38 replies to this topic

[QA_123]

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

[Jpainter]

USDA requires HACCP which includes CCP's, while FDA has preventive control plans with process preventive controls. Both are achieving the same goal, just mainly a difference in regulatory bodies. Sounds like you are operating from the FDA model (which is more effective in my opinion), but USDA can be very stuck in their ways when it comes to HACCP. 

[Scampi]

Wrong wrong wrong
 
This is what happens when inspectors have not received ANY HACCP training..............they've just undone basic haccp principles in one sweep
 
"Preventive controls: Facilities have the flexibility to tailor preventive controls to address hazards that occur in the products they manufacture. The preventive controls, which must be written, must be implemented to ensure that any hazards requiring a preventive control will be significantly minimized or prevented and help ensure that the food is not adulterated. The rule includes the following preventive controls: 

• Process controls include procedures that ensure the control parameters are met. Process controls can include operations such as cooking, refrigerating, and acidifying foods.  They must include parameters and values (e.g., critical limits), as appropriate to the nature of the applicable control and its role in the facility’s food safety system.   
• Food allergen controls are written procedures the facility must have and implement to control allergen cross-contact and ensure allergens are appropriately listed on the labels of packaged food products.
• Sanitation controls are procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition to minimize or prevent hazards such as environmental pathogens, hazards from employees handling food, and food allergen hazards.  
• Other Controls are controls that are not described above but are necessary to ensure that a hazard requiring a preventive control will be significantly minimized or prevented. "

Which means that ALL of those would then have to be preventative controls........................NUTS
 
https://www.fda.gov/...a/ucm334115.htm

[Jpainter]

Scampi, 

 

That's where FDA vs USDA comes into the picture. The process you described is preventive controls from FDA, USDA still operates under bare bones HACCP. The US food regulatory sector needs a major overhaul to get USDA and FDA on the same page. Having worked in both USDA and FDA regulated facilities, I can say both have their positives and negatives but they are undoubtedly worlds apart on how they view and handle food safety. USDA considers only "process preventive controls" in HACCP, and names them CCP's. Allergen, sanitation and other controls are all covered by pre-requisite programs and not considered in HACCP. I agree its a flawed system, but that is what USDA trains inspectors, and operates on. 

[Scampi]

that's my very point Jpainter..........using the FSMA definitions, OP would have to label ALL controls as preventative controls, not just CCP's

 

The inspector they have clearly doesn't understand the differences!!! 

[QA_123]

She was happy with just calling it a pc/ccp.  It changes nothing.  Our procedures are all still the same.  We actually hired a very reputable place to help me with our food safety plan.  This was in 2016.  He made the plan to basically cover haccp and harpc.  Honestly I am still having alot of trouble understanding the difference.  Every time I think I get it I read something else or watch another video that just confuses me even more than i was before.  

[Scampi]

and then there's lots of chatter to do away with HARPC------------------I wish everyone in the world would use FSEP!!!!!!!!!!!

 

Wouldn't it be grand from a trade and safety scope if the countries would stop trying to reinvent the wheel and just agree on 1 GD standard sheesh

[Charles.C]

Scampi, 

 

That's where FDA vs USDA comes into the picture. The process you described is preventive controls from FDA, USDA still operates under bare bones HACCP. The US food regulatory sector needs a major overhaul to get USDA and FDA on the same page. Having worked in both USDA and FDA regulated facilities, I can say both have their positives and negatives but they are undoubtedly worlds apart on how they view and handle food safety. USDA considers only "process preventive controls" in HACCP, and names them CCP's. Allergen, sanitation and other controls are all covered by pre-requisite programs and not considered in HACCP. I agree its a flawed system, but that is what USDA trains inspectors, and operates on. 

 

Hi Jpainter,

 

Just curious, why do you consider USDA's system flawed ?

 

Personally I have always rather admired FSIS's HACCP publications such as "Validation"  albeit disagreeing with some of their micro. preferences, eg salmonella over L.monocytogenes as a model target pathogen.

 

@ Scampi, I don't understand why the USDA inspector was wrong. I presume he/she was simply implementing the USDA's "traditional"  version of Codex/NACMCF HACCP.  USDA IMO have been very wise to steer well clear of HARPC. (Just like, IIRC, FDA have also done for their Seafood).

Although I certainly agree she was wrong if all traditional PRPs, etc, were required to be changed to CCPs.

[Jpainter]

Charles, 

 

Having worked in industries that operate using HACCP and in industries that operate using a FDA preventive controls plan, I can say that when developing HACCP plans I felt like things like allergens should be evaluated as chemical hazards. At least in all the USDA plants I worked in, this was not the case; the only CCP's set in those plans were cooking and chilling. Allergens are not monitored as well in a HACCP facility vs a Preventive controls facility in my opinion because you are forced to set monitoring procedures and verification within the preventive controls plan. I realize that these two food safety programs when run perfectly would be equally as effective however, I feel that it is easier to overlook pre-requisite programs than it is a food safety plan. Again, this is all based off my opinion and past experience in USDA and FDA regulated facilities. 

