8 replies to this topic

[Jewl578]

Hi all,
We are a small facility that currently manufactures RTE and Heat Treated USDA products.
I am trying to put together a HACCP Plan for an FDA product and need to know if I'm going in the right direction.
This is for a nonmeat/nonseafood product that will be assembled, produced and then immediately frozen raw in a blast freezer, all on a separate line from our USDA products.
It will be fully cooked by the consumer, baked or fried, their choice.
The only CCP I have come up with is the metal detect. Does this sound right. I have tried researching this on the web and haven't come up with much in common with this type of process/product.
I am thinking monitoring procedures will need to be put in place to track ingredient temperatures/time from coolers to pre-freezing, then again post freeze monitoring, because this is a new product and we want to establish that the ingredients/product are not sitting for long periods of time before being frozen.
Not a whole lot of experience here, all I know has been pretty much self taught with loads of research, some knowledge gathered from auditors, and a wealth of information from this site.

Thank you all so much!

[Charles.C]

Hi all,
We are a small facility that currently manufactures RTE and Heat Treated USDA products.
I am trying to put together a HACCP Plan for an FDA product and need to know if I'm going in the right direction.
This is for a nonmeat/nonseafood product that will be assembled, produced and then immediately frozen raw in a blast freezer, all on a separate line from our USDA products.
It will be fully cooked by the consumer, baked or fried, their choice.
The only CCP I have come up with is the metal detect. Does this sound right. I have tried researching this on the web and haven't come up with much in common with this type of process/product.
I am thinking monitoring procedures will need to be put in place to track ingredient temperatures/time from coolers to pre-freezing, then again post freeze monitoring, because this is a new product and we want to establish that the ingredients/product are not sitting for long periods of time before being frozen.
Not a whole lot of experience here, all I know has been pretty much self taught with loads of research, some knowledge gathered from auditors, and a wealth of information from this site.

Thank you all so much!

Dear jbickle,

Unfortunately, it's difficult to guess hazards without knowing the product / process ?

Rgds / Charles.C

[Jewl578]

This is a cheese and dough product, simple mixing, extrusion and right onto the blast freeze belt (-90°F), through a metal detector, packaged by hand.
SSOP's, GMP's, Temp monitoring reduces pathogen hazards, along with supplier approvals and COA's.
We are used to running meat and poultry RTE or Heat Treated products and are used to having the blast freeze as a CCP.
Since this is a non meat, raw product, would we still need the blast freeze as a CCP for pathogens? I don't see that it would be, and our USDA Inspector doesn't seem to think so either.
I just want to know if I am headed in the right direction as this HACCP Plan is in the planning stages only so far.
I am still pretty inexperienced and maybe I am missing what you need to know? Sorry

[Charles.C]

This is a cheese and dough product, simple mixing, extrusion and right onto the blast freeze belt (-90°F), through a metal detector, packaged by hand.
SSOP's, GMP's, Temp monitoring reduces pathogen hazards, along with supplier approvals and COA's.
We are used to running meat and poultry RTE or Heat Treated products and are used to having the blast freeze as a CCP.
Since this is a non meat, raw product, would we still need the blast freeze as a CCP for pathogens? I don't see that it would be, and our USDA Inspector doesn't seem to think so either.
I just want to know if I am headed in the right direction as this HACCP Plan is in the planning stages only so far.
I am still pretty inexperienced and maybe I am missing what you need to know? Sorry

Thks for clarification.

I assume you are producing the final product, ie ready for retail sale. You do not indicate any particular standard so I assume traditional HACCP.

As I think you have already deduced, the basic answer(s) to yr CCP question depends on the hazard analysis (HA) although legislatory CCP(s) may be involved (as you no doubt encountered for meat production?). I’m not in the USA so regret no idea of regulatory HACCP CCPs for cheese/dough processes (if any).

The HA for manufacturing plants is typically focused on BCPA hazards deriving from –

(1) The entire process including reception of input ingredients up to finished product / shipment and IMEX nowadays usually includes any (hazard control) contribution from the consumer’s usage of the product. (Sometimes the purchasing function is also included.)
(2) Input materials, eg ingredients, packaging
(3) Equipment
(4) Environment
(5) Personnel

Hazards from Items (4-5) are hopefully of a hygienic nature so that controllable by PRP programs ( including aspects such as L.mono). Similarly for hygienic aspects of (3).

