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amberlyda

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Posted 05 April 2021 - 08:34 PM

Hello, we introduced a new line to our factory that processes ready to eat edible cookie dough. We send all of our dough samples out to be tested for APC, Colifom and listeria. Since introducing the new processing line our APC counts have come out higher and out of an abundance of caution we have thrown away several pallets.. I have done in-house surface testing for APC and all of our equipment has tested under 10cfu/g.  All of our daily ATP counts are coming in under spec when I send the dough out some of my APC results are at 38,000cfu/g, but everything else is negative.  When I ask for a retest sometimes the results on the same samples come in at <10 cfu/g. I have even tested the entire line after the equipment has sat over the weekend and its still testing clean. I have kept everything in place from the previous QA manager until I run into problems like this and have to reassess our practices. What is going on? Am I testing for the correct things? Should I be using APC to determine safety of the product? If anyone can give me guidance I would appreciate it.  I have a biology background, but I am driving this ship by myself in the quality department and need industry advice. Thank you so much

 



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Posted 06 April 2021 - 01:44 AM

Hello,

 

We introduced a new line to our factory that processes ready to eat edible cookie dough.  We send all of our dough samples out to be tested for APC, Colifom and listeria.  Since introducing the new processing line our APC counts have come out higher and out of an abundance of caution we have thrown away several pallets..

I assume the dough is thermally pasteurised?. How, Oven? What temperature/time ? Chilled ? Frozen ?

I assume you meant higher [ than spec.]

I have done in-house surface testing for APC and all of our equipment has tested under 10cfu/g.  All of our daily ATP counts are coming in under spec

I assume you meant 10cfu/cm2

when i send the dough out some of my APC results are at 38,000cfu/g, but everything else is negative.
Not impossible. i would have expected coliform low/not detected and Listeria not detected.
  When i ask for a retest sometimes the results on the same samples come in at <10 cfu/g

The latter figure sounds highly improbable if only pasteurised ?, ie must be laboratory error ?.

I have even tested the entire line after the equipment has sat over the weekend and its still testing clean.

Presumably after cleaning/sanitising.

 

I have kept everything in place from the previous QA manager until i run into problems like this and have to reassess our practices.

 

What is going on?

Am i testing for the correct things? 

What are results for Coliform/Listeria?

Should i be using APC to determine safety of the product?

APC is unrelated to safety.

 

 

If anyone can give me guidance i would appreciate it.  I have a biology background, but i am driving this ship by myself in the quality department and need industry advice.

What are product's micro. specifications.?

thank you so much

 

Hi amberlyda,

 

Please clarify process method and data queries above. Need to compare results within individual data sets (ie APC/Coliform/Listeria) for same batch and between different batches. Hopefully you do not take only one sample per batch.

 

I would have thought to also test for generic E.coli, Salmonella and possibly L.monocytogenes but maybe dependent on results for current data sets.

 

Are the non-micro, quality results OK ?


Kind Regards,

 

Charles.C


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Posted 06 April 2021 - 03:25 PM

Is this product cooked, processed in any way? Keep in mind the more you handle it or leave it exposed to the environment, the higher the counts will be.

Why are you testing for listeria? Are you testing the finished product? If you are, keep in mind you have to establish a hold and release program.

Also: what are your limits for the APCs and how did you determine these limits? APCs could mean a whole lot, or not much at all!

So many questions!

 


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Posted 06 April 2021 - 04:31 PM

Hi amberlyda,

 

Please clarify process method and data queries above. Need to compare results within individual data sets (ie APC/Coliform/Listeria) for same batch and between different batches. Hopefully you do not take only one sample per batch.

 

I would have thought to also test for generic E.coli, Salmonella and possibly L.monocytogenes but maybe dependent on results for current data sets.

 

Are the non-micro, quality results OK ?

 

 

This i s raw ready to eat cookie dough.  After the batter is made it goes though a die cutter and passes through a nitrogen tunnel at -170deg.  We do not have a kill step for this product, it just goes through the nitrogen tunnel and then is packed and held in the freezer.  I collect one finished sample from every bowl of dough at the end of the line.  Each sample is comprised of 12 pieces.  We typically make a composite sample of 3-4 bowls and send that to the lab for them to portion out and do a micro sample on.  Basically we comprise the samples by the pallet so they are easy to retain if additional testing needs to be done.

 

During our post op checks and before the cleaning staff leaves we perform ATP testing on all of the machines.  We use the hygiena ATP system and have a fail limit of 30 RLU.  If a system tests anywhere close to this amount or above the machine has to be recleaned and sanitized again.

