5 replies to this topic

[Bill78]

I was curious of how many of your companies have hired consultants to get ready for FSMA compliance. Based on the size of our company we don't have to fully comply until later in the year. We are BRC certified, our HARPC plan is nearly finished and I have taken the PCQI training. We've heard that the FDA inspections are pretty brutal and that many companies are using consultants to help them navigate the new FDA rulings.  Any comments? 

Thanks! 

[QAGB]

I was curious of how many of your companies have hired consultants to get ready for FSMA compliance. Based on the size of our company we don't have to fully comply until later in the year. We are BRC certified, our HARPC plan is nearly finished and I have taken the PCQI training. We've heard that the FDA inspections are pretty brutal and that many companies are using consultants to help them navigate the new FDA rulings.  Any comments? 

Thanks! 

 

 

Hi Bill,

 

I hadn't heard these inspections to be brutal yet. It's been a little bit since our last inspection, but it was probably on the level of anxiety of a customer audit. The FDA, based on what I have seen in the past, has been very observation based. I'm sure that will change some what once everyone involved is expected to be FSMA compliant. They'll likely want to see more documentation than they have in the past.

 

All I keep hearing from our 2nd party auditors (that have taken all the training and have seen other companies) is that our processes and procedures seem to fit well within the scheme of FSMA and we shouldn't have any issue with compliance. As you're BRC as well as my company, I've been told that the BRC standard pretty much covers most things in FSMA. I wouldn't say not to be concerned, but I'd say you're probably less likely to need a consultant than others out there.

 

QAGB

[Bill78]

Thanks QAGB......we had heard some stories of them taking spending a few days in facilities and doing extensive micro swabbing. Just wondered if that is consistent with what others are experiencing and hearing through the grapevine.??

[Ryan M.]

Implementation, including inspection, for FSMA is supposed to be risk-based.  So, the extent and "severity" of the FDA inspection is based on your facility and products you produce.

 

I doubt they will do any "micro swabbing", but rather pathogen swabbing.  As another person stated, it will be more document and record review than previous FDA inspections.  They will want to see your food safety plan which needs to be written in a way you show compliance with the preventive controls.  Basing your HACCP plan and calling it "HARPC" is not sufficient.  The hazard analysis is also a bit different where you look at the hazards that have a real potential to be of risk, and not just any and all hazards, and show you can control/eliminate the hazard.

 

Keep in mind the FDA inspectors are learning how to conduct the inspections to ensure facilities are complying with the new rule.  They know only a little bit more than the industry so first time inspections will likely be a shared learning experience with the facility management and the inspector.

[pablo coronel]

FSMA inspections will be a lot longer and more comprehensive than before.

What you said is consistent with what I have heard; and experienced in the LACF industry

From my short conversations with (current and past) inspectors they will visit the plants, and observe records of training, visit facilities, observe/monitor environmentals, etc

Having them on site for a day or two will not be uncommon

 

Compliance with FSMA is a long road, not only in documentation but in the culture that must permeate from the top down.
In my experience the hardest part is to get the managers to cooperate and become part of the food safety culture, 

 

Good Luck

[SQFconsultant]

Bill, in all likihood if your company is BRC and you are the PCQI and your updated plan you are very much well on your way to meeting FSMA regs.

I know that SQF did a side by side comparison on what meets or exceeds requirements and what would neef to be worked in.

It may just be a matter of doing the comparison on the BRC website and adding, enhacing items.

This you should be able to do in house without a consultant. But, if you want to cut down on time drain then a consultant would be a good alternative.

As to the inspections - I expect them to nit pick on the front end to agressive tactics and then to settle down.