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Looking to Potentially Remove a CCP from Plan

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FSQMan21

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Posted 26 March 2020 - 10:05 PM

Hello,

 

I am performing a review of a HACCP plan that is currently under a "fully-cooked, not shelf stable" category on our USDA GOI.

 

The previous team at this facility determined that temperature would be a valid CCP for our process to control the growth of S. aureus. We currently receive fully cooked, cured and uncured/naturally cured bacon bits from suppliers in bulk packaging (5-10lbs. bags), and fill them into smaller portion controlled packaging for use in a condiment kit for a salad.

 

We currently receive COAs from one supplier stating that their water activity is <0.8500 which is the benchmark for shelf-stability for the USDA from my understanding. However, there is a second supplier that provides different SKUs we use (cured and uncured) which has a spec that states their water activity will be <0.9000. They have sent me some justification they have in regards to how this product can still be considered shelf-stable via their processes. They are also a USDA inspected facility.

 

Can I still use their justification to help in the removal of our current CCP for temperature given the product is essentially "shelf-stable"? We do have our SSOPs, GMPs, and PEM Programs as pre-requisites.

 

Any help/feedback that could be provided would be appreciated. I can attach the plan in a future post if needed.

 

Thanks in advance to everyone!

 

 



Charles.C

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Posted 27 March 2020 - 09:39 AM

Hello,

 

I am performing a review of a HACCP plan that is currently under a "fully-cooked, not shelf stable" category on our USDA GOI.

 

The previous team at this facility determined that temperature would be a valid CCP for our process to control the growth of S. aureus. We currently receive fully cooked, cured and uncured/naturally cured bacon bits from suppliers in bulk packaging (5-10lbs. bags), and fill them into smaller portion controlled packaging for use in a condiment kit for a salad.

 

We currently receive COAs from one supplier stating that their water activity is <0.8500 which is the benchmark for shelf-stability for the USDA from my understanding. However, there is a second supplier that provides different SKUs we use (cured and uncured) which has a spec that states their water activity will be <0.9000. They have sent me some justification they have in regards to how this product can still be considered shelf-stable via their processes. They are also a USDA inspected facility.

 

Can I still use their justification to help in the removal of our current CCP for temperature given the product is essentially "shelf-stable"? We do have our SSOPs, GMPs, and PEM Programs as pre-requisites.

 

Any help/feedback that could be provided would be appreciated. I can attach the plan in a future post if needed.

 

Thanks in advance to everyone!

 

Hi FSQM,

 

Not my product area but I noticed these comments on USDA website page -

 

How is cooked bacon made shelf stable?

To make bacon safe to store at room temperature (shelf stable), it is precooked in the plant to have a water activity at or below 0.85 to control Staphylococcus aureus. The cooked yield is 40% of the raw weight

 

 

How to Handle Bacon Safely
RAW BACON

  • Select the bacon just before checking out at the supermarket register.
  • Take the bacon home immediately and refrigerate it at 40 °F or below.
  • Use within 7 days or freeze (0 °F).

COOKED BACON PRODUCTS

  • Read the product label for handling instructions.
  • For refrigerated, cooked bacon, select it just before checking out at the supermarket register.
  • Take the bacon home immediately and refrigerate it at 40 °F or below.
  • For shelf-stable, cooked bacon, store the product at 85 °F or below. Refrigerate after opening.
  • Observe the manufacturer's recommended "use-by" date

 

 

I presume the 1st  ^^^(red) above was sort of based on the first "Quote" above ? ( although < 0.9 seems incompatible with < 0.85 ? )

 

The 85 degF requirement indeed seems rather odd for a shelf-stable product.

 

What was the previous team's  justification for the existing temperature CCP ?

 

I also noticed this elsewhere  -

PRE-COOKED BACON

USDA defines pre-cooked bacon as having been cooked to a finished yield of 40 percent or less. When a 1-pound package of raw bacon is cooked to 0.4 pounds or less, it
may be labeled as fully cooked bacon. Most pre-cooked bacon is considered shelf stable (may be stored safely at room temperature) because it is vacuum-sealed, has a
high-brine concentration, and the water activity is low enough to prevent the outgrowth of pathogenic organisms.

 

The "shelf-stable" category seems to be semantically flexible, eg the use of "considered", 85degF, etc

 

Is current product vacuum pack, high brine ?


Kind Regards,

 

Charles.C


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FSQMan21

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Posted 27 March 2020 - 02:37 PM

Thank you for all of that info, Charles.