 

I have done in  house testing for APC.  This most recent testing was done after the factory was closed for 48 hours over the weekend and I still got test results that tested under spec on the food contact surfaces.  

 

Im not sure if it is CFU/g (2).  my test results only state 10,000cfu/g as the fail limit for outside testing

 

When we have a sample retested we often get vastly different results off of the same sample.  It is very common that we will have a high APC and when retested it drops.

We have had coliform results in the past above spec but it is very rare 

 

Our critical limits for micro testing are listed in our food safety plan " CCP#2, Listeria results are negative, APC results less than 9,999 cfu/g, coliform counts less than 10 cfu/g"

 

The ingredients we have in the product are: heat treated flour, sugar, water, baking soda, milk powder, salt, sprinkles, cocoa, chocolate, margarine

 

 

I need these results to provide COAs for some of our customers.  Are the parameters set correctly?  Should i be asking the lab for anything?

 

In reguards to APC how should i be treating the product if it tests high?  Should i be disposing of it?  If APC is high and no coliform or listeria is detected how should i treat the product?

 

Any and all advice is needed.



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Posted 06 April 2021 - 04:49 PM

amberlyda,

That fact this product does not have a killstep explains why the counts are so high. It's being processed at your place and being exposed to the environment, which is gonna shoot up those counts. It'd be wary of testing for listeria mono. Listeria spp is more appropriate & no food contact areas, & no product.

Do you get COAs for this flour?

I wouldn't rely on ATP, as it doesnt mean much.

I know I'm jumping all over the place with these questions, micro can be complicated.


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amberlyda

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Posted 06 April 2021 - 05:01 PM

Is this product cooked, processed in any way? Keep in mind the more you handle it or leave it exposed to the environment, the higher the counts will be.

Why are you testing for listeria? Are you testing the finished product? If you are, keep in mind you have to establish a hold and release program.

Also: what are your limits for the APCs and how did you determine these limits? APCs could mean a whole lot, or not much at all!

So many questions!

 

 

 

 

The product is mixed, then put into the system to be cut into the right sizes.  It then immediately goes into the nitrogen tunnel at -170 deg.  It then goes on a conveyor to the scale to be portioned and dropped into the packaging.  The product has very little human interaction which is why im so surprised that we have been having so many problems since we put this system into place.There is no kill step with this product.  It is raw cookie dough that is ready to eat.  We do have a hold and release program in place.



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Posted 06 April 2021 - 05:28 PM

amberlyda,

That fact this product does not have a killstep explains why the counts are so high. It's being processed at your place and being exposed to the environment, which is gonna shoot up those counts. It'd be wary of testing for listeria mono. Listeria spp is more appropriate & no food contact areas, & no product.

Do you get COAs for this flour?

I wouldn't rely on ATP, as it doesnt mean much.

I know I'm jumping all over the place with these questions, micro can be complicated.

 

We test for general listeria non specified on the actual product and at the facility (we dont test zone 1).  We are an SQF facility and have COAs for all food. food contact products in the building.  We just use ATP for verification on cleaning along with visual inspections.

 

So for a raw ready to eat cookie dough, what should i be testing for?  I need to provide COAs for some of our clients.

 

The products contains some or all of the following ingredients: heat treated flour, sugar, , margarine, baking soda, milk powder, salt, cocoa, chocolate, sprinkles



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Posted 06 April 2021 - 06:02 PM

amberlyda,

I cannot tell you what you should be testing for. It's a combination of your customer, industry, scientific, & historical data.

This you must reach a determination based on risk. However, I'd be hesitant to test finished product for Listeria of any kind. That's asking for trouble.

You're processing the product and not having a killstep towards the end, so your APC counts will be elevated. The fact there's no human interaction is irrelevant. The product is being processed so the more steps, & processing it goes though, the more elevated the APC counts can become.

Also consider, relatively elevated APC does in not indicative of lack of food safety.

What I don't understand is where the 10,000 APC limit came from, what is the reasoning behind deciding it to the 10,000 APC, specially if the test results are all over the place and not being consistent?


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amberlyda

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Posted 06 April 2021 - 06:16 PM

amberlyda,

I cannot tell you what you should be testing for. It's a combination of your customer, industry, scientific, & historical data.

This you must reach a determination based on risk. However, I'd be hesitant to test finished product for Listeria of any kind. That's asking for trouble.

