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FDA Food Defense Plan Builder Example


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#1 Boxes

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Posted 28 July 2020 - 02:53 PM

Does anyone have a completed Food Defense Plan they are willing to share that was created with the FDA Food Defense Plan Builder? I am not finding the videos very helpful and have taken a few stabs at creating a plan with the program but felt like I may still be out in left field. Previously we had a consultant tell us we only needed to complete a Food Defense Self-Assessment on a yearly basis but recently had an auditor tell us we needed to have a documented plan and suggested the FDA program.

We produce corrugated boxes, some with direct food contact. I am sure an example from any industry may help with getting me on track with this.

 

Thanks



#2 kettlecorn

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Posted 28 July 2020 - 04:48 PM

The FDA Food Defense Plan Builder can be a pain, but it should be straightforward if you familiarize yourself with it and the FDA Guidance for Industry. 

 

https://www.fda.gov/...113684/download

 

Completed FDA Food Defense Plans should not be shared with anyone outside of authorized personal in the facility except relevant inspectors/authorities, for reasons cited below. 

 

https://www.aibinter...defense-program

7.    Food defense manuals

Customers must now verify that their suppliers are in compliance with regulatory laws and regulations as part of their supplier control programs. They also want to make sure their raw materials are being supplied by a company that has programs in place to protect products from accidental and intentional contamination. If your food defense program or manual is requested will you provide your most guarded security measures? The plant should have two versions of their food defense manual. The facility’s version will be very detailed and confidential. It will likely include private information, such as FDA registration and pin numbers, security guard requirements, and information for sensitive areas. The customer manual will be very general. 

For example, the facility version might list how many guards police the property, what they check, when they are present, when the plant is vulnerable, and the mitigation measures during these times. With the new FSMA requirements, FDA inspectors will be looking at specific areas and mitigation strategies. This could also be included in this detailed manual. In the general manual you would simply say you have a security guard program, but not provide detailed information.


Edited by kettlecorn, 28 July 2020 - 04:49 PM.


#3 kingstudruler1

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Posted 29 July 2020 - 11:03 PM

I have not used the FDA plan builder for these. I have looked at it and thought it might be easier to do myself. if you haven't already done so
I would look at some of the available training for intentional adulteration. thee link below has some free or really cheap courses that go over the rule,
key activity types, and mitigation stratagies.

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



#4 mgourley

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Posted 29 July 2020 - 11:11 PM

The Food Defense Plan Builder is a pain, but if you take the time to do it right, using FDA's Guidance for Industry for the IA Rule, there really is not much a FDA inspector can say.
 

As stated previously, Food Defense Plans are necessarily proprietary, and can not/should not be shared in a public forum.

 

Marshall



#5 Charles.C

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Posted 29 July 2020 - 11:17 PM

The Food Defense Plan Builder is a pain, but if you take the time to do it right, using FDA's Guidance for Industry for the IA Rule, there really is not much a FDA inspector can say.
 

As stated previously, Food Defense Plans are necessarily proprietary, and can not/should not be shared in a public forum.

 

Marshall

Hi Marshall,

 

As I recall, at one time, FDA used to display an example. Times are hard.


Kind Regards,

 

Charles.C


#6 mgourley

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Posted 30 July 2020 - 12:14 AM

Charles,

 

Examples are still available in the guidance documents, but what the OP asked for was a "completed" Food Defense Plan.
If I make bread and you make ham, my Food Defense Plan is not going to be of much use to you :)

 

Marshall



#7 Boxes

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Posted 30 July 2020 - 01:31 PM

Thanks for the response here. I understand how sharing a plan could be a bad thing. Seeing as in the box making industry we are not subject to FDA inspections nor do we report to the FDA. The plan builder was suggested to us during a BRC audit as the auditor vaguely remembered that it could apply to our type of business. This was in response to the completed USDA Food Defense Self-Assessment Checklist for Warehouses and Distribution Centers I had presented to fulfill the food defense requirement.

 

My biggest confusion with using the plan builder is how much detail do you go into within your processes? I'm somewhat struggling with the fact that anything is possible given the right circumstances and how do you determine whether an attack may effect a number of people being that our boxes may contain tooling, car parts, or 60 pounds of meat with potential for many servings.

 

Has anyone in the packaging industry used the FDA Defense Plan Builder?



#8 kettlecorn

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Posted 30 July 2020 - 05:11 PM

Thanks for the response here. I understand how sharing a plan could be a bad thing. Seeing as in the box making industry we are not subject to FDA inspections nor do we report to the FDA. The plan builder was suggested to us during a BRC audit as the auditor vaguely remembered that it could apply to our type of business. This was in response to the completed USDA Food Defense Self-Assessment Checklist for Warehouses and Distribution Centers I had presented to fulfill the food defense requirement.

 

My biggest confusion with using the plan builder is how much detail do you go into within your processes? I'm somewhat struggling with the fact that anything is possible given the right circumstances and how do you determine whether an attack may effect a number of people being that our boxes may contain tooling, car parts, or 60 pounds of meat with potential for many servings.

 

Has anyone in the packaging industry used the FDA Defense Plan Builder?

This will not be an adequate answer to your question about the packaging industry, but, in reference to your confusion about detail, the answer is that you should include as much detail as possible. This will include a vulnerability assessment. You need to assess vulnerable areas in the process, in the facility, in hours of the day people are working/not working, and so on. Some, or perhaps many, of the things in the FDA plan builder won't apply to your business, but many, I suspect, will. 

 

Perhaps anything is possible given the right circumstances but that is what the Food Defense Plan is meant to anticipate. What are the greatest vulnerabilities in your particular circumstance? That is where you should focus your attention. 






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