38 replies to this topic

[kfromNE]

Here's a link to the white paper where you don't have to give them your life to get.  

 

https://remcoproduct...haccp-vs-harpc/

 

Thanks to KfromIA for original post.  I intend to read this now - see if it impacts my limited understanding.

 

Thanks for the better link. I hate giving all that information as well. With some things, I'll "accidentally" put our fax number in when they ask for a phone number.

 

I agree, this will always be a confusion and a topic of discussion on this forum.

[mgourley]

As an FDA regulated facility, I have done away with HACCP. Well not really, but I have converted our legacy HACCP plans to the legislatively required Food Safety Plans.

Food Safety Plans do not require a flow diagram. I just can't see doing a proper hazard analysis if you don't have a flow diagram. So those have been incorporated.
CCP's in the old HACCP plan are still in the new Food Safety Plan. They are just called a Process Control.

 

Because Food Safety Plans differ from traditional HACCP in that they do not consider PRP's "before" you do a hazard analysis, you have to get over that mind set. 
For example, in a bakery operation, you use flour. There has been historical evidence of salmonella in flour. Therefore it may be a hazard.
With HACCP, many people would have just used some PRP like "COA's are inspected before unloading to ensure the material meets the material specification"

 

With Food Safety Plans, a piece of paper is not an adequate control for an identified hazard. This is why if you have identified a hazard with a material (flour), the FDA requires you to "scientifically" show that the identified hazard that "may" exist, is dealt with at some part of the manufacturing process. This is why, at least in bakeries, the baking step is now a Process Control, because it is at this step that an identified hazard will be mitigated.

 

We are also certificated against BRC. The BRC 8 Standard in Section 2 specifically states that "the HACCP Plan (or Food Safety Plan) shall......"  

We have been audited against BRC, FDA (for an actual FSMA Readiness Audit) and by a rather large international bakery company that we co-pack for, and all have accepted my mash up.
 

I simply do not see the need to maintain two plans.

 

If anything, a Food Safety Plan required under FSMA will be, generally, better than a HACCP Plan in identifying hazards, risk assessing them, and implementing controls that reduce or eliminate any identified hazards.

 

I get some people that get their back up about all the different requirements, and I'm right there with you. By the same token, I don't want to see some standard that every food manufacturing facility in the world has to comply with. Imagine what that would look like?

 

Marshall

[CMHeywood]

My opinion:

All CCP's are FSMA preventative controls.

All prerequisite programs are FSMA preventative controls.

Thus not all preventative controls are CCP's.

 

CCP's are for contamination you know will be getting into your process and need to be addressed at the critical control point.  Example - pasteurization of milk.  You can't eliminate bacteria contaminated milk from entering the dairy so you have one critical point in your process where you are eliminating the contamination or reducing it to an acceptable level.

 

Prerequisite programs usually try to prevent contamination or detect it before the contaminated item enters your process.  Example - pest control to prevent rats from entering your building.  You can get to a point where rats are not entering your building.  You are not removing rats at some critical control point in your process.  The pest control is applied to the entire building, not to just one point in your process.

 

Bonus question:  what about rat hairs in your raw materials?  CCP or Prerequisite Program?

[mgourley]

Assuming you have identified that rodent infestation, is a particular problem at a certain process step, then you have bigger problems on hand.

Playing "what if" is not the point of HACCP plans, nor of Food Safety Plans.

 

Marshall

Edited by mgourley, 03 April 2019 - 10:14 PM.

[mgourley]

To answer your bonus question..... if rat hair in your raw materials is an identified physical hazard in your facility, one would assume it's been observed.

In that case, I'd say that that your PRP's and/or Process Controls have failed miserably.

 

Marshall

[CMHeywood]

You can have rat hair come in with your raw materials and still not have rats in your building.  Peanuts are a good example.

 

The intent of my bonus question was to illustrate how much we sometimes sweat over the details of whether a hazard control is CCP, PRP, OPRP, etc.

[mgourley]

Yes, of course, but if rat hair in your raw materials is an identified issue, rather than a "what if", one would assume you would have already changed suppliers of the hairy material.

There is no reason to sweat what the hazard is, either it is reasonably likely to occur or it's not. 

 

Marshall

[CMHeywood]

Doesn't the FDA allow a certain amount of rat hair or insect parts in food?

 

My bonus question is only to show how anal retentive we get about certain phrases.

 

I agree that the hazard (severity x probability) needs to be adequately controlled.

 

I rather like the FSMA defintion of "preventative controls" to avoid the argument of whether it is a CCP, PRP, OPRP, etc.  

[Charles.C]

As an FDA regulated facility, I have done away with HACCP. Well not really, but I have converted our legacy HACCP plans to the legislatively required Food Safety Plans.

Food Safety Plans do not require a flow diagram. I just can't see doing a proper hazard analysis if you don't have a flow diagram. So those have been incorporated.
CCP's in the old HACCP plan are still in the new Food Safety Plan. They are just called a Process Control.

