Out of Spec CoAs

Has anyone dealt with a situation where finished product is sent to lab and the results for non pathogen results (APC, Coliforms, Yeast, etc.) are higher than the specifications and senior management wants to send other finished product from different lot codes to the lab until acceptable results are received because CoAs have to be sent to a customer? 

I am not sure how to proceed with something like this as it does not align with my values and ethics regardless of wether it is APC or listeria. 

Thanks

Hi QAKat,

:w00t:

Totally illegal and unethical.

No, it hasn't happened to me because everyone that has worked with me knows that I would refuse, my sympathies are with you for having to work with these morons.

I presume that you have had the lot resampled and retested? there can be issues with sample abuse or errors in testing.

Kind regards,

Tony

Has anyone dealt with a situation where finished product is sent to lab and the results for non pathogen results (APC, Coliforms, Yeast, etc.) are higher than the specifications and senior management wants to send other finished product from different lot codes to the lab until acceptable results are received because CoAs have to be sent to a customer? 

 

I am not sure how to proceed with something like this as it does not align with my values and ethics regardless of wether it is APC or listeria. 

 

Thanks

Hi QAKat,

IMO it may depend on the actual OOS/COA numbers. Micro data can be notoriously inaccurate (and sometimes same for samples also).

Senior Management could perhaps be justified in some resampling albeit not for the unfortunate reason given.

I agree with Charles: we've experienced this situation many times, when micro showed count - and after sending to the lab other set of samples (of the same batch), the testing showed clean. That's because of the lab error - though, your lab might not admit it.

You legally (and morally) cannot represent a CoA from a different batch (please refer your management to the Peanut Corporation of America disaster)

https://www.npr.org/...onella-outbreak

https://www.theguard...onella-outbreak

Re-test the batch to rule out lab error

and if management won't play-------call the FDA and submit your resignation you're obviously working for scumbags

This is a prime example of why I have NO FAITH in GFSI programs--------these bad actors can only be caught via stringent government regulation (the fact that management would even suggest this is deplorable)

I changed our setup so I don't even retest anymore.   Honestly imho lab screw ups are rare, super rare.   If there's an issue it's probably with you, either poor cleaning or sample collection.   Also imho, you can't test away a bad test with one retest.   

I switched to a positive hold system, so I won't release my finished product until I get results back.   If results are bad, I toss the batch, and that way avoid any recalls due to bad test results.

But yeah, agree, you're wading in dangerous waters here....

Your OP is a little unclear, results from different lot codes are not interchangeable. It almost sounds like this -isn't- a case of retesting. In this case you should be holding non-conforming lots for investigation while releasing the lots that do conform to your specification. This of course depends on your manufacturing process, which we don't know very much about. Typically different lot codes represent different production batches. And if you're using results from one lot to represent another lot, that's illegal.

In the case of retesting the same lot until you get results you like...that's not acceptable either. If you have reason to believe your lab is mishandling your samples or is not properly trained to do the testing, you shouldn't be resending them to the same lab until you get results you like. Instead you should document the reasons for your suspicion of this lab and look to qualify new labs for your 3rd party testing. And even then it's still very dubious territory. Personally I wouldn't feel comfortable pursuing that route and would instead hold the material for some kind of re-processsing (heat treatment of appropriate) to address the microbial concerns.

The OP's described solution to achieving an acceptable data set for a claimed, LOT containing several individual  Codes is obviously, politely, "misrepresentation". Less politely - fraudulent..

Assuming viable micro. data on individual Codes which constitute the final LOT is available, this data could be approximately, statistically, combined (with a few assumptions).

Or the final, combined, LOT could be appropriately resampled as an isolated LOT if accessible. (This is what FDA, unavoidably, do for incoming LOTs although IMEX their attention is mostly focussed on zero-tolerant pathogens).

Just as an illustration, textbook typical  statistical, accuracies for APC data on a random LOT are often +/- 50 % or worse.

The nmMc approach attempts to allow for fluctuations such as above for a given Lot so as to achieve a GO/NO GO decision.

.

IMO, more information as to the methodologies used by OP, specific COAs and actual results/deviations are needed to say much more..
 

Hello all.

Customer for this one product only requests 1 CoA per month so what I mean is that SM wants to send out a lot to lab and if APC for example comes back higher than customer specs for that day/lot then they want to hide that CoA, send the next days lot to lab and see if all results are ok to send that CoA to the customer. IDK if that makes sense but I am sure that is deff totally illegal as well because they AND ME will know that there is a lot with bad results! I told them I couldn't do that and that if they wanted to proceed then they would sign all documents pertaining to it. I just got yelled at and told that what would I want them to do!? "Dispose of all that product!!!" 

Uhhh YEAH!!! 

The procedure in place is hold all product until results are received but at the end of the day they don't listen and want to do what they want.

Ugh. I feel like crap and defeated and I know I have to move on. 

Thank you all for the replies.

Hi QAKat,

That doesn't sound as bad as it appeared from your first post, although clearly it is still wrong.

As per Charles' post APC results can vary quite significantly and labs can make errors* so it be interesting to know the spec. and the variation that you are getting in results. Maybe the customer's spec. is too tight?

* I once had a major biscuit manufacturer (in the top ten in the world) regularly rejecting 20 Tonne tankers of Skimmed Milk Powder for high APC. Our results were consistently in spec. In the end we had a big meeting at their head office and they confessed to using the wrong dilution!

Also, if there is some action being taken to investigate and remedy the high counts? or is the automatic action to ignore and test a different batch?

Kind regards,

Tony

... senior management wants to send other finished product from different lot codes to the lab until acceptable results are received ...

 

 

I'm curious what is/was done with the lot that got the high result.  Was it resampled, held, withdrawn etc.?

The customer might not be picky about which lot their CoA reflects, but if they received and used the one with a high count that's a different story ...