10 replies to this topic

[amberlyda]

Hello,

 

I have taken over as the QA/SQF practitioner for a RTE baked goods factory.  We have a RTE cookie dough that is produced daily.  There is no kill step for this product.  It is mixed, cut, flash frozen and packaged.  the consumer does not bake it.  There is no egg, and has heat treated flour.  Currently every single batch is being sent out daily to be tested for APC, Coliform and listeria spp.  so some days we are sending in about 100 batches daily to be tested.  I am changing our EMP to be more robust and have daily checks on the line including ATP, APC and Coliform for zone 1.  Listeria SPP would be on a monthly or weekly. Also doing validatio testing to make sure that the final product is within guidelines for APC, Coliform and listeria spp (or jump right to L.mono).

Im basing this frequency on FDA and AIB (our certifying body) guidelines. 

This is from only doing ATP tests along with final product testing and quarterly testing of listeria spp.

 

We produce several other products that are baked and none go out for finished product testing.

 

We do not have any contracts that say that we must test all finished products.

 

Do i need to continue to test every batch?  It is costing the company a fortune.

Can we switch over to a better Environmental Program and do less product testing.

 

Of course i wouldnt change anything until i can show statistically with a hazard analysis that we can change our program etc.

 

what do other factories test for in this space?  How often do you test final products?  

 

I have talked to other QA managers And they said we are massively over testing and will probably test ourselves into trouble if we arent careful.

 

thankyou for any advise

Edited by amberlyda, 08 December 2021 - 01:30 PM.

[olenazh]

I'm working for 2 companies. One's testing every batch of each product (10-30 samples a day), all samples are submitted to the external lab. Another one is sending to the external lab just 2-3 products a month (but has an internal lab where each batch of ice cream is tested on a daily basis). Really, it depends on company's budget (as it's quite costly), your country regulations, and customer requirements (one of my clients has a customer, requesting all their products' batches to be tested). In Canada, there's no regulatory requirement to test all finished products for pathogens. If you have a history of negative testing results, you might switch to less frequent testing schedule. Let's see what other members suggest...

[Scotty_SQF]

I would say if your product is low risk that you can definitely cut down how often you are testing the product.  I worked at company that made a baked product that we froze and the product was low risk.  We did do ATP testing every morning before start-up and did environmental monitoring swabs quarterly.  We ended up only sending out finished product once a year. This was sufficient for our SQF certification.  I would say as long as you are documenting what you are doing and providing justification as to why you have the frequency set (risk analysis, etc.) you would be good.

[Charles.C]

I would say if your product is low risk that you can definitely cut down how often you are testing the product.  I worked at company that made a baked product that we froze and the product was low risk.  We did do ATP testing every morning before start-up and did environmental monitoring swabs quarterly.  We ended up only sending out finished product once a year. This was sufficient for our SQF certification.  I would say as long as you are documenting what you are doing and providing justification as to why you have the frequency set (risk analysis, etc.) you would be good.

Hi Scotty,

 

Thks yr input.

Do you think RTE product as described in OP can be HACCP justified as Low Risk ?

 

@amberlyda     - Is yr product internally evaluated as HACCP Low Risk ?

 

I anticipate yr Process is under jurisdiction of FDA ? Do FDA consider this product to be Low Risk ? What EMPG micro. menu/sampling density do they expect ?

[amberlyda]

Hi Scotty,

 

Thks yr input.

Do you think RTE product as described in OP can be HACCP justified as Low Risk ?

 

@amberlyda     - Is yr product internally evaluated as HACCP Low Risk ?

 

I anticipate yr Process is under jurisdiction of FDA ? Do FDA consider this product to be Low Risk ? What EMPG micro. menu/sampling density do they expect ?

Internal evaluation is lower per our haccp plan. FDA has zero guidance for our product which is why im reaching out

[Charles.C]

Internal evaluation is lower per our haccp plan. FDA has zero guidance for our product which is why im reaching out

Hi amberlyda,

 

Can you provide a little more detail as to the Product (eg Aw, shelf stable^##?) / Process (eg handling steps, validation heat-treated flour**) ?

 

Offhand I tend to classify all RTE products as high risk unless proven/validated to be the opposite, for example biscuits.

(There are obviously some Big Boys who have already established this item but not my direct area of expertise)

 

I find it difficult to believe that FDA have no opinion. So how do they decide on their EMPG sampling plan ? 10 samples/Salmonella-Listeria per visit ?

 

** eg something like -

 

 2018-am-safeguard-brochure-update-v-5-final-4-27-18.pdf   612.76KB   64 downloads

 

PS^## - I note other similar products seem to be refrigerated.

