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PCQI vs Food Defense Coordinator

Started by , Feb 21 2020 06:06 PM
16 Replies

Hello!

 

I am the PCQI for our wholesale bakery of fewer than 500 employees in the United States.  During an AIB audit this week I was told that as of 7/26/20, for a company of our size, we need to have a certified Food Defense Coordinator.  Conveniently, AIB offers the course.  My question is: Is this true?  I have searched the internet for the term and have found little information.  PCQI isn't enough?  Is anyone aware of this training through a company other than AIB?

 

Thanks! Gwyn   

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https://www.fda.gov/...ompliance-dates and download that PDF.

July 27th has Intentional Adulteration requirements for small business.

 

Edit-

Oh and this one is new info out of FDA, I haven't even read it yet but came up in my search.

https://www.fda.gov/...al-adulteration

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Is anyone aware of this training through a company other than AIB?

 

FSPCA offers some training programs:

 

https://www.ifsh.iit...al-adulteration

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This is what FDA says:

 

Training and recordkeeping: Facilities must ensure that personnel assigned to the vulnerable areas receive appropriate training; facilities must maintain records for food defense monitoring, corrective actions, and verification activities.

 

 

I am not aware of, or heard of having a requirement for a  "Food Defense Coordinator" at your site.  Also the PCQI course does cover Food Defense. I think AIB is just trying to take your money. 

 

You should've asked them: "Show me a code, standard, regulation....etc. where it shows that we need a "Food Defense Coordinator"? 

 

Have to have a program? Yes. Training? Yes. But having a Food Defense Coordinator... not sure.. that person to my knowledge can be the PCQI. 

 

Let's see what everyone says.

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I am skimming over the guidance doc now, and I am on the same page as Food Scientist so far. I am not seeing any other requirement in the 159 page guidance document besides what was already quoted.

You do need to have a trained person who is responsible for ensuring food defense but like Food Scientist said, I don't see why that wouldn't be a role the PCQI is filling. You might want to make sure it's specifically listed in your food safety responsibilities policy if it isn't already.

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Hello!

 

I am the PCQI for our wholesale bakery of fewer than 500 employees in the United States.  During an AIB audit this week I was told that as of 7/26/20, for a company of our size, we need to have a certified Food Defense Coordinator.  Conveniently, AIB offers the course.  My question is: Is this true?  I have searched the internet for the term and have found little information.  PCQI isn't enough?  Is anyone aware of this training through a company other than AIB?

 

Thanks! Gwyn   

 

What is the authority that requires the Food Defense Coordinator to be "Certified." ?

 

All of our clients have Food Defense, Crisis, Recall, etc teams and for each one there is a "Coordinator" -- I am still looking for where an authority required that person to be "certified."

 

The pile just keeps on getting bigger.

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From an email that I got from the FDA a couple of months ago:
 
The Food Safety Preventive Controls Alliance (FSPCA) has made available another Intentional Adulteration (IA) online training course
December 16, 2019
 
A new intentional adulteration (IA) online training course has been made available, the “IA Food Defense Plan Preparation and Reanalysis” online course was developed through a partnership between FSPCA’s Intentional Adulteration Subcommittee and FDA.  The regulation requires that individuals preparing the food defense plan and performing reanalysis “have successfully completed training for the specific function at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to conduct the activities” (21 CFR 121.4©(2)). This training developed by the FSPCA is the “standardized curriculum” recognized by FDA; successfully completing this course is one way to meet this training requirement. 
 
My take is that this is something incremental above/beyond PCQI certification.  I've not personally taken the class yet.
 
Sorry to muddy the waters.  
 
Good luck.
 
 
 
 

The FDA does offer a free online Food Defense Course with certificate. This is what I have. Like Tsebring mentioned, I've tried to figure out what he quoted. I also tried to determine if the course I took would be sufficient but couldn't find the answer. From our last FDA visit in the fall - they didn't look much into our food defense program. The certificate at the time seem to be good enough.

 

In February they did release a new draft about Intentional Adulteration. I haven't read it yet so not sure what is new.

 

https://www.fda.gov/...135122/download

Your staff must undergo food defense awareness training. 

 

The FDA provides suitable training material for this.. (Food Defense Awareness Training - Free).. You can also provide your own training as long as it covers all of the important topics/ points.

 

You must also have someone in the facility that is trained in all of the following: Conducting a Vulnerability Assessment using either the KAT method or the 3-Phase method (this is a in-person course), Identification and Explanation of Mitigation Strategies and Food Defense Plan Preparation and Reanalysis. The FSPCA (who has developed these training with the FDA and are approved by them) have called individuals with whom have successfully completed all of the training "Food Defense Qualified Individuals". Instead of 1 PCQI class, they decided to break these courses up individually; more money?..

 

AIB and others have developed their OWN courses that they believe will suit the requirements of the IA RULE in FSMA (and those courses may), BUT the FSPCA course was developed with and is approved by the FDA so it WILL meet the requirements for training. 