You're processing the product and not having a killstep towards the end, so your APC counts will be elevated. The fact there's no human interaction is irrelevant. The product is being processed so the more steps, & processing it goes though, the more elevated the APC counts can become.

Also consider, relatively elevated APC does in not indicative of lack of food safety.

What I don't understand is where the 10,000 APC limit came from, what is the reasoning behind deciding it to the 10,000 APC, specially if the test results are all over the place and not being consistent?

 

 

Those were the standards that were in place when I took this position.  We were keeping the APC counts under 10,000cfu/g until we started this new line.  You are correct that even though we have less human interaction, we have a longer processing chain.  I appreciate all of your help.



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Posted 06 April 2021 - 07:52 PM

Also, something that has not been mentioned yet----the exclusion of egg does not mean your product is ready to eat.....flour is a very real contributing factor

https://www.cdc.gov/...5-19/index.html

 

so unless you're adding a kill step somewhere in the process, you're not actually making RTE product at all


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Posted 06 April 2021 - 07:58 PM

Scampi,

It is absolutely possible to have an RTE product without a kill step. An RTE product is defined as a product that does not receive a process that will significantly reduce the bacterial load prior to packaging. Fresh-cut produce is an excellent example.


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Posted 06 April 2021 - 08:02 PM

Also, something that has not been mentioned yet----the exclusion of egg does not mean your product is ready to eat.....flour is a very real contributing factor

https://www.cdc.gov/...5-19/index.html

 

so unless you're adding a kill step somewhere in the process, you're not actually making RTE product at all

 

We use heat treated flour and it comes with COAs



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Posted 06 April 2021 - 10:01 PM

I don't have a lot of bakery experience, but I'll chime in and maybe something will help or stick.

 

1.  Lack of heat treatment is concerning.  You have a high risk product, even though you freeze it.  Mind you, freezing something does not kill all bacteria and/or pathogens.  Listeria, for example, can survive freezing conditions only to grow out when thawed which can occur at refrigeration.  So, that's quite a risk.

 

2.  Good you have heat treated flour and hopefully, their COA shows Coliform limits that are low, and E.Coli as negative.  Perhaps salmonella as negative too?

 

3.  You can almost completely disregard APC counts from a safety standpoint as they are generally not related.  But, you need to vet out the pathogens of concern for the product which in my mind is E.Coli, Salmonella, and Listeria.

 

4.  It seems you have proven your equipment sanitation.  APC counts can elevate over time in production as you run longer the bacteria tends to build up and grow.  You may have to shorten run time to keep the APC counts in line if you customers require a limit that's below what you are able to achieve.

 

5.  I'm not 100% clear on your process after freezing.  You freeze it and then store refrigerated or frozen?  How do you resample a batch if you see the micro counts are out of spec?  If its stored frozen on site you can actually see a decrease in APC and Coliform over time as freezing will kill some of it.  Not sure if that is playing a role in the different results you see.

 

6.  I know it's a challenge, but if you can convince management to put in a kill step process that would be ideal.  You are almost playing Russian Roulette.  I wouldn't solely rely on supplier COA's either.  I would setup a routine ingredient testing program to verify the COA's.  Flour, cocoa, and milk powder can all be problematic for you, the chocolate as well (dependent on the form of chocolate).  You didn't say you added water, but I'm assuming you do?  Water can activate dormant spores depending on temperature you blend.



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Posted 07 April 2021 - 03:42 AM

Hi amberlyda,

 

Personally, despite I can see some advertising/FDA usages, I would avoid calling this product raw RTE dough since afaik "raw dough " is usually understood as involving cooking. Maybe USA is "special" though. :smile:

 

4 initial comments -

 

(1) As stated, yr internal APC surface data appears meaningless from a "unit" POV. Maybe there is some data misunderstanding somewhere.

 

(2) Since you apparently have in-house micro. lab capability for APC, why not do some finished product testing yourself ?

 

(3) If yr samples sent to lab are genuinely representative of a stable process, yr variable results on same sample would suggest to find another lab. A possible check is to deliberately prepare one reliable, well-mixed process sample and divide into 2 portions which are both submitted randomly within a larger batch. Additionally, if you have any item which you are confident possesses an appropriately low APC value, can include as a dummy reference sample.

(I assume you are aware that APC counts are notorious for exhibiting considerable scatter)

 

(4) Offhand,  If there are a variety of mixed inputs, I suspect yr APC limit is quite demanding for the process such as presently described. What kind of "satisfactory" end product results were mostly achieved previously, eg <5000cfu/gram, in the range 5000-10,000cfu/gram, or ??