Edited by Charles.C, 09 December 2021 - 05:44 PM.
added

[Scampi]

You ay find the CFIA guidance helpful

 

https://inspection.c...4/1528201904208

 

https://inspection.c...2/1540575299761

[Scampi]

Use the FDA guidance if you can't find anything from the FDA

 

https://www.fsis.usd..._RTETesting.pdf

 

https://www.fda.gov/...ready-eat-foods

This above link is directly to the FDA draft guidance, and does speak to what you should be doing. It also speaks to HOLD AND TEST for RTE meat and poultry

[Charles.C]

Hello,

 

I have taken over as the QA/SQF practitioner for a RTE baked goods factory.  We have a RTE cookie dough that is produced daily.  There is no kill step for this product.  It is mixed, cut, flash frozen and packaged.  the consumer does not bake it.  There is no egg, and has heat treated flour.  Currently every single batch is being sent out daily to be tested for APC, Coliform and listeria spp.  so some days we are sending in about 100 batches daily to be tested.  I am changing our EMP to be more robust and have daily checks on the line including ATP, APC and Coliform for zone 1.  Listeria SPP would be on a monthly or weekly. Also doing validatio testing to make sure that the final product is within guidelines for APC, Coliform and listeria spp (or jump right to L.mono).

Im basing this frequency on FDA and AIB (our certifying body) guidelines. 

This is from only doing ATP tests along with final product testing and quarterly testing of listeria spp.

 

We produce several other products that are baked and none go out for finished product testing.

 

We do not have any contracts that say that we must test all finished products.

 

Do i need to continue to test every batch?  It is costing the company a fortune.

Can we switch over to a better Environmental Program and do less product testing.

 

Of course i wouldnt change anything until i can show statistically with a hazard analysis that we can change our program etc.

 

what do other factories test for in this space?  How often do you test final products?  

 

I have talked to other QA managers And they said we are massively over testing and will probably test ourselves into trouble if we arent careful.

 

thankyou for any advise

Hi amberlyda,

 

i deduce the "fortune" is primarily associated with the batch testing.

 

I don't quite understand why you have so many batches/day ? Very small batches ?

 

Most typical internal micro. labs IMEX would immediately collapse with this loading.

 

Are there significant changes in the process between batches ?

Are there significant deviations in the batch micro. results ?

I can understand that a new process would initially be oversampled but if the results are all close together and satisfactory then seems illogical to carry out so much sampling/testing.

It is also IMEX risky to base a batch result on only one sample but this also depends on the results.

[amberlyda]

Hi amberlyda,

 

i deduce the "fortune" is primarily associated with the batch testing.

 

I don't quite understand why you have so many batches/day ? Very small batches ?

 

Most typical internal micro. labs IMEX would immediately collapse with this loading.

 

Are there significant changes in the process between batches ?

Are there significant deviations in the batch micro. results ?

I can understand that a new process would initially be oversampled but if the results are all close together and satisfactory then seems illogical to carry out so much sampling/testing.

It is also IMEX risky to base a batch result on only one sample but this also depends on the results.

Yes; we spend thousands a month on 3rd party lab testing on our finished goods for APC, Coliform and listeria spp.  We test every single bowl we make of this edible cookie dough.  We are a growing factory so we do many smaller batches of the same type of product on several lines almost every day. Each bowl is only about 300-400 pounds. The process is the exact same for all batches, the only thing that changes if a few ingredients depending on the sku being made.  Most of the micro results are roughly the same.  If anything tests outside of the parameters then we retest and send in an additional batch.  This is just the system I took over and I want to change.  Our SOPs currently say test every finished batch and do ATP swabs daily on various equipment and listeria spp indicator swabs once a quarter.  I would like to flip this to daily testing of  zone 1 for APC/Coliform (which has been regularly testing <10 cfu) and ATP swabs during pre-op, and go to possibly quarterly testing for validation of finished goods and if i need to some of our raw materials.  Listeria spp for zones 2/3 would either be monthly or quarterly-depending on results found.

 

I am just always overly cautious changing some of these things since we have passed SQF with our current systems in place.  so i want to make sure that I consult others in the industry to make sure i am within industry standards.

[Charles.C]

Hi amberlyda,

 

I just noticed that you previously initiated a lengthy discussion on the micro. aspects of this RTE product, ie -

 

https://www.ifsqn.co...gg/#entry172358

 

As far as SQF is concerned I anticipate that the finished product micro. results (vis-a-vis being in compliance to specification) are relevant to Verification of your HACCP plan (and perhaps storage micro data to shelf life validation).

 

Obviously this initially requires an appropriate defined micro. specification.

 

I have further sought published micro. specifications for various branded edible cookie doughs but data seems elusive. Nonetheless, I anticipate that in USA any  spec. will include nil detection of both L.monocytogenes and Salmonella. So, inter alia, you should minimally be requesting analyses for zero-tolerant pathogens like Salmonella and L.mono (unless nil detection of Listeria). And in view of a previous recall of non-edible cookie dough for pathogenic E.coli perhaps the latter also.

 

I suggest you investigate (from yr encyclopedia of batch data) whether separate batches of finished product generated from same ingredients do have "same" (and satisfactory) micro data. If so, this should enable some (massive?) grouping of batches from a micro. sampling POV.

 

Again, above decisions should presumably also be commensurate with FDA expectations which I would anticipate are more stringent  than those of SQF (?)

 

PS - Out of curiosity, do you need FDA/USDA approval to market this kind of product as ready-to-eat ?

 

PPS - this link seemed quite useful/informative -

 

https://extension.sd...at-cookie-dough

Edited by Charles.C, 10 December 2021 - 06:01 PM.
added