GMP Enforcement when employee has medical note for smart watch wearing
We now have two employees providing a doctor's note stating they need to wear their smart watch in order to monitor their heart rate. One employee is in packaging and the other is in quality. As an SQF pet food manufacturer this going against multiple policies and procedures. Has anyone come up against this? How have you handled it at your facility. Any ideas or suggestions? Thank you!
This is straight from module 11.3.3.8:
Jewelry and other loose objects shall not be worn or taken into a food handling or processing operation or into any area where food is exposed. Wearing plain bands with no stones, prescribed medical alert bracelets, or jewelry accepted for religious or cultural reasons can be permitted, provided these items are properly covered and do not pose a food safety risk.
All exceptions shall meet regulatory and customer requirements and shall be subject to a risk assessment and evidence of ongoing risk management.
If a doctors note has been provided, then I would create an exceptions log to document the risk associated and list who this applies to. Also a daily check that these smart watches are in good condition and pose no risk outside of the general risk assessment applied.
I haven't personally had to deal with a smart watch siltation, more along the lines of a medical alert necklace and religious bracelets, and this is the path we took.
All the best!
If this were my place, I'd tell them to find another way to monitor their heart if they want to work in my production area. They make things that strap around your chest, which would be covered by a shirt obviously. They are like twenty bucks. They could either get something like that, or get a move on outta my building. Smart watches have a glass face. No go.
Not knowing their condition, I must say it sounds like BS to me. There's not a doctor I'm aware of that would ever monitor a heartbeart via a smart watch. Regardless, you'll know really quick when you give them this option. If they don't take that option, it has nothing to do with monitoring their heartbeat....
Really surprised a legitimate doctor wrote a legitimate note for a smart watch, as I'm not aware of any consumer grade smart watch being a qualified medical device:
Fitbit and Apple know their smartwatches aren't medical devices. But do you? - CNET
That said, code is code and it's a stretch to call them medical bracelets since the bracelets are referring to those simple metal once that can be washed and metal detected.
I think both employees should be moved to a position where they aren't around exposed food. That would solve the code conflict. If the doctors' notes are legitimate, employers have an obligation to make reasonable accommodations around the medical condition. If you want to keep them there, you're going to have to write up a risk assessment that might cover them wearing gloves and a full sleeve smock to completely cover the watch with a periodic inspection by a supervisor that the watch is clean and unbroken. Tough spot to be in for sure...
Our Food handlers must understand and prioritize hygiene and food safety. Ensure that the smart watches worn by food handlers are appropriately covered to avoid any direct contact with food or food preparation surfaces. Provide thorough training to the food handlers on maintaining hygiene and preventing cross-contamination, emphasizing the importance of adhering to our existing food safety protocols. If found in violation of food safety guidelines, then do not hesitate to take the disciplinary action.
I would have the employees fill out some sort of form listing the type of smart watch, which wrist they wear it on, what their typical job duties/locations are. You may want to require them to have a shatter-proof cover for the screen, since it's glass. It may be good to keep a copy of the forms with your glass items registry, as well.
You could have their immediate supervisor inspect the watch daily to ensure that the screen is intact, as well as the straps, as fabric straps can fray. You could require that they use metal straps made of metal-detectable material, as well. I would also add that if a regular glove does not cover the watch, they must wear plastic sleeves for sanitary purpose.
I wouldn't question the medical validity, since doing so can lead down a tricky legal path and that should be HR's job to handle. You may want to speak with HR about "reasonable accommodation" and if that trumps your company's food safety policy/ability to produce safe food. HR may be able to suggest to the employees that they find an alternative method of monitoring their heart rate, as some suggested above. It would also be wise to work with HR to establish a formal policy regarding smart watches used for health monitoring and what is allowed vs. what is not allowed.
I had the same situation with and employee that brought us a note stating they needed to wear the smartwatch at all times. I told the employee to take it off, that we would not allow it and to call their doctor for an alternative or they would have to end their employment with us. I asked them the next day and they said they couldn't get in touch with the doctor. Same answer for the next week. I stopped asking, they never wore the watch at work again and I never heard about it again.
It is my understanding that medic alert necklaces and bracelets are considered medical devices and therefore not technically jewelry but only the necklace is allowed here.