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High E.coli count detected by customer


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carine

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Posted 09 May 2019 - 07:14 AM

Hi all, 

 

our customer was detected high E.coli count in our product. What is the corrective action should be carried out in this situation? Corrective action write-up will be much more appreciated.  Thx in advance. 



FSQA

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Posted 09 May 2019 - 12:55 PM

Hi all, 

 

our customer was detected high E.coli count in our product. What is the corrective action should be carried out in this situation? Corrective action write-up will be much more appreciated.  Thx in advance. 

Are they sharing their in-house lab results or third party lab results? What is the product in query? You mentioned High Ecoli results, what are the specs/max limits for this product?

 

Initial Steps:

Hold any product if you have in-house from this batch.

If you have the product or retention samples, send samples to an independent third party lab for analysis( even if it was tested right after production). IMO it is always beneficial to send multiple samples.

Advise your customer, to hold the product and while micro results are pending,  gather data about this lot at your end (which other customers this was sent to, raw materials used, etc.)



Charles.C

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Posted 09 May 2019 - 06:24 PM

Hi all, 

 

our customer was detected high E.coli count in our product. What is the corrective action should be carried out in this situation? Corrective action write-up will be much more appreciated.  Thx in advance. 

 

>>>>

 

https://www.ifsqn.co...lt/#entry141550


Kind Regards,

 

Charles.C


carine

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Posted 10 May 2019 - 06:43 AM

Are they sharing their in-house lab results or third party lab results? What is the product in query? You mentioned High Ecoli results, what are the specs/max limits for this product?

 

Initial Steps:

Hold any product if you have in-house from this batch.

If you have the product or retention samples, send samples to an independent third party lab for analysis( even if it was tested right after production). IMO it is always beneficial to send multiple samples.

Advise your customer, to hold the product and while micro results are pending,  gather data about this lot at your end (which other customers this was sent to, raw materials used, etc.)

hi, this is their 3 party lab results. the standard for E.coli is Nil. There is no sample retention   as we only been informed after 2 weeks of delivery. 

 

We did sent few samples for lab test , the results shown negative. I was wondering how did u all handling and respond to customer in such situation.  



Simon

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Posted 10 May 2019 - 07:29 AM

Carine, please do not start multiple topics on the same subject. 

If you have further questions or clarifications, add your replies here.

 

Thanks,
Simon


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Dapulu

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Posted 10 May 2019 - 08:43 AM

Try to locate more samples that you may have in market and segment the times fo the batch that you are suspicious of having the high E. coli count. May be a specific time frame that has the issue, could also be more sporadic. Review sanitation records. Have you and your team analized where could the possible contamination be from? As in the root cause?

 

You need to gather more info and although it may seem rude or offensive to the customer if it gets known, do make sure the 3rd lab is using the adequate procedures and are certified for it. If it is possible to get a part of the sample the customer sent, that would also be great although it may be tampered.

 

Could be a bad GMP case, could be some random fella trying to drain money through a lawsuit, could be a major problem for your product. Keep on getting that info and ruling out possibilities :)

 

Hope this helps a bit.



FSQA

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Posted 10 May 2019 - 01:17 PM

Carine,

 

IMO: you should share your third party lab results and (if any) post production micro results of this with the customer. Keep them updated with the steps of your root cause analysis. If you dont have samples, request your customer to send 3-5 samples of the batch in query, to a third party accredited micro lab to further analysis (preferably tot he lab that you are using, if they agree) to rule out any false positives.

 

Few considerations:

  • The results they shared are just from analysis of your product (raw material) or they are quoting the results of "Their Finished Product". If latter is the case, how did they rule out other ingredients as the culprit?
  • The product was with them for 2 weeks, so is there a possibility if that would have been contaminated at thier location?
  • Still pending the type of product and if you can share how the product was treated for micro (steam/irradiation/other)?
  • During performing all the above steps, please continue to run a root cause analysis as mentioned in Post # 6 and in the link shared by Charles in post # 3 above, to identify a possible failure in your system.





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