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#1 GMO

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Posted 18 January 2016 - 03:19 PM

We are an exporter to the US for single percentage points of our turnover.  I'm trying to get my head around the FSMA and I'm coming up on a few headscratchers.

 

One; is there a blooming standard anywhere; i.e. this is what we want; bang.

 

The second is HARPC.  I mean how do you even pronounce that?  If I understand this correctly, and I don't want to be rude but is it just the FDA saying "we implemented HACCP really badly so now we need to call it something else?"

 

Take this from AIB:

 

What is HARPC?

o Is it HACCP?

  1. No. It is very similar to HACCP, but it includes additional elements.

 

o Do I need to modify my HACCP plan to comply with HARPC or do I need both HACCP and HARPC?

  1. The FDA requires either HACCP (juice and seafood) or HARPC depending on product type. They do not require both.
  2. Customers and foreign governments may require a HACCP program and may not accept a HARPC program. In these cases, it may be in a company’s best interest to maintain both.

 

Erm no, I'm not implementing both...  To implement both would be to admit that the food safety system is not applied.  You can't have two food safety systems working in one factory.  Come on people!

 

So my intention is to build it in to HACCP with a few mentions to HARPC to keep FDA happy but not too many to annoy the 90+% of rest of the world governments and retailers I have to comply with.  Has anyone had any success with FDA in doing this?

 

I was thinking of including in the scope what is included in the chemical category and biological category to make it clear I'm considering parasites, toxins etc, include in the hazard analysis where applicable (to be honest it's already there); adding a radiological category (I already have a separate allergen category and have for about 8 years).  Then I was going to reference my threat and vulnerability plan for the deliberate attack.  Do I need to do any more?  Will I get a sniffy FDA auditor annoyed that I still call it HACCP?

 

Then what on earth are all the GMP requirements?  Trying to find online...


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#2 QAGB

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Posted 18 January 2016 - 04:57 PM

We are an exporter to the US for single percentage points of our turnover.  I'm trying to get my head around the FSMA and I'm coming up on a few headscratchers.

 

One; is there a blooming standard anywhere; i.e. this is what we want; bang.

 

The second is HARPC.  I mean how do you even pronounce that?  If I understand this correctly, and I don't want to be rude but is it just the FDA saying "we implemented HACCP really badly so now we need to call it something else?"

 

Take this from AIB:

 

What is HARPC?

o Is it HACCP?

  1. No. It is very similar to HACCP, but it includes additional elements.

 

o Do I need to modify my HACCP plan to comply with HARPC or do I need both HACCP and HARPC?

  1. The FDA requires either HACCP (juice and seafood) or HARPC depending on product type. They do not require both.
  2. Customers and foreign governments may require a HACCP program and may not accept a HARPC program. In these cases, it may be in a company’s best interest to maintain both.

 

Erm no, I'm not implementing both...  To implement both would be to admit that the food safety system is not applied.  You can't have two food safety systems working in one factory.  Come on people!

 

So my intention is to build it in to HACCP with a few mentions to HARPC to keep FDA happy but not too many to annoy the 90+% of rest of the world governments and retailers I have to comply with.  Has anyone had any success with FDA in doing this?

 

I was thinking of including in the scope what is included in the chemical category and biological category to make it clear I'm considering parasites, toxins etc, include in the hazard analysis where applicable (to be honest it's already there); adding a radiological category (I already have a separate allergen category and have for about 8 years).  Then I was going to reference my threat and vulnerability plan for the deliberate attack.  Do I need to do any more?  Will I get a sniffy FDA auditor annoyed that I still call it HACCP?

 

Then what on earth are all the GMP requirements?  Trying to find online...

 

 

Hi GMO,

 

I found the link below, which is actually a pretty good summary of all of the FSMA related items.

 

http://www.kelleydry...er the FSMA.pdf

 

There are some guidance docs on the FDA site, but I can't find a simple list of FSMA requirements. It is very difficult to find anything on the actual FDA website it seems. I dislike going to their website for this reason; you can't search for anything without getting 5,000 other articles about something entirely different than your actual search. When you do find thing pertaining to your reason for the visit, it's often incomplete. I have digressed a bit.

