In Part 1 of this blog we discussed the first of two approaches for determining "actionable process steps." This is a facility-specific "point, step, or procedure" in a food process where there could be a significant vulnerability to intentional contamination. This "actionable process step" is the point where you would choose and apply focused mitigation strategies to reduce that vulnerability.
The first approach is to rely upon four "key activity types" determined by the FDA to have greater vulnerability. The second approach is to perform your own vulnerability assessment. Each approach has its pros and cons to consider. You will have to determine which approach to use in your food defense plan.
An alternative to relying upon the four key activity types determined by the FDA is to conduct your own facility specific vulnerability assessment. The FDA is proposing, if you choose this approach, to require that the vulnerability assessment be "performed by an individual qualified by experience and/or training."
The FDA is not proposing to specify what that particular training or experience should be to qualify one to perform a vulnerability assessment. This will be the focus of a future blog post.
Facilities choosing to perform a vulnerability assessment would be "required to employ appropriate methods... to conduct a robust and scientifically sound vulnerability assessment of the facility's food operation." Presumably the tools that the FDA has developed and made freely available to perform vulnerability assessments would be considered appropriate methods. These include the CARVER Plus Shock software tool and the Food Defense Plan Builder tool.
The main advantage for an owner selecting this approach is more tightly linking the selection of actionable process steps to their specific situation. The vulnerability assessment can take into account measures already in place that impact processing attributes like vulnerability and accessibility. Volume can be considered, such as how many servings could be contaminated by a single instance of contamination at that point (this factor is called Criticality in the CARVER acronym).
These assessments result in a relative ranking, highlighting those locations with the greatest risk of an intentional contamination that might cause "massive public health harm." By ranking all their process steps, the owner can more narrowly focus their attention (their focused mitigation measures) on only the activities where they will have the most impact.
Consider this logic argument: all top risk activities are liquid handling tanks, but not all liquid handling tanks are top risk activities.
If you extrapolate this logic to all four key activity types you may sidestep coming up with an excessive number of actionable process steps.
The disadvantage of this approach is the time and effort to conduct vulnerability assessments, and the potential need to hire an outsider to provide an individual "qualified by experience and/or training."
For any operation with a large number of process steps that are among the four key activity types, performing a vulnerability assessment might reduce the scope of your effort. For example a process with a lot of liquid transfer, handling and storage activities could focus only on those with the greatest risk.
Our previous blog article Part 1 discussed in more detail the four key activity types and how they are used to determine "actionable process steps.'" Subscribe to our FSMA blog series to be notified automatically when a new blog is posted.