28 replies to this topic

[foodsafetyAUS]

Hi all, this week, there was a nightmare in our factory. The micro lab informed us firstly that they found Listeria on end of life leafy bag then again emailed us they found a presumptive salmonella in the bag. 2 days after it was confirmed as a salmonella. Whole the factory went to almost crisis. The raw material came from one of our biggest grower so we had to stopped them to be used to the production. We had to send all raw materials for that grower for a rapid salmonella test to the lab then we sent 5 days of products made from that growers to the lab for the rapid salmonella test. It was around 100 samples. Then we did an environmental swabs of the area that product was in contact. QA team were in stress and tears as so much work overload and stress. Tech manger was questioned for all little errors instead of being supported during this crisis. Anyway all the result came back negative. We never had salmonella on any products or raw materials. I started to question whether lab made an error and put us in this drama!


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Edited by foodsafetyAUS, 28 March 2019 - 08:11 AM.

[Rener De Jesus]

If lab made, that was so cruel!

 

Did your lab collected samples for re-testing? 

[foodsafetyAUS]

No, as we discarded the sample. It was brutal.


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[EagleEye]

What was the result of that environmental samples then?
What happened to that first notified Listeria issue?

Could be an error from lab..

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[Scampi]

DO NOT presume the lab made an error...............listeria is known for being sneaky AND you're presumption would also have to be that the lab made not 1 but 2 errors

 

You only have a couple of options here:

 

Initiate a hold and release program 

 

Shut down plant for massive deep clean

 

How long have you used this lab...

What is the false positive rate of the testing methods they use

 

And change your process so the original samples do not get discarded

 

I direct you to the following research paper regarding Canada's largest listeria outbreak and the mistakes that were made with enviro testing results

 

https://www.cpha.ca/...-lirs-rpt_e.pdf

 

"In each instance, the plant staff took action to destroy the bug. They employed a ‘search and destroy’ approach - the recognized standard procedure - sanitizing all the surfaces where the bacteria could grow on production lines and throughout the building. Every time employees intervened, the follow-up test results were negative, at least for awhile. This led to the assumption that the problem had been solved, creating a false sense of security. What was missing was the big picture – recognizing the repeated pattern of presence of Listeria on the same production lines several weeks after the problem was presumed to have been fixed."

 

I have zero patience for the assumption that lab results are either an error or that 100 follow up swabs are sufficient to have the process under control. Unless the higher ups fully understand how listeria functions, you cannot assume anything............100 swabs (IMHO) are not enough to confirm complete removal of the bacteria. Salmonella is much easier to get rid of

 

How many more listeria swabs did you take? And from where, what pattern did you use

[Alfiebru]

When testing for Listeria it's useful to have an enumeration test, that way you can effectively gauge the food safety risk. A CFU/g of below 20 for Listeria monocytogenes is commonly deemed acceptable for RTE products. 

[Scampi]

http://www.inspectio...4/1528201904208

 

https://www.canada.c...foods-2011.html

 

From Australian food code

 

SCHEDULE Column 1 Column 2 Column 3 Column 4 Column 5 Column 6

Food Microorganism/test n c m M Ready-to-eat food in which the growth of Listeria monocytogenes will not occur Listeria monocytogenes 5 0 100 cfu/g

 

Ready-to-eat food in which the growth of Listeria monocytogenes can occur Listeria monocytogenes not detected in 25 g

[foodsafetyAUS]

What was the result of that environmental samples then?
What happened to that first notified Listeria issue?

Could be an error from lab..

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[foodsafetyAUS]

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[foodsafetyAUS]

What was the result of that environmental samples then?
What happened to that first notified Listeria issue?

Could be an error from lab..

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It was negative for salmonella. First lab called my manager and said it is Listeria then few hours after emailed us that the sample below is salmonella presumptive.
We really do not know. Few months ago they made an error too but it was not that massive or brutal. They reported us that one finished product has listeria presumptive then few days after the lab manager called my manager and said it was an error as their employee was in his last day of his work there and made lots of errors!


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[Scampi]

wow, what a mess!!!!!!!!!!

