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Need help with Food Defense Plan Builder

balance tank KAT APS 3 Elements Food Defense

Best Answer , 02 March 2022 - 11:33 PM

Hi, 

 

Usually, a process step that is a Key Activity Type should be considered an actionable process step. 

 

But if you want to prove/justify why such a process isn't an actionable process step, you can/should use the 3 fundamental elements method.

 

The fundamental elements process calculates a score for each of the three fundamental elements:

- public health impact,

- physical access to product and

- ability to successfully contaminate product. 

The sum of the scores is compared to the FDA's recommended vulnerability ratings.  If the score is sufficiently low, the process step can be considered to be NOT an actionable process step, one that does not require mitigation strategies.

 

Basically, if the tank is in a room that is always locked, then there will be a sufficiently low score for the element 'physical access to product' to say "We don't need (extra) mitigation strategies for this tank-holding operational step" 

 

Note: I don't use the FDA's Plan builder software, I use the FDA Guidance document, but to the best of my knowledge, the methods and concepts are exactly the same. 

 

Cheers!


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Posted 01 March 2022 - 07:32 PM

Hi guys, I'm in the process of doing the FDPB2 on our processes and became a bit confused with terminology...

Are we to use the 3 Elements score when it is a Key Activity Type and not Actionable Process Step? In this instance i'm trying to describe access to a balance tank in our process (liquid), but its in a room that is secure with locked doors.

 

Thank you for your help!



Charles.C

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Posted 02 March 2022 - 03:52 AM

Hi guys, I'm in the process of doing the FDPB2 on our processes and became a bit confused with terminology...

Are we to use the 3 Elements score when it is a Key Activity Type and not Actionable Process Step? In this instance i'm trying to describe access to a balance tank in our process (liquid), but its in a room that is secure with locked doors.

 

Thank you for your help!

HI SQFB,

 

So what in the World of Acronyms is FDPB2 ?

 

(or even 1 if it helps)


Kind Regards,

 

Charles.C


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Posted 02 March 2022 - 09:02 PM

So sorry! it is Food Defense Plan Builder 2 from the FDA website....



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Posted 02 March 2022 - 11:33 PM   Best Answer

Hi, 

 

Usually, a process step that is a Key Activity Type should be considered an actionable process step. 

 

But if you want to prove/justify why such a process isn't an actionable process step, you can/should use the 3 fundamental elements method.

 

The fundamental elements process calculates a score for each of the three fundamental elements:

- public health impact,

- physical access to product and

- ability to successfully contaminate product. 

The sum of the scores is compared to the FDA's recommended vulnerability ratings.  If the score is sufficiently low, the process step can be considered to be NOT an actionable process step, one that does not require mitigation strategies.

 

Basically, if the tank is in a room that is always locked, then there will be a sufficiently low score for the element 'physical access to product' to say "We don't need (extra) mitigation strategies for this tank-holding operational step" 

 

Note: I don't use the FDA's Plan builder software, I use the FDA Guidance document, but to the best of my knowledge, the methods and concepts are exactly the same. 

 

Cheers!


Regards,

Karen Constable

 

Food Fraud Prevention (VACCP) Programs | Food Fraud Training |

Consulting | Advisory | Compliance

The Rotten Apple Newsletter

 


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Charles.C

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Posted 03 March 2022 - 01:33 AM

So sorry! it is Food Defense Plan Builder 2 from the FDA website....

Hi SQFB,

 

Actually I should have guessed but I didn't notice the title.(It was the "2" that floored me. :smile: )

 

Hopefully Karen's input will help.


Kind Regards,

 

Charles.C






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