 

Because Food Safety Plans differ from traditional HACCP in that they do not consider PRP's "before" you do a hazard analysis, you have to get over that mind set. 
For example, in a bakery operation, you use flour. There has been historical evidence of salmonella in flour. Therefore it may be a hazard.
With HACCP, many people would have just used some PRP like "COA's are inspected before unloading to ensure the material meets the material specification"

 

With Food Safety Plans, a piece of paper is not an adequate control for an identified hazard. This is why if you have identified a hazard with a material (flour), the FDA requires you to "scientifically" show that the identified hazard that "may" exist, is dealt with at some part of the manufacturing process. This is why, at least in bakeries, the baking step is now a Process Control, because it is at this step that an identified hazard will be mitigated.

 

We are also certificated against BRC. The BRC 8 Standard in Section 2 specifically states that "the HACCP Plan (or Food Safety Plan) shall......"  

We have been audited against BRC, FDA (for an actual FSMA Readiness Audit) and by a rather large international bakery company that we co-pack for, and all have accepted my mash up.
 

I simply do not see the need to maintain two plans.

 

If anything, a Food Safety Plan required under FSMA will be, generally, better than a HACCP Plan in identifying hazards, risk assessing them, and implementing controls that reduce or eliminate any identified hazards.

 

I get some people that get their back up about all the different requirements, and I'm right there with you. By the same token, I don't want to see some standard that every food manufacturing facility in the world has to comply with. Imagine what that would look like?

 

Marshall

 

Hi Marshall,

 

I get it. You prefer one Plan and that is FSMA. .

 

Fortunately, from a US haccp POV, I've mainly worked only with Seafood. Along with the, IMO, perfectly acceptable PRP mindset.

 

Maybe worth mentioning that the FSMA's inclusion of "significantly" in their definition of a Preventative Control was promoted as an extension to Codex haccp by the ICMSF pre-2000 (> "CCP1, CCP2"). The Idea was rapidly  abandoned as unworkable in practice, albeit a convenient fudge in certain situations (as IIRC utilised by USDA for many years). BRC seem to have also now re-introduced it in a pseudo-quantitative form.

 

As indicated in Renco,  do FSMA really consider decomposition as a potential safety hazard for a PCP ?

 

@ CM Heywood - I like yr anal side-comments but do note that there are numerous published versions of harpc which incorporate the fearsome OPRP.. Additionally, FSMA's  "in the absence of.." within the intro to "hazards" has also generated criticisms of being incomprehensible.

And yes, afaik FDA has a defect limit for rat hairs. Grounds of unavoidability (flexible adulteration)..

[Scampi]

ALL countries have "acceptable" limits for "filth" in finished products............BECAUSE you can plan for all sorts of things, but we are NOT psychic and cannot see the unforeseeable.

https://globalnews.c...in-food-canada/

[Charles.C]

Hi Scampi,

 

Interesting Link.

 

Opinions regarding actionable levels  seem to vary, eg           -

 

Mushrooms

Canada - Mushrooms can’t have more than 10 maggots in 100 grams of mushrooms.

USA - Average of over 20 or more maggots of any size per 100 grams of drained mushrooms and proportionate liquid

 

Chocolate

Canada - more than 1/100 of a gram of rodent hair in chocolate

USA - Average is 1 or more rodent hairs per 100 grams in 6, 100-gram subsamples examined
OR
Any 1 subsample contains 3 or more rodent hairs

 

CFIA

“There is so no such thing as zero risks, there is always a risk. So they [CFIA] allow themselves to work with miniscule thresholds, just in case. And the organic material poses no danger to humans.”

 

Miniscule ??  Hmmm.

[Scampi]

You think that's bad Charles, when I was in poultry, the reinspection program allowed not more than 1 human hair 25 mm long (___________)  or not more than 25 hairs that are only 10 mm long!!!!!!!!!!!  

 

http://www.inspectio...?chap=14#s41c14

 

Scroll down to D.7 never mind the size of the sample relative to the lot

 

My point still is however, that we CANNOT control EVERYTHING.................all we can do is plan and mitigate for KNOWN hazards..................

 

As for human hair in raw poultry combos......................these plants have 200 employees or more (enormous facilities) we all know that they are NOT all wearing the hairnet correctly and we all know we can't possibly police that all of the time  (doesn't make it right, because it's not but we are humans and therefor fallible)

 

AND if governments didn't allow for some leeway a few things would happen in rapid succession 

 

1--companies would simply fold as the cost of manufacture would be too great

 

2--companies start doing really sneaky things when they think no one is watching

 

3--the price at the stores would be unattainable for all

 

4-- there would be a new recall each and every day

 

5-- everyone would return to growing/raising their own foods where they could

 

 

The problem is the general populations sees those numbers and panics................there is no panic, but it is unrealistic to think these sorts of things do not and will not continue to occur. 

[QA_123]

I just printed the FDA  "Defects Levels Handbook".  I'm shocked.

[QA_123]

I just had my USDA inspector tell me that my preventive control has to be called a critical control point.   Any thoughts?

 

I had the exact thing happen.  I have two haccp plans.  One for amenable  one for non-amenable. They are exactly the same except in the non amenable I have 3 ccp's  and in the non-amenable I have 2 ccp's and one pc.  That makes them both happy.  All of the processes are the exact same.