 

Find a new lab. this one clearly doesn't care at all the consequences of their ineptitude

 

Imagine for a minute that they MISSED listeria altogether.....................................................................................let that settle in

 

Any new certified lab is cheaper than 

A) a massive recall

B) lawsuit from the families of people who were ill/dead

[foodsafetyAUS]

DO NOT presume the lab made an error...............listeria is known for being sneaky AND you're presumption would also have to be that the lab made not 1 but 2 errors

You only have a couple of options here:

Initiate a hold and release program

Shut down plant for massive deep clean

How long have you used this lab...
What is the false positive rate of the testing methods they use

And change your process so the original samples do not get discarded

I direct you to the following research paper regarding Canada's largest listeria outbreak and the mistakes that were made with enviro testing results

https://www.cpha.ca/...-lirs-rpt_e.pdf

"In each instance, the plant staff took action to destroy the bug. They employed a ‘search and destroy’ approach - the recognized standard procedure - sanitizing all the surfaces where the bacteria could grow on production lines and throughout the building. Every time employees intervened, the follow-up test results were negative, at least for awhile. This led to the assumption that the problem had been solved, creating a false sense of security. What was missing was the big picture – recognizing the repeated pattern of presence of Listeria on the same production lines several weeks after the problem was presumed to have been fixed."

I have zero patience for the assumption that lab results are either an error or that 100 follow up swabs are sufficient to have the process under control. Unless the higher ups fully understand how listeria functions, you cannot assume anything............100 swabs (IMHO) are not enough to confirm complete removal of the bacteria. Salmonella is much easier to get rid of

How many more listeria swabs did you take? And from where, what pattern did you use

We are using this lab for years and it is a well-known multinational lab.
Thanks for sharing that pdf and also sharing your knowledge.
We took salmonella swabs on conveyors in high care, random crates, foaming tubes, incline conveyors, hoppers. Any area that leaves were in direct contact. We did after hygiene clean down.


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[foodsafetyAUS]

wow, what a mess!!!!!!!!!!

Find a new lab. this one clearly doesn't care at all the consequences of their ineptitude

Imagine for a minute that they MISSED listeria altogether.....................................................................................let that settle in

Any new certified lab is cheaper than
A) a massive recall
B) lawsuit from the families of people who were ill/dead

True. I think we need to be in contract with two labs so we can validate them. However it is company head office decision and we cannot make this call.


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[Scampi]

but you can prepare a cost benefit analysis to help them make up their minds   wink wink

[zanorias]

I'd seriously assess using another lab. As Scampi pointed out - consider they missed listeria, that is what worries me. I've just changed labs after the previous one kept "losing" samples and delaying tests so long that the test becomes invalid 

[QA-Tech]

Totally agree with the above, you need a reliable lab! Great tip Scampi about cost analysis; nothing like showing them what a potential outbreak or even a recall can do to a company!

 

It might also be helpful to your team to create a documented explicit procedure in the event of a positive result. Could help reduce the chaos with step by step protocols in place and less chance of missing critical steps/sampling opportunities. 

[Charles.C]

My sympathies, this kind of problem is what QA departments always dread.

 

A few technical thoughts -

 

There is presumably no "kill" step in the RTE Process.

 

Listeria is ubiquitous in the environment. Detection in raw material  is  likely not "if" but "when".

 

Salmonella is not ubiquitous but contamination at source needs to be ruled out.

 

Sampling density is particularly relevant for, hopefully, low levels of "contamination". Unfortunately logistics/cost may rapidly come into play.

 

Re-sampling at low levels is statistically often a probable negative except for gross contamination.

 

Confirmed Salmonella typically involves serology and (ideally) typing. It can take time but is usually definitive.

 

Detection may indicate a need for a "chemical"  change in the bacterial reduction stage of  process.

[Jpainter]

Are you washing product in post harvest wash water, or is it coming in pre-washed? If you are washing the produce on site, you  may want to look at changing sanitizer chemicals in your wash water. For example, if you are currently using sodium hypochlorite, switch to a peracetic acid. This should help avoid any bacterial resistance to certain sanitizers. This is the same concept of changing your sanitizer for the sanitation procedure every so often. As far as a possible lab error goes, I have always collected duplicate samples that get thrown away as soon as results come in from the original. However, if the original sample comes back positive, the duplicate is sent to a separate lab for analysis. You would still have to follow all corrective actions because a duplicate sample negative result does not replace the original result. This duplicate sample is more for internal use to confirm that this is an isolated issue and not widespread. Hopefully this had some useful or thought provoking information for you. 