 

HARPC is pronounced Harp-Sea, and you don't necessarily need to have two entirely different documents. What I did with mine was I incorporated into my HACCP plans the radiological hazards, and hazards for food fraud (also part of BRC) and. Toxins and so forth I already had listed in my chemical analysis. I don't think the FDA will get upset as long as the plan has all of the necessary requirements.

 

QAGB


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#3 GMO

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Posted 19 January 2016 - 09:04 AM

Thank you for the link but that is 5 years old now and still isn't all that clear about what they want.  I'm working on my HACCP plan over the next few weeks but I'm still concerned there are aspects I'm simply unaware I need to be compliant with.


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#4 QAGB

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Posted 19 January 2016 - 01:13 PM

Thank you for the link but that is 5 years old now and still isn't all that clear about what they want.  I'm working on my HACCP plan over the next few weeks but I'm still concerned there are aspects I'm simply unaware I need to be compliant with.

 

Hi GMO,

 

I don't want to keep throwing links out here if they aren't what you are looking for. However, I did find another site that lists the 7 major rules in a tabbed box, and enclosed in each tab is a document with key provisions. The documents are mostly from 2014. It's pretty hard to find a detailed explanation; even more so one that's very current. I'm planning on using some of this information to ensure compliance in other areas. The link is below:

 

http://repositrak.co...ation-act-fsma/

 

 

 

I don't know that I have seen anything particularly point-by-point about FSMA. That article is about the best looking summary I have seen as far as documenting requirements (even if it is older). I remember doing a webinar a couple of years ago that was more specific. Perhaps you can find a free webinar or some sort of training that discusses FSMA more in depth.

 

Hopefully this information can at least guide you into what you will need.

 

QAGB


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#5 QAGB

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Posted 19 January 2016 - 01:31 PM

Hi GMO,
 
I don't want to keep throwing links out here if they aren't what you are looking for. However, I did find another site that lists the 7 major rules in a tabbed box, and enclosed in each tab is a document with key provisions. The documents are mostly from 2014. It's pretty hard to find a detailed explanation; even more so one that's very current. I'm planning on using some of this information to ensure compliance in other areas. The link is below:
 
http://repositrak.co...ation-act-fsma/
 
 
 
I don't know that I have seen anything particularly point-by-point about FSMA. That article is about the best looking summary I have seen as far as documenting requirements (even if it is older). I remember doing a webinar a couple of years ago that was more specific. Perhaps you can find a free webinar or some sort of training that discusses FSMA more in depth.
 
Hopefully this information can at least guide you into what you will need.
 
QAGB

 

Hi GMO,

 

One last thing: I forgot I had this AIB document from Jan 2015 entitled "What You Need to Know About FSMA". It discusses all of the rule changes, and explains a bit about HACCP and HARPC.

 

QAGBAttached File  What You Need to Know About FSMA (Jan - 2015) AIB.pdf   973.54KB   76 downloads


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#6 MWidra

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Posted 19 January 2016 - 09:16 PM

Preamble, if you are an exporter to the US, then your customers have to tell you what you need to do so THEY comply.  The onus is on the US company, not on you.  Any importer must follow the Foreign Supplier Verification Plan, which makes the company who is doing the importing responsible for verifying that the food which is being imported is safe.

 

But if you have a burning desire to have your company FSMA compliant, because you want to participate in the Voluntary Qualified Importer Program, here are some important things to know.

 

First off, unless you are one of the HUGE food companies, then you have 2 years to comply with the rule.  Exhale.

 

Second, the Human Food Preventive Controls rules were  published only a few months ago, so the guidance documents are still being written.  It will be OK, they should be out within the next few months.

 

Third, the MOST important difference between HACCP and HARPC is that HACCP is HAZARD BASED and HARPC is RISK BASED.  So the possibility of the hazard occurring needs to be part of your assessment to prevent the hazards with the highest risks.  If you include this in your HACCP plan, no one will care.

 

Fourth, the FDA does not care what you call your program, and if you want to make your HACCP plan compliant with FSMA, they will be happy with you.  But they won't be visiting you anyway, right?