(JFI, IMEX of RTE seafood, a limit of 100,000 cfu/g (or more) is quite common although figures down to 10000/g can also be found)

 

As I understand, yr process, basically, is to mix various ingredients together then freeze and store.

 

The usual approach in case of micro problems at end of process is to start from the beginning eg -

 

(a) actual test data for micro, eg APC,  for input ingredients (Not just COA values).

 

If input results are all consistently, acceptably, low, then typically implies either (i) Process contamination due XYZ or (ii) micro growth in Process due time/temperature (delays?) problems. This requires a close look at the Process staging/temperature control.

 

Hopefully when yr process gave satisfactory end data, you have some records for (a) to enable a comparison/evaluation. Either way you still need some current, reliable, input data.

 

I did a quick search for micro.specs, eg APC, for RTE "edible" dough but could not find a single one. I anticipate there are no official, eg FDA, limits for this item ?


Kind Regards,

 

Charles.C


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Posted 07 April 2021 - 12:05 PM

Scampi,

It is absolutely possible to have an RTE product without a kill step. An RTE product is defined as a product that does not receive a process that will significantly reduce the bacterial load prior to packaging. Fresh-cut produce is an excellent example.

Fresh cut produce DOES ( or should) involve a wash step that includes a chemical designed to reduce the bacterial load however. Case in point "Melon cooling with water, if done correctly may reduce microbial loads on the outside surface of melons by 2-3 logs CFU." (Park and Beuchat, 1999, Rodgers et al., 2004)

 

As the poster has mentioned, she's using flour that has been heat treated-which is what my concern was about.  I've got a multitude of commodities under my belt, and I in no way suggested that ALL products RTE involved a kill step


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Posted 07 April 2021 - 01:22 PM

Scampi,
Significant reduction as per the FDA & other literature means 5 log reduction or more, so something like cooking, roasting, etc. Washing in a microbial solution does not significantly reduce the bacterial load. There's is no kill step. It is possible to have no kill step, or significant reduction, in a process and have a safe product. However, in situations like this, the APC counts are expected to be elevated.


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Posted 07 April 2021 - 10:11 PM

Hi amberlyda,

 

Personally, despite I can see some advertising/FDA usages, I would avoid calling this product raw RTE dough since afaik "raw dough " is usually understood as involving cooking. Maybe USA is "special" though. :smile:

 

4 initial comments -

 

(1) As stated, yr internal APC surface data appears meaningless from a "unit" POV. Maybe there is some data misunderstanding somewhere.

 

(2) Since you apparently have in-house micro. lab capability for APC, why not do some finished product testing yourself ?

 

(3) If yr samples sent to lab are genuinely representative of a stable process, yr variable results on same sample would suggest to find another lab. A possible check is to deliberately prepare one reliable, well-mixed process sample and divide into 2 portions which are both submitted randomly within a larger batch. Additionally, if you have any item which you are confident possesses an appropriately low APC value, can include as a dummy reference sample.

(I assume you are aware that APC counts are notorious for exhibiting considerable scatter)

 

(4) Offhand,  If there are a variety of mixed inputs, I suspect yr APC limit is quite demanding for the process such as presently described. What kind of "satisfactory" end product results were mostly achieved previously, eg <5000cfu/gram, in the range 5000-10,000cfu/gram, or ??

(JFI, IMEX of RTE seafood, a limit of 100,000 cfu/g (or more) is quite common although figures down to 10000/g can also be found)

 

As I understand, yr process, basically, is to mix various ingredients together then freeze and store.

 

The usual approach in case of micro problems at end of process is to start from the beginning eg -

 

(a) actual test data for micro, eg APC,  for input ingredients (Not just COA values).

 

If input results are all consistently, acceptably, low, then typically implies either (i) Process contamination due XYZ or (ii) micro growth in Process due time/temperature (delays?) problems. This requires a close look at the Process staging/temperature control.

 

Hopefully when yr process gave satisfactory end data, you have some records for (a) to enable a comparison/evaluation. Either way you still need some current, reliable, input data.

 

I did a quick search for micro.specs, eg APC, for RTE "edible" dough but could not find a single one. I anticipate there are no official, eg FDA, limits for this item ?

