2 replies to this topic

[CSchmidt]

Hello,

 

I performed a Vulnerability assessment for our facility using the KAT method and the results were NO actionable process steps.  I documented in the conclusion that since no APS were identified this resulted in no mitigation strategies or management components.  

 

I feel like this isn't going to be enough for the auditors.  How do I put together a food defense plan when we have no APS?

 

 

Any help would be appreciated. 

 

 

 

P.S.  And yes I took all of the FSPCA classes and have been at our facility long enough to be a qualified individual. :)

[SHQuality]

An actionable process step is a point, step, or procedure in a food process where a significant vulnerability exists and at which mitigation strategies can be applied and are essential to significantly minimize or prevent the significant vulnerability. (21 CFR 121.3) Actionable process steps are identified during a vulnerability assessment and are facility and process-specific. (Source: FDA)

 

If no significant vulnerabilities exist, it's probably because you already have mitigation strategies in place that have proven effective.

I would list all the things you currently do (and will keep doing) that will help to keep your food defense up to standard and then review the food defense at least annually or when the access to the building is significantly changed (new doors, windows, etc)

- Do you have locks/tags on doors so non-employees can't enter without supervision?

- Do you have security cameras in place?

- Does your overall food safety plan encourage encourage employees to speak up when they see issues and people they don't know?

- Do you use a mystery guest to see how easily they can reach a food processing area in your facility?

- etc.

Edited by SHQuality, 03 March 2023 - 03:47 PM.

[kingstudruler1]

What did you do prior the current FDA rule to meet the requirement?  

 

Prior to the KATs, the FDA use to have a set of criteria that they called "Broad Mitigation Strategies" in the food defense plan builder.   I'm not sure they are still there.   

 

I'm pretty sure the attachment contains the same info.   But there may be other similar documents to evaluate "general" food defense strategies.

 

If you completed something like the attached as well as your documented KAT VA, you should be covered.  

 

(you wouldn't necessarily need to have everything in the document if a risk assessment indicates it wouldn't substantially reduce risk)

 

 

 

Attached Files

•  broad mitigation stratagies.xlsx   16.86KB   64 downloads