17 replies to this topic

[fdpujol]

Hi

Does anyone know when HARCP plans will be required during SQF audits ?

Thank you

Francois

[CaliforniaFS]

Are you talking about the FDA requirement of HARPC?

If so, it is required to be implemented by September of this year.

 

Thanks,

 

Cal

[fdpujol]

Yes thank you.

I supposed this will be part of SQF accreditation audits from September 2106 ?

[esquef]

HARPC is the Food Safety Plan for FDA FSMA (Preventive Controls for Human Food) and essentially replaces CCPs with hazard analyses and preventive controls. This is a U.S. FDA requirement for food processors in the U.S. andalso has implications for importation of food into the U.S. from exporting countries.

Since SQF is global, they look for your Food Safety Plan to be HACCP based.

It is possible (and most likely beneficial) to modify your existing HACCP plan(s) to be acceptable for HARPC inaddition to HACCP guidelines. I just got back from a 2 1/2 day training conducted by FSPCA (Preventive Controls for Human Food). They developed their training in concert with FDA. I'd recommend attending a training class on the subject in order to stay current with U.S. regulations re. FSMA.

[Charles.C]

HARPC is the Food Safety Plan for FDA FSMA (Preventive Controls for Human Food) and essentially replaces CCPs with hazard analyses and preventive controls. This is a U.S. FDA requirement for food processors in the U.S. andalso has implications for importation of food into the U.S. from exporting countries.

Since SQF is global, they look for your Food Safety Plan to be HACCP based.

It is possible (and most likely beneficial) to modify your existing HACCP plan(s) to be acceptable for HARPC inaddition to HACCP guidelines. I just got back from a 2 1/2 day training conducted by FSPCA (Preventive Controls for Human Food). They developed their training in concert with FDA. I'd recommend attending a training class on the subject in order to stay current with U.S. regulations re. FSMA.

 

Hi esquef,

 

Will SQF not be obliged to implement a change in their Standard for US/FDA regulated  facilities / auditees since in such cases HACCP will presumably become "illegal" in USA ?

[CaliforniaFS]

I plan on having both plans.

I'll be attending a class as well.

Here is a link with more information comparing the HACCP and HARCP.

 

https://www.scsgloba..._fact_sheet.pdf

[RMAV]

SQF Code 7.2: 2.4.1.1 Food Legislation (Regulation): "The organization shall ensure that, at the time of delivery to its customer, the food supplied shall comply with the legislation that applies to the food and its production in the country of its origin and destination."

 

If you're not yet subject to HARPC, you don't get dinged in your SQF Audit (Small businesses have until September 2017 to implement). 

 

Charles C.: "Will SQF not be obliged to implement a change in their Standard for US/FDA regulated  facilities / auditees since in such cases HACCP will presumably become "illegal" in USA ?"

 

It's an interesting implication, isn't it?  Note, though, FSIS-inspected facilities will still operate under HACCP as you know.  Also for the FDA side one of the exemptions is those falling under Juice HACCP.  So we'll still have HACCP here in the U.S.  But as SQF 7.2 reads, we'll need a HARPC and a HACCP plan for the non-exempt products (FDA won't care if we still have a HACCP plan on the side so long as we have the "HARPC" plan).  I am guessing SQF 8 is going to solve that issue.

[mgourley]

Hey, don't worry. FDA has said they will have ample guidance documents. They just do not have a timeframe when they will be available.

I'm not SQF, but BRC has fairly similar language when it comes to "legislation". So in theory, and how much of a stickler your auditor is, Yes...you will have to have a Food Safety Plan that meets the FDA requirements (if you fall under that legislation).

 

But, as RMAV points out, I think the vast majority of people here probably fall under the "Small Business" entity that FDA has decided upon. So you still have well over a year to become compliant.

 

Marshall

[mgourley]

Charles, as RMAV alludes to, HACCP will not become illegal is the US. There are plenty of carve outs where FSMA will not apply, especially in the case of Juice and Seafood HACCP, which are already "regulatory HACCP".

 

Marshall

[Charles.C]

Charles, as RMAV alludes to, HACCP will not become illegal is the US. There are plenty of carve outs where FSMA will not apply, especially in the the case of Juice and Seafood HACCP, which are already "regulatory HACCP".

 

Marshall

 

Hi Marshall,

 

Yes i realized there are a few like you mention but i seem to recall seeing a publication mention this only applies to a very few "industries" ? Bakeries ?

 

I think i noticed a comment somewhere that BRC are already preparing a harpc compatible version ?

 

I guess BRC will be unable to enforce anything until the list of HRisk Ingredients comes out .

 

PS - sorry that i have no idea as to the scope of Small Businesses.

 

PPS - A lot of meat people must surely be thinking - How lucky can one get ?

[mgourley]

And meat people find it odd that anyone should have a metal detector.

 

Marshall

[Charles.C]

Hi Marshall,

 

And similarly for Seafood until the first nuts and bolts turn up. Seeing is believing.

 

I find it ironic that the FDA championed the introduction of routine HACCP via their pioneering Seafood work leading to the masterpiece "Final Rule" ca. 1995.

 

Now they seem to be dumping  the basic CCP/GMP/PRP concepts of all that work so as to achieve a level playing field. Or is it Politics ? Never say Final.

 

I am anticipating a strong push-back from the Fresh Produce sector when the "H(it)-List" appears.

[esquef]

"Hi esquef,

Will SQF not be obliged to implement a change in their Standard for US/FDA regulated facilities / auditees since in such cases HACCP will presumably become "illegal" in USA ?"

