7 replies to this topic

[SQF beginner]

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]

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)

[SQF beginner]

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

[Karenconstable]

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!

[Charles.C]

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. )

 

Hopefully Karen's input will help.

[SheenaQA&BRCGS]

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!

Hi, what if you don't know how to score the first element "potential public health impact" we don't know how many customers the products are going to. Our product is very unique and going to our sister company who then distributes them

Sent from my Pixel 4 using Tapatalk

[Karenconstable]

@Sheena,

 

If you don't have enough information to figure out the public health impact, the most conservative approach is to implement mitigation measures at all relevant process steps that are Key Activity Type (KAT) steps.

 

Remember, you only need to use the public health impact calculations if you want to justify no mitigation measures at a certain process step(s). 

 

Having said that, you should be able to calculate the volume of food at risk, since you are making it.  Page 42 of the FDA Guidance doc explains how to do that.

[Karenconstable]

Oh and you can get the FDA guidance doc on this page:  Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration | FDA