 

Best of luck on getting management support, 

 

Jpainter

[foodsafetyAUS]

Are you washing product in post harvest wash water, or is it coming in pre-washed? If you are washing the produce on site, you may want to look at changing sanitizer chemicals in your wash water. For example, if you are currently using sodium hypochlorite, switch to a peracetic acid. This should help avoid any bacterial resistance to certain sanitizers. This is the same concept of changing your sanitizer for the sanitation procedure every so often. As far as a possible lab error goes, I have always collected duplicate samples that get thrown away as soon as results come in from the original. However, if the original sample comes back positive, the duplicate is sent to a separate lab for analysis. You would still have to follow all corrective actions because a duplicate sample negative result does not replace the original result. This duplicate sample is more for internal use to confirm that this is an isolated issue and not widespread. Hopefully this had some useful or thought provoking information for you.

Best of luck on getting management support,

Jpainter

Thanks for your information. I found it very useful.


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[Charles.C]

Thanks for your information. I found it very useful.


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Sorry to be a little negative but I think a few more caveats may be in order -

 

IMEX duplicate" samples are often problematic in microbiology since to be of any value they necessitate a uniform distribution in the sampled lot. Unfortunately pathogens at low levels in many, diverse, sourced raw materials,of which I anticipate fresh produce is one, frequently do not oblige in this way. See "sampling" my previous post.

 

Regarding sanitisers there are several well-known commercial versions of peracetic acid which yr company/supplier must surely be aware of already ? eg -

 

https://www.foodsafe...-food-industry/

 Tsunami (1).pdf   2.41MB   1 downloads

 Tsunami (2).pdf   1.39MB   1 downloads

 

Frankly I would have thought it is critical to audit/validate yr supplier's production procedures. You don't seem to have done that yet ?  Does the supplier have GAP certification  ?

 

PS - out of curiosity what sanitiser do you currently use ?

[foodsafetyAUS]

Sorry to be a little negative but I think a few more caveats may be in order -

IMEX duplicate" samples are often problematic in microbiology since to be of any value they necessitate a uniform distribution in the sampled lot. Unfortunately pathogens at low levels in many, diverse, sourced raw materials,of which I anticipate fresh produce is one, frequently do not oblige in this way. See "sampling" my previous post.

Regarding sanitisers there are several well-known commercial versions of peracetic acid which yr company/supplier must surely be aware of already ? eg -

https://www.foodsafe...-food-industry/
Tsunami (1).pdf
Tsunami (2).pdf

Frankly I would have thought it is critical to audit/validate yr supplier's production procedures. You don't seem to have done that yet ? Does the supplier have GAP certification ?

PS - out of curiosity what sanitiser do you currently use ?

Hi Charles, our growers have GAP certificate and we monitor them very closely. The chemical that we use is paracetic acid. Still I think the error came from the lab.


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[Charles.C]

Hi Charles, our growers have GAP certificate and we monitor them very closely. The chemical that we use is paracetic acid. Still I think the error came from the lab.


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Hi FSA,

 

If ^^ I suggest you investigate what Procedure was used for Salmonella and the results thereof.

 

Not familiar with Australian Standard but, for example, full implementation (biochemical/serological) of BAM leaves IMO little chance for analytical error. Even less if species typing is eventually carried out.

 

Or perhaps you suspect (somewhere) contaminated samples ? Conspiracy Theory ?

 

Not familiar with Australian situation but sadly Fresh Produce seems locked in as "High Risk"  in US/Europe -

 

https://www.thepacke...during-shutdown

 

 Review Outbreaks in US-EU due Fresh Produce,2015.pdf   170.33KB   2 downloads

 

[foodsafetyAUS]

Hi all dear participants, today lab confirmed that there was a cross contamination in the lab. So basically it was a lab error. “It has been advised that cross contamination at the lab was identified as the root cause.”

I suddenly told our production manager that we should sue them and he said it is a big thing to say! But why not. We stoped using our biggest grower for whole the week! Many more drama happened as I mentioned previously. Anyway, at least they admit it.
It was hectic but the outcome was good. Our leaves does not have salmonella. :)



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[Scampi]

I would!  They need to understand in this day and age when companies need to act quickly that they need to follow proper protocols within their labs. False positives are one thing, ineptitude is another.

So sorry for all your trouble, but glad everything will resume as normal!

[zanorias]

Glad to hear it wasn't an error on your part and the product is ok. I bet 'relief' is an understatement for your team.

 

I think the lab should be liable for loss, at least of raw material not to mention the time, stress, equipment, potential supplier relation issues, loss of production etc etc it must have caused you guys. Just as you could be financially liable if there was actually an outbreak and it reached the customer. Ineptitude is a key word, and finances of the current situation aside, the prospect of a repeat of this in future or even missing a positive result is concerning. I presume you will be switching labs?