downloads

Attached File  col3 - Public Health Inspector's Guide,Ontario,Canada,2019.pdf   1.6MB   6 downloads

Attached File  col4 - Microbiological-specifications-Nestle,2014.pdf   911.91KB   6 downloads

.

 

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. :smile:

 

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.


Kind Regards,

 

Charles.C


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