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Has anyone else undergone an unannounced FSMA Audit?

Has anyone else had one yet ?

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#1 retep

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Posted 24 May 2013 - 11:30 PM

Hello All,

 

It has been a while since my last post. I have since taken on much more responsibility. I am now the maintenance department head as well as food safety for my entire company (3 sites). I was wondering if any of you have also had an FSMA audit like I did. The inspector came in without any notice and informed me that it was going to be a 2 day audit and would last approximately 7 hours each day. Luckily my OCD organizational skills allowed me to pass the audit with only 1 minor corrective action. What I found odd was that we are a warehouse/ importer and were being auditted as a secondary processor. We basically are a box in box out operation. Has anyone had similar experiences ?


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#2 esquef

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Posted 28 May 2013 - 04:36 PM

It sounds to me like you simply had an FDA inspection. FSMA (Food Safety Modernization Act) isn't an indepent inspection / auditing body, it's a U.S. legislated act that was signed into law by President Obama with the goal of updating the FDA to be more effective at improving food safety in the U.S. largely by increasing the emphasis on preventive controls . Of the many issues that FSMA is trying to get under control is risk based FDA inspection frequency.

 

Did the inspector mention FSMA? Your facility might just have been due for a standard FDA inspection.


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#3 Oldairyman

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Posted 01 August 2013 - 02:59 PM

I am glad that the private food safety systems, are light years ahead of the FSMA . No real substance to the FSMA program .


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#4 Chris Domenico

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Posted 06 August 2013 - 05:59 PM

I am glad that the private food safety systems, are light years ahead of the FSMA . No real substance to the FSMA program .

 

What FSMA might currently lack in substance, the FDA seems to be making up for it with ambiguity. It's no secret that the full FSMA rules are years away from launch. The idea that the FDA had/has is to bring the FDA requirements in parity (and better) than GFSI so that GFSI would then have to harmonize itself with FSMA. It is a very optimistic approach and long overdue. As you said, the private food safety systems are already light years ahead and the FDA has to start putting forth some substance behind their proposed rules. :blahblah:

 

With that said, what do you think holds a greater value in the (U.S.) consumer's head - FDA approval or a GFSI certification? I'd guess that the majority of consumers in the U.S. today don't have a clue what GFSI stands for, much less BRC, SQF, IFS, or HACCP for that matter.

 

That begs another question. Forget that you have any inside knowledge of the industry. Would you purchase a food product that is stamped with a "food safety guarantee" over a similar food item that doesn't have a fancy stamp or checkmark? Should the stamp be there in the first place. or should the consumer simply EXPECT that the food he/she is purchasing won't kill them and not have to choose safety over price?

 

-Chris


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#5 Mr. Incognito

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Posted 23 August 2013 - 12:01 PM

Chris that brings up a great point.

 

I'm really amazed that the public doesn't know more about food safety at all.  Before I got into the quality world the most I knew about was ISO and that's because I worked at a DVD factory in PA.  

 

Seeing as it was the retailers that started the push for GFSI standards when recalls were bad I'd think they would have told the public what they were doing in a PSA or something to make food safer... it would only make them look better lol.

 

But in general, as with everything else, Americans don't care so long as the food makes it to their table and they don't get sick.

 

And I'm sure if there were 2 near identical products and one said "FDA Approved" and the other one said "SQF Level 3 approved" they'd buy the one that said FDA because they have no clue what SQF is and how many levels there are "Is that 3 out of 10?" lol

 

I think the Food safety standards should start doing commercials.


Edited by MerleW, 23 August 2013 - 12:03 PM.

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#6 Parkz58

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Posted 21 October 2015 - 09:22 PM

So, the question remains, now that the FSMA Final Ruling has been announced (though they still have at least 5 aspects to finalize over the next few months...go figure, that's the government for you, right?) - will GFSI certification fulfill the requirements of FSMA?  Is anyone at any of the standards (SQF, BRC, etc.) working on ensuring that FSMA requirements are addressed (either now, or in a future revision), or is this simply under their radar or outside of their scope?

 

As a company, we are looking to get SQF Level 2 certified...the bottom line question is, will that be sufficient?  Or will we have to add more to our food safety plan to appease FSMA and the FDA?

 

Brian


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#7 ChocoTiger

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Posted 21 October 2015 - 09:35 PM

Parkz58,

 

I participated in a webinar on GFSI and FSMA earlier this summer, and asked that specific question, "Is SQF Level 2 enough to cover the requirements of FSMA?".  The answer was "Yes".  SQF Level 2 provides adequate controls to align with the requirements of FSMA.  From what I understand, FSMA is HACCP (plus radiological hazards) for those food processing facilities that do not have a HACCP Plan/follow HACCP Principles yet.  As a precaution, I performed a Risk Assessment and Hazard Analysis for Radiological Hazards, and have those documents, plus a separate radiological HACCP Plan prepared if that subject comes up during a regulatory audit.


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#8 Parkz58

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Posted 21 October 2015 - 09:53 PM

Excellent - thank you so much for the clarification, ChocoTiger!!

 

Brian


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#9 ChocoTiger

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Posted 21 October 2015 - 10:05 PM

You're very welcome, Parkz58!  Holler if you need help with the radiological HACCP Plan.


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