Subsequently, it is customary to evaluate (1-3) for significant BCPA hazards as related to the process . There are many examples of haccp plans on this forum illustrating the basic layout which I expect you know already.

I assume you are also aware that selecting CCPs for HACCP can be a subjective topic. People do not always agree or hv different (equally acceptable) interpretations. A popular approach is to seek model haccp plans similar to yr own situation.

For yr product how about allergens (eg labelling CCP).?
If it is considered inevitable that ingredients do contain microbial pathogens, this may hv implications regarding maximum time of exposure prior to freezing.

If, as per yr post (?), the consumer usage will reliably eliminate any low levels of pathogens, eg from the ingredients, many experts accept that such input hazards not be classified as significant for CCP purposes (ie innocent until proven guilty).

I hv never used the freezing step as a CCP but I know some people do. I asked one company for their justification and the answer was “Customer’s request”. Another justification was “frequent compressor breakdowns” (unusually honest). How about yourself for meat ?

As you suggest, metal detectors are often regarded as a guaranteed CCP, rightly or otherwise.

Hope these few ideas are helpful.

Rgds / Charles.C

[Jewl578]

Charles,
Thanks for the reply. Many useful comments!

As to the type of standard used for this product, it's going to be produced under a traditional HACCP Plan.
I had the opportunity to write our most current products HACCP Plan (for RTE Meat & Poultry) which, without any training past Level 1 HACCP, I musy say, was a learning experiance indeed. It has passed a USDA Food Safety Audit with flying colors, as well as BRC, and 3 other customer audits. I utylized the knowledge of our USDA Inspector a great deal as well as hours upon hours of research.

Anyways, to get along in explaining, this is a potential product most likely (99% likely) to evolve into regular production and I wanted to have a general HACCP Plan ready so I didn't have to scramble to produce one.
I have completed the HA for BCPA's since the process is completely the same as our other products, except no cooking and no meat. Same type of ingredients, equipment.

I'll have some monitoring steps in the process to show the temperture of mixture at the end of mixing a batch. How long it takes to use a batch, the temperature at end of the batch, how long through the blast freeze, temp out of freeze, etc.

I feel that because we are trying to minimize any pathogen hazards by monitoring ingredients through COA's and inspection at recieving, handling in the facilty, production process, employee handling, packaging, storage, etc. we will have done all we can to eliminate/reduce as many hazards as possible thorugh our procedures and processes. Use of GMP's, SSOP"s, SOP's etc.

That said...I have decided on NO CCP for freezing. The customer will finish off any remaining pathogens,

We do however use freeze as a CCP for our RTE meat products, USDA requires the use of the one of the following:
Our facility uses Alternative 2 with freeze being the post lethality treatment.

Alternatives 1, 2, and 3

:

In order to maintain the sanitary conditions necessary to meet the requirements of 9 CFR Part 430, an establishment producing post-lethality exposed RTE product must comply with the requirements provided in one of the three following alternatives and complete FSIS Form 10,240-1:

Alternative 1

: The components required under Alternative 1 would be: A and B,

Alternative 2

: The components required under Alternative 2 would be: A or B and C.

Alternative 3

: The components required under Alternative 3 would be: C.

The following information contains the requirements of each Alternative component:

A)

A post-lethality treatment, must:

• Identify

Lm as a Hazard reasonably likely to occur in the hazard analysis

• Be included in a HACCP plan with the point of treatment as a CCP

• Be validated as effective in reducing or eliminating

Lm

B)

The anti-microbial agent or process:

• May not reduce

Lm but is still effective through limiting the outgrowth of organisms that survive the post-lethality process

• May be in the SSOP, or

• May be in a prerequisite program, or

• A validated HACCP plan

C-1)

a sanitation program must:

• Provide testing of food contact surfaces (FCS) and a record keeping system to match samples to test results

• Identifies conditions under which hold and test procedures will be implemented following a positive test for

Lm or an indicator organism such as L. spp.

