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FSMA / FSVP Guidance please - What do we need to do?

FSMA UK BRC FSVP HARPC FDA

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#1 Gway

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Posted 16 January 2017 - 02:35 PM

Hi All,

 

Just looking for a little guidance as to what we need to do in relation to FSMA for foreign suppliers. We are a UK based BRC certified manufacturer of a branded product. The brand holder (our customer) wants to expand their market into the USA within the next 12 months or so. Reading on line it is about as clear as mud as to what we as the manufacturer need to have in place in order to ship the product out to the USA on their behalf - FSVP does not appear to be applicable to us as we will not be technically classed as the importer. But what I suppose I am asking is what we need above and beyond the BRC systems we currently have in place in order for us to be approvable - we of course operate HACCP, along with additional vulnerability and site security threat risk assessments as required for BRC. I have read the BRC voluntary module for FSMA which states is only applicable to US operators and most of the points made in this document appear to be wording amends to our system. Do we need to register with the FDA or be subject to additional audit?

 

Any help / guidance along the correct path will be greatly appreciated


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#2 cbb

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Posted 17 January 2017 - 10:33 PM

Hi, 

You may want to explore options for training on Preventive Controls: https://www.ifsh.iit...rols-human-food

 

If you are BRC certified and have a HACCP plan, Food Defense and Site Security, cGMPS and others prerequisite programs, Sanitation Program, Allergen Control Program, Supply Chain Control Program, Recall Plan all you need is use your HACCP plan and convert or edit it to have your Food Safety Plan =  Preventive Controls Plan.

 

FSVP is for the US Importer to meet but they may need to enforce certain matters with the exporter/ manufacturer.

 

To export to the USA you need to create a FDA registration number for your manufacturing facility here and renew it every 2 years: http://www.fda.gov/F...ion/default.htm

 

FDA can audit your facility anytime and it will be non-announced if the visit is to verify FSMA compliance.

 

See more info here including training options:

 

http://www.foodonlin...p-to-harpc-0001

 

http://www.brcglobal...px#.WH6ZHVUrKM8

 

http://ll4.workcasts...52315001001.mp4

 

http://www.brctraini...px#.WH6ZbFUrKM9

 

Trainings in Europe:

Event Date Venue FSPCA Preventive Controls for Human Food - Europe locations 07-03-2017 Birmingham - etc venues FSPCA Preventive Controls for Human Food - Europe locations 09-05-2017 London Southwark FSPCA Preventive Controls for Human Food - Europe locations 19-06-2017 London Southwark
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#3 ebb30

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Posted 27 June 2017 - 03:12 PM

I'm very late to this thread, but the company I work for is based in the USA and importing from abroad so I can tell you what we look for, if that is helpful. You may have already figured all of this out.

 

The types of foods we import are low risk (there is a kill step applied later) so we don't carry out audits, we simply require a GFSI audit certificate for every manufacturing facility (but depending on your product you may be subject to an audit from your customer). We request that our suppliers provide the address of the manufacturing location where an ingredient comes from on every CoA so that we can check and make sure we received ingredients from an approved site that we have documents for. 

 

Maybe someone can correct me if I'm wrong, but based on our risk assessment, we determined that these audit certificates are enough as they require you to comply by a lot of the same guide lines we comply with. We therefore don't require you to have a food safety plan etc. as per FSMA, we trust that the documents needed for a GFSI bench-marked certification body meets our requirements. 


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#4 Charles.C

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Posted 28 June 2017 - 03:21 AM

I'm very late to this thread, but the company I work for is based in the USA and importing from abroad so I can tell you what we look for, if that is helpful. You may have already figured all of this out.

 

The types of foods we import are low risk (there is a kill step applied later) so we don't carry out audits, we simply require a GFSI audit certificate for every manufacturing facility (but depending on your product you may be subject to an audit from your customer). We request that our suppliers provide the address of the manufacturing location where an ingredient comes from on every CoA so that we can check and make sure we received ingredients from an approved site that we have documents for. 

 

Maybe someone can correct me if I'm wrong, but based on our risk assessment, we determined that these audit certificates are enough as they require you to comply by a lot of the same guide lines we comply with. We therefore don't require you to have a food safety plan etc. as per FSMA, we trust that the documents needed for a GFSI bench-marked certification body meets our requirements. 

 

Hi ebb,

 

Thks yr input.

 

Not my area at all (fortunately) but I suspect the wave of (related?) queries popping up are mostly differing facets of this (?) -

 

http://www.ifsqn.com...vp/#entry114444

 

For this specific FSMA situation (et al ?), there appears to be a considerable degree of disarray in the "industry's" understanding of what FSMA actually wants/accepts.


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Kind Regards,

 

Charles.C


#5 dfreund

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Posted 28 June 2017 - 06:28 PM

FSVP is applicable to the US based importer to own responsibility for all hazards being controlled.  We are to hold the foreign supplier to every standard FSMA requires of the domestic suppliers.  A GFSI level certificate gets us 97% of the way and being able to document that the supplier or the importer (US) has controlled all hazards will fulfill the intent. That is the most important aspects in my operation.

 

I hope this helps.

 

DEF Safefood


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