How to Include Adverse Events in Your Environmental Monitoring Program (EMP)

Hello,

We recently had a Food Safety Systems and GMP Audit, and one of our Non-Conformance items in regard to our EMP.

VII.C.6 For special or adverse events (roof leaks, floor drain back ups, new equipment installation or construction) must be included or captured by the EMP program.

Finding: Non-Conformance - The environmental monitoring program did not include procedures for managing adverse events such as roof leaks, drain back ups, equipment issues or other adverse events.

We address drain back ups in our GMP Policy, but it sounds like I need to move this to our EMP. As for adverse events, does anyone have any guidance on how to address this? In general, we would address the event, isolate the affected area, fix/repair the issue, clean, and, depending on the event and severity, take a few sample swabs to be tested.

Thoughts? Should this policy be more specific?

I think they just want you to say that in those types of events you will conduct extra environmental samples to ensure the event didn't contaminate your production area with microbes that your normal plans wouldn't account for.   

Salmonella is an under recognized contaminate from bird poop on roofs that drips into the plant via a roof leak.  So in the event of a roof leak, there should be some sort of risk evaluation done, with monitoring until fixed, a plan for a final clean up/Sanitization, and the verification that the area is clean.  

You may also want to add a Crisis Management Procedure, one place where you can add details to what the business will do in those kind of events

This should be done collectively across departments---then the guess work is gone and you have a path through

It's also a GFSI requirement to have

You may also want to add a Crisis Management Procedure, one place where you can add details to what the business will do in those kind of events

We do have a Crisis Management Procedure in place, although it does not address Environmental Monitoring.

My initial plan for corrective action will be to add a section in our EMP to address this for our recent audit, since it is specifically called out in the finding. However, we are also in the process of converting our Food Safety Plan to SQF, and it might make more sense to add this to our Crisis Management Procedure.

If you want to mention it in EMP, it should be a brief statement that refers your staff to the Crisis Management program.  The Crisis Management program, listing out the different potential disasters and your approved approach to handling them, should have different EMP requirements depending on the disaster type.

Doing environmental swabbing due to an adverse event is different given the event:  for a roof leak, I'm absolutely isolating the area and doing some swabs during and after the repair, along with increased sanitation frequencies; but if a tornado rips the roof off the building, I'm not going to worry about swabs for a while.

If you don't already have a vector sampling in place in the chance that you have a positive hit in your EMP I would add this as well. 

If you capture adverse food safety events in your Crisis Management Program then these 2 programs would then tie in together.  I have in the Crisis Management Program food safety and damage assessments that are conducted with the food safety team, including environmental impacts, product assessments, facility, equipment, etc. 

Outside of the general routine monitoring in the EMP (which is what this program is designed for) you can reference the Crisis Management Program for anything related to adverse events.  

I think this is all valid, I'd also add that I do and have uplifted environmental monitoring during planned works.  The reason for this being that while we put controls in place, screening etc, it is an additional check (and forces one of the quality team to go and check standards while they're there which I'm bothered about more!)  But the other benefit is if you do have an issue later, you can use whole genome sequencing or similar to link the issues.

But, off topic slightly, can we just pause and recognise that a regulator is asking us to have improved monitoring when a roof leaks or drain backs up.  While it's all good practice and I'm not saying you shouldn't, doesn't it speak to a certain acceptance?

All great feedback! Thank you to everyone who has answered!

But, off topic slightly, can we just pause and recognise that a regulator is asking us to have improved monitoring when a roof leaks or drain backs up.  While it's all good practice and I'm not saying you shouldn't, doesn't it speak to a certain acceptance?

I should have mentioned in my original post that this was a third party audit, not a government inspection. But you are correct, aside from this finding, the auditor accepted our EMP. In years prior, we've received full points on this because we verbally explain that we will increase testing in the event of an adverse event. However, it goes to show that we need to make sure we address this in our written plan.