4 replies to this topic

[ColbyHolstein]

Hi All,

 

I apologize if this is already a thread and I haven't seen it, but I was hoping to get some advice on a quality food defense monitoring strategy. 

 

As part of our vulnerability assessment, we've identified a step where restricting access to the process to authorized personnel seems to be the best mitigation strategy. Employees that should be in the room wear blue uniforms and it would be very suspicious if other employees were in the room.. few people have reason to be there.

 

What would be a good monitoring component for this and further what would you recommend for verification? I was thinking of exception monitoring, because like I said most of the time (the whole time I've been here) only the appropriate personnel are in there doing their job. But what would exception monitoring look like? Corrective actions for when people need to be removed from the room? And what would verification look like? Should I just walk by and verify that only authorized personnel are in the room or would it be better to have someone from a different department go into the room and see if anyone questions them being there?

 

Or maybe I should use a different monitoring style altogether.

 

Too bad the FDA guidance on the IA rule is incomplete for now.

 

Thanks for any comments, they are much appreciated and welcomed,

 

C. Holstein

[Fishlady]

FDA specifically says that it is acceptable to use forms that were created for other purposes for documentation regarding food defense measures.  Do you already have a form where someone is monitoring that everyone in the area is wearing the correct outer garments (perhaps as part of your GMP monitoring)?  If so, you can use that as monitoring for the food defense measure as well. Make sure that you are regularly reviewing the monitoring forms- and yes, it is good to do that check yourself periodically and/or directly observe the person who does the check.

 

Have your employees been trained to report when they see someone in their areas who does not belong there?  You can verify it by asking someone to enter the area without the correct outer garments, as you suggest. Interestingly, in the facility I was working in, our employees were very quick to challenge anyone they didn't know.  Yet, when I performed an internal audit at our sister facility, where I was allowed to roam the production area unaccompanied, wearing gear that identified me as a visitor (I had been there a few times before but only knew a handful of people), it was about 45 minutes before someone finally came up and asked if I needed help. I congratulated him on being the only one to do so and also informed the QA Manager that the crew needs to up their game.

[Charles.C]

Hi All,

 

I apologize if this is already a thread and I haven't seen it, but I was hoping to get some advice on a quality food defense monitoring strategy. 

 

As part of our vulnerability assessment, we've identified a step where restricting access to the process to authorized personnel seems to be the best mitigation strategy. Employees that should be in the room wear blue uniforms and it would be very suspicious if other employees were in the room.. few people have reason to be there.

 

What would be a good monitoring component for this and further what would you recommend for verification? I was thinking of exception monitoring, because like I said most of the time (the whole time I've been here) only the appropriate personnel are in there doing their job. But what would exception monitoring look like? Corrective actions for when people need to be removed from the room? And what would verification look like? Should I just walk by and verify that only authorized personnel are in the room or would it be better to have someone from a different department go into the room and see if anyone questions them being there?

 

Or maybe I should use a different monitoring style altogether.

 

Too bad the FDA guidance on the IA rule is incomplete for now.

 

Thanks for any comments, they are much appreciated and welcomed,

 

C. Holstein

Hi CH,

 

Is there a GFSI-recognized Standard  involved or is this just FSMA  ?

( I anticipate the latter since afaik nobody else calls VA = Food Defence)

[jfrey123]

Just a couple thoughts on what I might try (as you say, the guidance is up in the air):

 

-Separate training for supervisors/managers in the higher risk area to note and remove unauthorized employees.  All employees should have training to challenge unauthorized persons, but now sups and mgrs in those areas need to know to reject unauthorized employees as well.  If they've got forms the record daily production information into, or even your company's standard deviation reports, those could be utilized and turned in to report occurrences.  Then you trend it along with your other deviation information.  I think this is something production can and should be in charge of enforcing.

 

-A spot check by QA could be useful, but how often would you want to do that?  Whole new form and recording system?  I'd think a quarterly challenge by QA personnel would be more effective, having someone from QA wear the wrong uniform into the area and see how long they last before getting challenged and writing that up for review when you audit your Food Defense Program.

 

-Controlled access points may help reduce the risk.  If this area has doors that you could consider installing keypad or card locks onto, that would go a long way towards securing access.  If forklifts need to get into this room, I know they make sensors that could tie into door controls so only approved operators or machines go into that area, etc.

[ColbyHolstein]

Thanks for the responses and the advice. I like the use of GMP documents to monitor if unauthorized personnel are present and additional training for supervisors and managers.