There are no FDA guidelines for our product in reguards to micro testing.  As I am looking through our data I have found that the previous QA manager came up with the 10,000cfu/g limit becuase she was "assuming" that the bacteria could be salmonella, or e.coli based on the fact that chocolate can have salmonella and employees could transfer e.coli.  I have found that other countries do have apc standards for frozen desserts and they have tolerances up to 100,000 even up to 1,000,000 cfu/g depending on the category.  I need to do more research and need more professional input but everything i am researching is pointing to the fact that we need to change our testing policies and change our tolerances 



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Posted 07 April 2021 - 11:38 PM

I recommend the following:

1) ask your 3rd party lab to perform gram stain testing on the high APC plates.  Gram staining will help you assess if the high counts could be pathogens.

2) Perform swabbing with spongicles from the lab after cleaning and see what counts you get for APC.  

3) Speak with a Hygiena ATP representative (after signing an NDA) on what your are experiencing in general terms.

4) Evaluate finished good sampling technique used by each person collecting the samples.

5) May have to seriously consider shortening the production run and stop and clean if there are pathogens present with increased test results.  APC is just an indicator test for weather something is "dirty".

 

Maybe the prior Quality Manager wanted to be conservative and reduced the tolerance from 100,000 by one log to be conservative? 

 

Best of luck to you in your endeavor.



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Posted 08 April 2021 - 03:04 AM

There are no FDA guidelines for our product in reguards to micro testing.  As I am looking through our data I have found that the previous QA manager came up with the 10,000cfu/g limit becuase she was "assuming" that the bacteria could be salmonella, or e.coli based on the fact that chocolate can have salmonella and employees could transfer e.coli.  I have found that other countries do have apc standards for frozen desserts and they have tolerances up to 100,000 even up to 1,000,000 cfu/g depending on the category.  I need to do more research and need more professional input but everything i am researching is pointing to the fact that we need to change our testing policies and change our tolerances 

 

Hi amberlyda,

 

It looks like you need to hire an appropriately qualified microbiologist. The "assumptions" you refer to are somewhat bizarre.

 

Do you have in-house micro. facilities  for items like APC, coliform, E.coli, Salmonella ? This would be extremely useful if present.

 

Regardless of specs, if yr current end product APC results have changed from, say, consistently < 5000cfu/gram to > 50,000cfu/g then something has significantly changed. It's all about the numbers/variability and often especially for the input materials.

 

If end product data such as coliform/E,coli,Staph.aureus are all <3MPN/gram (=undetected) this suggests yr hygiene control is functional. Confirmation should come from swabbing of food contact surfaces giving acceptable values for APC, coliform etc + ATP data

 

What level(s) are the claimed COA, APC values for inputs ?

 

I'm curious as to what yr other lines are producing ? Also RTE products ? Similarly low APC specifications, eg < 10,000cfu/gram ?

 

Do yr customers provide any feedback / their own micro. requirements ?


Kind Regards,

 

Charles.C


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Posted 08 April 2021 - 03:51 PM

Hi amberlyda,

 

It looks like you need to hire an appropriately qualified microbiologist. The "assumptions" you refer to are somewhat bizarre.

 

Do you have in-house micro. facilities  for items like APC, coliform, E.coli, Salmonella ? This would be extremely useful if present.

 

Regardless of specs, if yr current end product APC results have changed from, say, consistently < 5000cfu/gram to > 50,000cfu/g then something has significantly changed. It's all about the numbers/variability and often especially for the input materials.

 

If end product data such as coliform/E,coli,Staph.aureus are all <3MPN/gram (=undetected) this suggests yr hygiene control is functional. Confirmation should come from swabbing of food contact surfaces giving acceptable values for APC, coliform etc + ATP data

 

What level(s) are the claimed COA, APC values for inputs ?

 

I'm curious as to what yr other lines are producing ? Also RTE products ? Similarly low APC specifications, eg < 10,000cfu/gram ?

 

Do yr customers provide any feedback / their own micro. requirements ?

I just went though all of our specs for every ingredient and some of them allow up to 20,000 cfu/g. Most ingredients allow up to <5,000 cfu/g-10,000cfu/g.  The numbers only came back significantly higher when we changed this particular production line.  We added conveyors, a bucket scale etc.  We used to hand pack the dough pieces directly from the nitrogen tunnel.  We also increased the number of bowls we produce and there are times that the bowl is sitting out for up to 20 min before it is fed into the hopper for cutting.  Our other line that produces this product has significantly lower results, but it relies on the old way of hand packing the product.  We are building a new line to exclusively handle this product and it will have a longer production time in terms of transferring to conveyors etc, but we will be producing 2x the amount that we currently do now.  

I was under the impression that our customers had given us micro specs to abide by, but that was incorrect.  All of the specs were set by the old QA manager 






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