[Charles.C]

Charles, 

 

Having worked in industries that operate using HACCP and in industries that operate using a FDA preventive controls plan, I can say that when developing HACCP plans I felt like things like allergens should be evaluated as chemical hazards. At least in all the USDA plants I worked in, this was not the case; the only CCP's set in those plans were cooking and chilling. Allergens are not monitored as well in a HACCP facility vs a Preventive controls facility in my opinion because you are forced to set monitoring procedures and verification within the preventive controls plan. I realize that these two food safety programs when run perfectly would be equally as effective however, I feel that it is easier to overlook pre-requisite programs than it is a food safety plan. Again, this is all based off my opinion and past experience in USDA and FDA regulated facilities. 

 

Yes I agree with you.

 

fssc22000 enables allergens to be specifically included in the hazard analysis but also with a specific "nod" to the appropriate PRP (eg labelling) involved. Sort of best of both worlds. Sadly such benefits are nullified by the additional slog to search for OPRPs.

[QA_123]

I am in the process of making sure my food safety plan covers both haccp and harpc.  Every time I think I have it all figured out I read something new and am totally confused again.  

[Scampi]

All the more reason to use FSEP---------------it is a HACCP based system that requires you to address allergens as chemical hazards!

 

Lots of meat facilities are opting to operate under FSSC because it aligns the best with meat production (which is completely different from everything else)

 

 

Charles, the inspector was wrong because USDA does not use FSIS terms for implementation of the food safety system and is just making the waters muddier

[QAGB]

I am in the process of making sure my food safety plan covers both haccp and harpc.  Every time I think I have it all figured out I read something new and am totally confused again.  

 

Right there with you. It seems everyone I've talked to (auditors and otherwise) have different interpretations of the FSMA preventive controls. I've been through the formal PCQI training and it is still confusing with everyone's interpretations. 

[QA_123]

Right there with you. It seems everyone I've talked to (auditors and otherwise) have different interpretations of the FSMA preventive controls. I've been through the formal PCQI training and it is still confusing with everyone's interpretations. 

 

I have been through the training also.  I took the course when it just came out so I think I should probably take it again.  

[Jpainter]

I have been through the training also.  I took the course when it just came out so I think I should probably take it again.  

 

 

I recently went through the FSMA preventive controls for human food course with a company called Soterian Systems, that I would highly recomend for anyone wanting to see the differences in HACCP and Preventive Controls. Nancy Scharlach is the instructor, and she does a fantastic job of showing the differences between HACCP and Preventive Controls. In fact, she is conducting a class specifically to address converting HACCP to FSMA preventive controls on May 1-2. I am not sure of your location, but she conducts her training in Denver, CO. I will put a link to that course below. 

 

http://events.r20.co...a&llr=qpyuqpuab

[QAGB]

I recently went through the FSMA preventive controls for human food course with a company called Soterian Systems, that I would highly recomend for anyone wanting to see the differences in HACCP and Preventive Controls. Nancy Scharlach is the instructor, and she does a fantastic job of showing the differences between HACCP and Preventive Controls. In fact, she is conducting a class specifically to address converting HACCP to FSMA preventive controls on May 1-2. I am not sure of your location, but she conducts her training in Denver, CO. I will put a link to that course below. 

 

http://events.r20.co...a&llr=qpyuqpuab

 

I should probably take a refresher too, so I will keep this in mind. Thanks JPainter!

[LostMyMind]

I took both classes with the same instructor and left with the impression that

 

A.) CCPs were to be focused on the "truly critical" (her words) steps to prevent, eliminate, or reduce.  PC's were broader and focused more on proactive preventive measures in areas that didn't always fit in the historic definition of CCPs.

 

B.) In cases where you have to have both HACCP & HARPC plans, your CCP would also be a preventive control, but not automatically the other way around.

 

To me, the classic cook an egg to X temp for Y time is a good example of a step that would be both a CCP and a PC. 

 

A PC alone might be proactively monitoring your quick cool processes to avoid possible microbiological growth because current science says you have to cool your product within X time to a Y temp or face a 1/2 log increase in the microbial load.  It may not be "truly critical" (1/2 a log) and therefore you might choose to not define it as a CCP, but is something that should be overseen/monitored since the science says that you would be adding to the load and none of us should allow that to happen if we can prevent it.  By making it a PC, you would be officially aware of it and implement steps to assess contamination/risk/corrective actions, etc should product chill times go outside the established limits.  

 

I honestly think that much of the confusion is because people were already doing preventive measures (think the quick chill monitoring above).  If you are good at your job, you are looking for possible issues and seeking to prevent them.  HARPC just formalizes that process, names them something new, and possibly adds to the monitoring/verification involved. 