• State a frequency of test sampling, and

• Identify the size and all FCS sampling sites that could contaminate product

• Include an explanation of why the testing frequency is sufficient to ensure that effective control of

Lm or of indicator organisms is maintained

C-2) an establishment producing a Hotdog or Deli-type Product, must:

• Verify corrective actions after first L. spp. positive sample of a FCS by conducting follow-up sampling

• If there is a follow-up positive, hold product until problem is corrected

• Test affected product lots with with a sampling procedure that ensures the lot is not adulterated with Lm

We currently perform ATP at Pre-Op, swab for Lm. (FC), L.spp.(NFC) and APC (FC) at the end of each shift and do finished product testing for L.m 3 times per shift.

As for the allergens, these are addressed on the labels; also, our other products have the same allergens so no cross-contamination there, in storage or otherwise.

We do use metal detect as a CCP, to me it's a given since moving parts on the equipment are in the equation. We have also had problems with a supplier who unbeknown to us, were not following their own metal detection procedures and had problems with metal in the ingredient. They admitted to a disgruntled employee throwing miscellaneous pieces of metal into their product. Had we not been using a metal detector, pieces as big as 18mm would have passed. We no longer use that supplier!!! Thankfully we were able to track down the source, all product was still in our possession and no recall!
There have been enough instances to warrent keeping it as a CCP for ALL products over the years.

Long post, I tend to get wordy but that's it in a nutshell!

[Charles.C]

Dear jbickle,

Thks for the interesting reply.

I deduce yr other meat products must have coatings if cheese/dough allergens are prevalent across the process area. Good fortune from a QA viewpoint.

Truly a lot of swabbing and micro. So much for the HACCP / minimal end-product testing. The FSIS fascination with L.mono is famous and probably unique, even if past recall history supplies "due cause". I doubt anyone outside USA envies you over this one.

I concur with yr comments on metal detector. Fragments from overnight maintenance on freezing systems are my top bugbear.
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Rgds / Charles.C

[herb b]

Have you validated your freezing process? i.e. How long it takes to freeze solid from the initial feeding of product. I would assume you are dealing with egg also? Temperature monitoring of the freezing and holding area would have to be considered also.

[KTD]

Dear JBickle -

I think Charles.C is on track with allergens - sounds like you have at least 2 in the new product...wheat & diary. Given the tremendous upswing in allergen and allergen-labeling related recalls in both FSIS and FDA products over the past year, I would take a hard look at allergen-control or allergen-labeling as a CCP. In addition, there have been several recalls related to Lm in cheeses - might want to look at that.

Have you looked at the FDA website for any guidance documents they might have related to your type of product? I am not sure where in the US you are, but there are a number of FDA coordinators across the country who can give some help, or point in the right direction. You should find them listed on the FDA website.

With your plant now becoming a dual-jurisdiction plant (FSIS & FDA), have you completed your FDA facility registration? The new operation will be covered under the FSMA requirements...as those are just emerging, need to keep a close eye out. FDA on-site inspection will not have to be arranged - inspectors will stop by unannounced periodically (couple times a year to several years apart - no rational) to inspect the facility and review records.


Hey Charles.C -

I like the new pic - family photo or wishful thinking?

[Jewl578]

To Charles, "Interesting reply" .....that may be my inexperience showing through, but we get the job done. I have help with coonsultations occasionally as finaces permit. It was with much reluctance I accepted the QA job, but I do try my best! We are proud of what we do, and want to do it right!!!

Herb,
Yes we have validated temps from beginning to end. We will be processing in 45-50°F room, which is also monitored. All temps will be monitored from beginning to end. Also there are no eggs in the mix.

To KTD,
All products to date have the same allergens; dairy and wheat, so no big concerns over cross contamination. Still though, we have an Allergen Control Policy in place.
This product will also be run on a separate line in a separate room. Lableing is a given, all Allergens listed.
We are registered and up to date with FDA. We've been dual jurisdiction for some time, at least 4 years now and no sign of an FDA Inspector as yet. I have searched the FDA web site, and find it hard to follow, but I keep trying, and still go to our USDA Inspector for direction at times even though the 2 are entirely different, he's very helpful. I also spend hours researching this site, and many other to get a fuller picture of what it is I'm trying to analize and/or gather information on.
Google is my middle name .



Thank you all!