 

There are many, many webinars out there to help you with the transition.  Most are excellent.  The FSMA Fridays series has been solid, and if you sign up for the series, you can access all the past webinars.  They send you an invite for each topic, and if you are not interested, you don't have to attend.  http://www.safetycha...om/fsma-fridays The meat of the webinars is usually about 45 minutes long, and you can then bug out of the sales pitch.

 

Just keep in mind that this is a US rule, and it actually makes the US companies responsible for guaranteeing the safety of the food they produce.  So they will be the ones monitoring you, based on their risk based hazard assessment.

 

GMO, chill out and have a brew.  :beer:

 

Martha


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#7 GMO

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Posted 20 January 2016 - 11:55 AM

Hi GMO,

 

One last thing: I forgot I had this AIB document from Jan 2015 entitled "What You Need to Know About FSMA". It discusses all of the rule changes, and explains a bit about HACCP and HARPC.

 

QAGBattachicon.gifWhat You Need to Know About FSMA (Jan - 2015) AIB.pdf

 

This was the document I quoted in my initial post.


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#8 GMO

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Posted 20 January 2016 - 11:57 AM

Hi GMO,

 

I don't want to keep throwing links out here if they aren't what you are looking for. However, I did find another site that lists the 7 major rules in a tabbed box, and enclosed in each tab is a document with key provisions. The documents are mostly from 2014. It's pretty hard to find a detailed explanation; even more so one that's very current. I'm planning on using some of this information to ensure compliance in other areas. The link is below:

 

http://repositrak.co...ation-act-fsma/

 

 

 

I don't know that I have seen anything particularly point-by-point about FSMA. That article is about the best looking summary I have seen as far as documenting requirements (even if it is older). I remember doing a webinar a couple of years ago that was more specific. Perhaps you can find a free webinar or some sort of training that discusses FSMA more in depth.

 

Hopefully this information can at least guide you into what you will need.

 

QAGB

 

Thanks, at least that has some enforcement dates more easily set out.


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#9 GMO

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Posted 20 January 2016 - 12:03 PM

Preamble, if you are an exporter to the US, then your customers have to tell you what you need to do so THEY comply.  The onus is on the US company, not on you.  Any importer must follow the Foreign Supplier Verification Plan, which makes the company who is doing the importing responsible for verifying that the food which is being imported is safe.

 

But if you have a burning desire to have your company FSMA compliant, because you want to participate in the Voluntary Qualified Importer Program, here are some important things to know.

 

First off, unless you are one of the HUGE food companies, then you have 2 years to comply with the rule.  Exhale.

 

Second, the Human Food Preventive Controls rules were  published only a few months ago, so the guidance documents are still being written.  It will be OK, they should be out within the next few months.

 

Third, the MOST important difference between HACCP and HARPC is that HACCP is HAZARD BASED and HARPC is RISK BASED.  So the possibility of the hazard occurring needs to be part of your assessment to prevent the hazards with the highest risks.  If you include this in your HACCP plan, no one will care.

 

Fourth, the FDA does not care what you call your program, and if you want to make your HACCP plan compliant with FSMA, they will be happy with you.  But they won't be visiting you anyway, right?

 

There are many, many webinars out there to help you with the transition.  Most are excellent.  The FSMA Fridays series has been solid, and if you sign up for the series, you can access all the past webinars.  They send you an invite for each topic, and if you are not interested, you don't have to attend.  http://www.safetycha...om/fsma-fridays The meat of the webinars is usually about 45 minutes long, and you can then bug out of the sales pitch.

 

Just keep in mind that this is a US rule, and it actually makes the US companies responsible for guaranteeing the safety of the food they produce.  So they will be the ones monitoring you, based on their risk based hazard assessment.

 

GMO, chill out and have a brew.  :beer:

 

Martha

 

Thanks but yes the FDA are auditing us in a few months time so it does apply and I want to show some willing; from what I've read, HUGE doesn't actually mean that big (what is HUGE from what you've read?) and I think would apply to me within 1 year.

 

My HACCP has always been risk based as well as hazard based and has been for some years, also a requirement of major UK retailers...