 

How many people had extra steps in place years ago to try and prevent allergen cross-contamination?   Well now you would formally include them into your HARPC plan and rename them as sanitation and/or allergen controls.  Same results mostly likely, new names and (more) documentation.  

 

My biggest complaint with all of this is that it just adds (more) complexity where reducing complexity improves the outcome.  

 

I now have four separate analyses (HACCP, HARPC, Defense & Fraud).  Waiting on the one to cover aliens (or would that fit under food defense?  Hmmm.... I wonder.) 

 

Not sure if I've helped anyone or just confused myself further.... 

 

Good luck,

Todd

 

 

 

 

 

[MsMars]

This ^^^ @tsebring

 

It's a good idea to keep your plans separate so that you can present your HACCP plan and only your HACCP plan to USDA and vice versa for FDA.  It may help you avoid confusion from misinterpretation in the future. 

[Charles.C]

Strange, I always thought haccp (and harpc?) Plans were based on risk assessment. Some of the material in this thread sounds more like a cookbook.

 

Maybe it's time to get back to basics.

[kfromNE]

Strange, I always thought haccp (and harpc?) Plans were based on risk assessment. Some of the material in this thread sounds more like a cookbook.

 

Maybe it's time to get back to basics.

 

From my understanding.  With HARPC, you have to list everything out - so your ingredients for example. We purchase paprika and a possible contaminant is lead oxide based upon previous adulteration data. Now based upon my analysis this isn't critical so not a CCP. However it is listed in my plan to show I considered it.

 

What tsebring is referring to is the food safety plan also know as a Food Safety Management System. The FDA took a page from GSFI and structured it more like those programs.

 

So think of HARPC as a more in depth HACCP plan. With the new FSMA/Food Safety Plan similar to what GSFI certifications require though less in depth (at least for SQF which is the only one I'm familiar with) and few risk assessments.

 

What I've done. Two binders. I've included one for the Food Safety Plan, one for SQF. In the SQF plan, I reference the Food Safety Plan when the document requirements overlap. In the Food Safety Plan, I also have included our HACCP plan as a reference which is technically in the Food Safety plan with more wording/more extensive. My food defense plan is located in the Food Safety Plan binder as well.

 

We are a smaller company so it all fits in two binders. Though I have other binders/folders with other documents that are referenced as well to avoid too much overlap and having documents located in multiple places.

[Charles.C]

From my understanding.  With HARPC, you have to list everything out - so your ingredients for example. We purchase paprika and a possible contaminant is lead oxide based upon previous adulteration data. Now based upon my analysis this isn't critical so not a CCP. However it is listed in my plan to show I considered it.

 

What tsebring is referring to is the food safety plan also know as a Food Safety Management System. The FDA took a page from GSFI and structured it more like those programs.

 

So think of HARPC as a more in depth HACCP plan. With the new FSMA/Food Safety Plan similar to what GSFI certifications require though less in depth (at least for SQF which is the only one I'm familiar with) and few risk assessments.

 

What I've done. Two binders. I've included one for the Food Safety Plan, one for SQF. In the SQF plan, I reference the Food Safety Plan when the document requirements overlap. In the Food Safety Plan, I also have included our HACCP plan as a reference which is technically in the Food Safety plan with more wording/more extensive. My food defense plan is located in the Food Safety Plan binder as well.

 

We are a smaller company so it all fits in two binders. Though I have other binders/folders with other documents that are referenced as well to avoid too much overlap and having documents located in multiple places.

 

Hi KfromLA,

 

Thks for the comments.

 

I have some sympathy for US Companies enmeshed in complying with both the FSMA/GFSI intricacies. Either one is already the stuff of nightmares IMO.

 

 HACCP was, in its original Codex/NACMCF form, intended to be logically straightforward.  I think of harpc and iso-haccp as corrupted "forks" of the original.

 

I suspect harpc  was originally launched as a political palliative to the then chorus of complaints regarding an increase in US recalls.

 

I do think that the PC approach has some useful innovations, eg focus on supply chains etc, but the project looks to have become trapped in attempts to make it haccp-convertible, or the reverse.

 

Leopards and Dinosaurs have Spots ?

[kfromNE]

This popped up in my email today - great timing. https://info.foodpro...-vs-harpc_fdsr?

[QA_123]

I just printed this.  Lets see if it confuses me even more.  lol

 

 

 

 

This popped up in my email today - great timing. https://info.foodpro...-vs-harpc_fdsr?

[LostMyMind]

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.

 

 

This popped up in my email today - great timing. https://info.foodpro...-vs-harpc_fdsr?

[QA_123]

I bought a book "HACCP combine your plan step-by-step HARPC".  I paid $90 for it.  It helped me.  But, honestly, I think I will always be at least a little unsure if not completely confused.  But, I know we go above and beyond when it comes to food safety here.  we check, check and recheck as much as possible.