 

The previous regime had determined a temperature of <44.6F to control the growth and proliferation of S. aureus.

 

Our product comes to us, in bulk form, within vacuum sealed bags, but we are de-casing the product from a 5-10 lbs. bag and packing into 0.3-1.0 oz. packets. The room operates under refrigerated conditions, and would continue to do so. The pouches are nitrogen flushed, but not vacuum sealed. Upon running product from the vendor that provides product at <0.90 (only once since I've started this task), we averaged a water activity of ~<0.8430, with a range of 0.8058-0.8669 across 6 hours of run-time.

 

We shut down nightly for sanitation and pre-op SSOPs and operational SSOPs, have controlled gowning and GMPs in place, also swab sites monthly as for our PEM, granted not for S. aureus (currently).

 

We have, in the past, had issues where product was mistakenly left in ambient storage, and deemed acceptable for release to commerce due to bacon's inherently low water activity, and the product being "fully cooked".

 

I have a tendency to ramble, so I will stop now. If there are any other questions, or any more insight, I would greatly appreciate it.



Charles.C

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Posted 27 March 2020 - 04:07 PM

Hi FSQM,

 

Thks yr amplifications.

 

As I understand, yr primary objective is to remove yr temperature CCP.

 

I assume yr haccp plan requires formal USDA approval ?

 

Assuming you are OK with maintaining yr cooked, non-shelf stable category, one validation might be to reference the equivalent model haccp plan on the, afaik, de facto  "USDA"  haccp web site, ie -

 

https://meathaccp.wisc.edu/

 

I attach their (ham) example's hazard analysis below -

 

Attached File  ham_haz_analysis 05-04-12-2.doc   110.5KB   23 downloads

 

I speculate that the hazards noted for the model's packaging step 18 are similar for yr bacon "repackaging" (vac.pac > N2 flush),  if so, the model's hazard analysis may justify yr excluding the  temperature CCP..

 

One possible snag is you will now have a haccp plan with zero  CCPs. Is this a conceptual problem for USDA?

 

If any other posters operationally familiar with this USDA scenario, further input welcome of course.


Kind Regards,

 

Charles.C


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FSQMan21

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Posted 28 March 2020 - 02:03 PM

Currently, the product runs under a fully cooked - not shelf stable category. However, our facility also packaged jerky for some time, so we have a GOI under heat treated - shelf stable. I was hoping to re-classify our bacon under that category with the amendments to the plan.

 

I spoke with an individual from the USDA that is a "enforcement, investigations, and analysis officer" and he said that while everyone thinks they need a CCP, there are justifications and situations in which a CCP is not necessary. Our bacon packets go on in further processing steps to have metal detection performed on them in our finished product (which is under FDA regulation), so the CCP is just further in the processing after applying the mark of inspection to the product. Packs that go directly to a customer for use in their process is metal detected prior to casing/toting, so metal detection for those products is used as a CCP.

 

Kind of convoluted as I type it all out, maybe an attachment of our flow diagram would help. I have attached a draft of my proposed HACCP plan revision's draft. It has a copy of our current flow chart still, as I am going to work on one in Visio once I determine if it is even worth updating.

 

Attached File  Copy of 14-003 HACCP Plan - Bacon DRAFT.xlsx   198.73KB   26 downloads

 

Thanks again for all the input.



WCOULOMBE

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Posted 30 March 2020 - 09:47 PM

There is no right or wrong in deciding whether a step is a CP, CCP or PC as long as the decision is justified.  Certain process steps have always been considered to be a CCP and people tend to stick with those.  What are the controls in place, how is it monitored, etc.  

 

One step may be a control point and the next a preventive control and the final a critical control point.  It comes down to proving there is control of hazards throughout the entire process.  The rest is semantics.



Charles.C

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Posted 31 March 2020 - 01:01 AM

There is no right or wrong in deciding whether a step is a CP, CCP or PC as long as the decision is justified.  Certain process steps have always been considered to be a CCP and people tend to stick with those.  What are the controls in place, how is it monitored, etc.  

 

One step may be a control point and the next a preventive control and the final a critical control point It comes down to proving there is control of hazards throughout the entire process.  The rest is semantics.

 

Hi WC,

 

^^^^ (red) - I would have said it often comes down to the intended auditor/Standard/their semantics.

 

@ FSQM, thks for the excel. Nice layout. I found some of the content rather debatable however I presume the majority of presentation is customised for USDA and/or FSMA. One comment is that "Listeria" is not a hazard.


Kind Regards,

 

Charles.C




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