 

If I have this right, and I accept I might not, this would take my FSQMS to where it was about 5 years ago with some HACCP tweeking.  Is that fair?  I ask as well because I know there is something around pasteurisers the FDA insists on but no-one else does.  I want to make sure the little "quirks" in the system aren't missed.  It does feel a bit like to me with HARPC that the US really b*ggered up HACCP implementation so now they need a rebrand...  :shutup:


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#10 GMO

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Posted 20 January 2016 - 12:05 PM

Sorry I should have said, we are the importer.  It's not the customer, e.g. supermarket chain buying the foodstuffs as I understand it but the importer.  We also use some export agents who are about as useful as a chocolate teapot.


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#11 QAGB

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Posted 20 January 2016 - 02:08 PM

This was the document I quoted in my initial post.

 

Sorry, I didn't see any particular document referenced in the OP (I still don't), I just see AIB referenced. Hopefully, someone can help you a bit better.

 

QAGB


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#12 Anika

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Posted 04 February 2016 - 09:27 PM

Hi everyone,

 

Good to know people have started on FSMA already. I have a question and I think I know the answer but just to be sure I'm asking for opinions.

 

We are a confectionary in Canada and we export to the U.S. Our U.S sister company is a manufacturing plant as well as an importer for our products.

 

Would our Canadian company need FSVP? What about the U.S company?

 

Has there been a gap analysis or guidelines published for HARCP V.s GFSI(BRC hopefully). Seems like GFSI certified companies with HACCP are all good to go for HARCP, just slight changes.

 

Thank you!


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#13 mgourley

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Posted 05 February 2016 - 12:13 AM

I don't deal with the import/export side of things, so my knowledge is limited there.

As far as a gap analysis regarding HARPC and GFSI goes, none that I am aware of. I have seen several comparing HACCP and HARPC, though.

 

Reading Material 1

Reading Material 2

Reading Material 3

 

Everything I have heard says that if you are certified to a GFSI scheme, you are about 80% in compliance with FSMA

Two of the key things about HARPC are the requirement for a "qualified individual" to write and oversee the food safety plan, and the concept of "preventive controls".

 

In the world of HACCP, we may think of a pre-requisite as a method to control a hazard. In the world of HARPC, those programs are treated more like an oPRP or a control point, with all the requisite verification and validation to "ensure" those programs are actually controlling a hazard.

 

All this does not even address the Food Defense part of the rule that has not been finalized yet.

 

A couple of good resources are the Acheson Group which may answer some questions about import/export and you have to sign up for this from AIB.

 

Marshall


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#14 Anika

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Posted 05 February 2016 - 02:31 PM

Thank you Simon,

 

In terms of Supplier Verification, I wonder if companies(importers or exporters) need to ensure their suppliers in turn are HARPC compliant as well and this wouldn't be easy since HARPC is only for U.S but exporting to U.S would be difficult for other countries.

 

 

 

 

All this does not even address the Food Defense part of the rule that has not been finalized yet.

 

A couple of good resources are the Acheson Group which may answer some questions about import/export and you have to sign up for this from AIB.

 

Marshall

 

 

-Are you talking about the Third party Auditor Accreditation, part?

 

Thank you

 

Anika


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#15 Anika

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Posted 08 February 2016 - 07:01 PM



From the documents attached, it seems like VQIP applies for importers into the U.S like a blanket under the FSVP that will fast track food at the border and The Third Party
Certification rule passed by FDA will apply for third party auditors such as AIB or NSF I am guessing who would like to start auditing companies that wishes to be a part
of VQIP or FSVP and the auditing body in turn will need to be accredited by the FDA.
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#16 Anika

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Posted 17 March 2016 - 05:51 PM

Hi everyone,

 

an updated Q/A:http://parkcitygroup... Ready? Q&A.pdf

 

disclaimer: I do not work for reposiTrak.


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#17 Douglas NIcoll

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Posted 23 March 2016 - 07:41 PM

Official FDA training now available.

 

 

http://www.iit.edu/ifsh/alliance/pdfs/FSPCA_PC_Human_Food_Course_Participant_Manual_V1.2_Watermark.pdf


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