Charles,
As mentioned above HACCP will not become "illegal" under HARPC; in fact HACCP is indeed a part of HARPC. The principal steps break down similarly

PRINCIPAL HACCP HARPC

1 Hazard Analysis Hazard Analysis (a written hazard analysis is required for all products or product families which identify hazards requiring a preventive control)*
2 Critical Control Point Preventive Controls**
3 Critical Limit Critical Limit (in a food process)
4 Monitoring Monitoring
6 Corrective Actions Corrective Actions
7 Verification Verification / Validations
8 Record Keeping Record Keeping

*The hazard analysis process identifies potential hazards, evaluates likelihood and severity of these potential hazards it identify those which require a preventive control, and identifies process, allergen, sanitation, supply chain or other PCs for potential hazards
**Preventive controls are defined by FDA as "Those risk-based, reasonably appropriate procedures, practices and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of foods would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manucturing, processing, packaging or holding at the time of the analysis" (FDA 21 CFR 117.3 Definitions)

Preventive controls may include process PCs, food allergen PCs, Sanitation PCs, Supply Chain PCs, Recall Plan, etc.

So, the two Food Safety Plans are not as different as one might think; I see HARPC as a ramped up version of HACCP.

[Charles.C]

So, the two Food Safety Plans are not as different as one might think; I see HARPC as a ramped up version of HACCP.

 

Hi esquef,

 

You might be interested to have a look at a few HACCP Plans ca.1990s, especially those  which focussed on CCP1 and CCP2

 

I suggest that FDA have succeeded in re-inventing the square wheel.

[esquef]

No arguments from me Charles. The "ramped up" part (IMO) would include validations for a few items that HACCP doesn't explicitly require, most prominently the supply chain (including Foreign Supplier Verification). And like you mentioned there's no such thing as a "Final Rule". FSMA will be in a state of flux for at least 10 years due to the complexity of building a regulatory food safety plan in a constantly changing global food processing, manufacturing, packaging, and transport environment. That and the fact that the U.S. can't afford to fund FDA to effectively implement FSMA in a timely fashion. ;>)

[Antores]

I see there is a lot of confusion here, but Mr. RMAV got the point.

All GFSi audit have a requirement for the operation to comply with the local legislation of the country of origin or destination.  So based on this, SQF or any other GFSi standard won't even have to modify or add a mandatory requirement for HARPC, especially because these are GLOBAL standards, and HARPC applies only to the USA and only to SOME food operations. 

So, if your operation follows under the FSMA Preventative Control Rules, you must be in compliance by the dateline established by the FDA (it varies depending on the operation size), and your GFSi auditor technically should verify that you are following HARPC principles.

By the way, please don’t say HACCP will be Illegal.  HARPC is not required for all “food processing”, and one exception is those facilities that are already required to have a HACCP program, that includes Juices, Dairy, and Fish. If you are doing any of these, you must still use HACCP, so HACCP is far from “illegal’

Finally, “HACCP” and “HARPC” are not very different or “exclusive”, If you have a HACCP Plan, and your operation falls under the Preventative Control Rule, you can just modify your program and actually still cover both, and call it HACCP and HARPC program if you want.

So if your GFSi audit requires you to have HACCP, and you are under the HARPC, you can still have your HACCP program and add the HARPC requirements.  You will simply add risk analysis for Food Allergen, Sanitation, and Supply-Chain (risk analysis for processes are already covered in HACCP), and will add the necessary “Preventative Controls” on top of the CCP’s you already have.
Hope that helps

[Charles.C]

I see there is a lot of confusion here, but Mr. RMAV got the point.

All GFSi audit have a requirement for the operation to comply with the local legislation of the country of origin or destination.  So based on this, SQF or any other GFSi standard won't even have to modify or add a mandatory requirement for HARPC, especially because these are GLOBAL standards, and HARPC applies only to the USA and only to SOME food operations. 

So, if your operation follows under the FSMA Preventative Control Rules, you must be in compliance by the dateline established by the FDA (it varies depending on the operation size), and your GFSi auditor technically should verify that you are following HARPC principles.

All Food Standards require the user to comply with Local legislation. Presumably including Importers to the USA.

By the way, please don’t say HACCP will be Illegal.  HARPC is not required for all “food processing”, and one exception is those facilities that are already required to have a HACCP program, that includes Juices, Dairy, and Fish. If you are doing any of these, you must still use HACCP, so HACCP is far from “illegal’

Please note the apostrophes.

Finally, “HACCP” and “HARPC” are not very different or “exclusive”, If you have a HACCP Plan, and your operation falls under the Preventative Control Rule, you can just modify your program and actually still cover both, and call it HACCP and HARPC program if you want.

HARPC represents a basic change from both Codex and NACMCF.

So if your GFSi audit requires you to have HACCP, and you are under the HARPC, you can still have your HACCP program and add the HARPC requirements.  You will simply add risk analysis for Food Allergen, Sanitation, and Supply-Chain (risk analysis for processes are already covered in HACCP), and will add the necessary “Preventative Controls” on top of the CCP’s you already have.
Hope that helps

 

Hi Antores,

 

No offence intended but i do believe you are over-simplifying the situation.

[Charles.C]

Hi Antores,

 

Just to illustrate my understanding of the current  HARPC scenario, can see this link -

 

http://safefood360.c...accp-and-harpc/

 

Of course some things may yet change before the "deadlines" so as to support your opinion.