 

See the attachment and the link for a little more information. Hopefully this helps. This all comes from the new FSMA rules (Intentional Adulteration)... 

 

https://www.ifsh.iit...al-adulteration

 

Thanks!

Attached Files

Here is how the FDA defines QI according to 21 CFR 121.3:

 

"Qualified individual means a person who has the education, training, or experience (or a combination thereof) necessary to perform an activity required under subpart C of this part, as appropriate to the individual's assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment."

 

The key there is the OR: education, training OR experience (OR a combination thereof). Nowhere does the FDA specify that a QI needs to be certified. Ryan's right the training above will fulfill what the FDA requires, but as long the Food Defense plan is written in accordance with the FDA's own Guidelines for Industry, I don't see where it's specified that an individual can't be a QI simply from, say, experience, no training (and certainly no certification) required.

 

https://www.hlfoodla...ft-Guidance.pdf

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Hi Kettlecorn, 

 

If you can prove that your qualified, then you can always go that route. Same thing with PCQI's. If you can prove your qualified, you don't NEED the PCQI training. I find it helps though. 

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One of my PCQI instructors reminded me that the "very small business" for the IA rule is sizable, so some people may be off the hook on all of this.

 

"For purposes of the IA rule, a very small business (including any subsidiaries and affiliates) is an entity that is averaging less than $10,000,000 in annual sales, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee). See the definition of “very small business” in 21 CFR 121.3."

 

And from one of the questions from one of their draft supplemental guidances (https://www.fda.gov/...135122/download)

"Can a facility that is a subsidiary meet the definition of “very small business” under part 121 even if its parent company is not a very small business? Yes. It is possible for a facility that is a subsidiary to be a very small business even if its parent company is not a very small business because not all human food sold or manufactured, processed, packed, or held without sale by the parent company is counted in a subsidiary facility’s calculation of whether it is a very small business. Specifically, a subsidiary facility only includes operations of the parent company in the calculation if the parent company is an affiliate of the subsidiary facility."

 

Anyway, I wanted to share since it might help.

 

FYI....

 

 

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There is nothing about people required to be certified.  However, I have every single employee in the company go through the FDA food defense course

 

(https://www.cfsanapp...02/FD02_000.cfm),

 

we also create our food defense program through the FDA Food Defense Plan Builder

 

(https://www.fda.gov/...se-plan-builder)

 

and I have made sure that key personnel are certified through FSPCA in Intentional Adulteration Conducting Vulnerability Assessments using Key Activity Types

 

(https://www.ifsh.iit...al-adulteration). 

 

The FDA gave some guidance on this and recommended to me that it would be required at some point and to just get ahead of it.  Hope this helps.

 

Cheers!

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Back to this topic:

 

I am actually trying to find any classroom courses for Intentional Adulteration, all seem to be online. Can anyone help?

Unless they change temporarily due to Coronavirus issues? 

Back to this topic:

 

I am actually trying to find any classroom courses for Intentional Adulteration, all seem to be online. Can anyone help?

Unless they change temporarily due to Coronavirus issues? 

I am actually enrolled in one for next month in Chicago through AIB. 

  • Food Defense Coordinator IN-PERSON, 04/15/2020-04/16/2020, Chicago, Illinois
  • FSPCA Intentional Adulteration Conducting Vulnerability Assessments IN-PERSON, 04/14/2020-04/14/2020, Chicago, Illinois

But I am thinking of cancelling.

I'm not AFRAID of COVID perse, but I also don't want to sit in an airport and be stuck on a plane with people who lick windows and don't wash their hands (ever) while a pandemic is underway.

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Greetings GMurray

 

It is indeed a fact that AIB requires for their own audit standard that someone has taken the Food Defense Coordinator training that they offer that costs over $1,000 USD for.  I should know... this happened to a place I worked at.  We dropped the AIB GMP audit and got certified FSSC 22000.

 

This training is not required for any specific food safety standard but it is required for AIB's GMP audit.

 

Have a good day,

 

Mr. I

 

Hello!

 

I am the PCQI for our wholesale bakery of fewer than 500 employees in the United States.  During an AIB audit this week I was told that as of 7/26/20, for a company of our size, we need to have a certified Food Defense Coordinator.  Conveniently, AIB offers the course.  My question is: Is this true?  I have searched the internet for the term and have found little information.  PCQI isn't enough?  Is anyone aware of this training through a company other than AIB?

 

Thanks! Gwyn   

I am actually enrolled in one for next month in Chicago through AIB. 

  • Food Defense Coordinator IN-PERSON, 04/15/2020-04/16/2020, Chicago, Illinois
  • FSPCA Intentional Adulteration Conducting Vulnerability Assessments IN-PERSON, 04/14/2020-04/14/2020, Chicago, Illinois

But I am thinking of cancelling.

I'm not AFRAID of COVID perse, but I also don't want to sit in an airport and be stuck on a plane with people who lick windows and don't wash their hands (ever) while a pandemic is underway.

 

Thanks! Luckily found one right in my city :) No need for airports !!!!!!!!! 


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