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TAW

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Posted 27 April 2023 - 08:08 PM

Question,

 

We have a part-time employee (an older gentleman who does engineering/maintenance) and is only on site a couple of days a week.  As long as he has been with the company (as he is close with the owner), he believes that FDA regulations and company rules shouldn't apply to him, since he only works part time.

 

Today this gentleman brought his daughter with his new grandchild to meet some fellow employees after working hours but still entered the facility.  He did not get a visitor's pass or clear it with myself before entering the facility with daughter/granddaughter.  

 

If an FDA inspector happened to be on site and saw this firsthand what would be a typical response?  Warning letter?  A fine?  If a fine, how much?

 

Obviously, I can calculate the risk to the product, but in this particular situation if I wanted to show the owner that even having a friend/family member (non-employee) in the facility without first getting a visitor's pass is terrible food defense practice and illegal.  

 

I am trying to gather this informaiton to let the owner that this gentleman has to follow the rules and get it remedied.


Edited by TAW, 27 April 2023 - 08:17 PM.


Setanta

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Posted 27 April 2023 - 09:16 PM

Gosh...I think a lot would be determined by what you make. Is it RTE? Is it raw hamburger? It theoretically could show a systemic failure of your food safety plan.
Ultimately, it is the owner who needs to corral his friend.


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Scampi

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Posted 28 April 2023 - 12:58 PM

You're in a horrible spot (the kind people leave their jobs over!!!)  

 

Sometimes you cannot teach an old dog new tricks

 

If the owner took food safety seriously, she wouldn't be ok with this behavior and you wouldn't have to say anything-------see where I'm going with this?

 

It would appear one of these 2 things is all that the FDA would/could do under your circumstances

Untitled Letters

Untitled letters address violations from manufacturing controls or labeling that do not meet the threshold of regulatory significance for a Warning Letter. Untitled letters can also be issued to websites.

Warning Letters

When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter.


Please stop referring to me as Sir/sirs


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jfrey123

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Posted 28 April 2023 - 06:16 PM

I hate some of the "old dog" attitudes.  I dealt with it a lot at my first spice job, a family run company employing 9+ family members who had their names on the sign.  I was hired right as they implemented programs for their first SQF audit, and they still tried to run after the audit as if it was a 1970's warehouse instead of a 2010 GFSI certified food production facility.  Maintenance Manager drives his golf cart through the parking lot and wanted to drive it straight into production area, and sometimes he would put his cigarette out first.  Warehouse Manager carries a spit bottle on his forklift while loading/unloading trucks, because "I'm not in the production area."  Retired family wandering around the warehouse and production lines just to "see what's new."

 

In the end, they had to take some hits on their 2nd year audit that came from lack of record keeping for them to see the light.  They were used to customer audits before, audits that never really looked at things historically and they could ignore "recommendations" of, so the 2nd year SQF hitting them for not having records from the year really woke them up.  They started listening from thereon out, and by the time I left I was actually a little proud of what we had accomplished.

 

To the OP's questions:  If the maintenance guy is indeed a part time employee (of some type), I think you can get away with him not having a visitor pass.  But you'll need records of training him on GMP's and the maintenance procedures, which always drove my above mentioned family business nuts...  He'll probably argue that he doesn't need training because he's not full time, and the back and forth will continue.  As for the granddaughter, there's nothing wrong with employees giving tours, but they'd need to be signed in on the visitor's log.  Took a long time for my old company to start signing in their family members who came to share lunch in the conference room, or hang out at someone's desk for the day.  It literally took customer audits happening during these family visits for them to realize an auditor is going to see visitors and check the log for them.

 

From the FDA's perspective, warning letters are common first steps.  Do the best you can to try and manage this delicate situation, and then don't be shy about delivering the warning letter to your boss' desk if it ever comes up.



TAW

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Posted 28 April 2023 - 07:56 PM

To previous commenter, we don't make meat.  We are a small confectionery manufacturer.  The owner is pretty hands off on this sort of stuff but I sent an e-mail saying that a simple visitor's pass would've made the situation kosher.  The owner is not a big fan of SQF or regulation in general but our biggest customers would leave in an instant if we weren't GFSI certified, so I tried to explain that according to the law it is the owner of the company that bears ultimate responsibility for food safety (which he knows) and the maintenance fellow has always been a toxic person to deal with.  He was previously the head of production and the staff in the food areas threanted to quit en masse around 6-7 years ago if he were still in charge.  So he was removed from that role.  The owner believes that I was blowing it out of proportion and asked if we could get "permanent" passes for certain family members of certain employees.  I told him, "No, because then you'd be adding exceptions for certain people and that of itself would breed resentment among those who don't.  And that's a disgruntled employee situation that would create a powder keg over time putting us even closer to disaster."  Just have them check in and sign a visitor's form, it's not rocket science.



Hoosiersmoker

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Posted 09 May 2023 - 06:56 PM

I say put the old dog down... Just kidding! I dealt with that for years when I set up the FS program to begin with. Leadership / owners were all about the new business we could attract until they found out that they had to comply with all the rules too. I requested a meeting with the owners, much to their surprise, and told them I could either stop my efforts to change things and implement the system or they could help me by championing the efforts and be the solution. For the next year I met with and trained them on GMPs and their responsibilities. After that they held a strong presence on the floor and talked to all the other old timers about food safety and why it was important to implement the changes. Buy-in and support from senior management is invaluable! It made things go much smoother and consequently my life much easier. Management should never wait to be told by their Food Safety person about that issue. The proper response from them should be automatic - They know the rule and are ultimately responsible for everyone's adherence to it, you shouldn't need to bring it to their attention nor should you have to deal with the person.


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