SQF 11.3.3.8 Jewelry Exceptions Risk Assessment

Hello,

I am having some road block in my thinking of how to handle code 11.3.3.8 of SQF Edition 9. We have a GMP policy in place which addresses jewelry and other loose objects. The last part of the code states all exceptions shall meet regulatory and customer requirements and shall be subject to a risk assessment and evidence of ongoing risk management. So, we allow plain wedding bands, headdresses, medical jewelry and face masks which would all be exceptions to our GMP policy. Can someone provide an example or template of how they handle this risk assessment? Right now, I have each exception listed out with the associated level of risk but I do not think it has enough "meat on the bone" if you will.

Thank you.

Hi Hanna,

Write what you allow into your GMP Policy, what I mean is write specifically that you allow plain wedding band, headdresses, medical jewelry and face masks (don't make them exceptions if they are approved in your policy).. Then you need to show how you determined the risk factor, handwashing (wedding band), headdress are you putting a hair net over it? How do you know that it is clean at the start of shift, this is similar to hats / ball caps. Is there a way to show that medical jewelry is clean and do you have a standard on how often a face mask needs to be replaced and or washed? I've used our monthly GMP inspection trends to validate our risk level and that the policy is followed. This also needs to account for visitors, contractors and anybody going on the production floor, I added it to a visitor sign in log. Combined all of this worked just fine for our audit. 

I'm in an extremely low risk for foreign material contamination product.  We have our risk assessment stating that the outer part of the food isn't what is eaten so the risk is essentially non existent.

the risk assessment goes on to say that our daily GMP requirements and checks will verify that jewelry etc. isn't posing a risk ---it's never been an issue

Just a note: I believe Medic Alert bracelets and necklaces are considered medical devices, not jewelry. I have found that our programs cannot exclude these due to their importance to the wearer. We request that employees opt for necklaces kept under their clothing as bracelets pose a higher risk to product as they are near the hands.

I agree with all of the above.  The only time I have had to do a risk assessment is when there was clearly something we allow that is against regulatory or customer requirements.  For example we had a warehouse that was a separate building from production.  We allowed them to not have to wear hairnets or beard nets by risk assessing it and determining it to be a very low risk based on probability and severity.  All product was fully covered when arriving at warehouse, both by individual material then an all around stretch wrap and top and bottom cover.  There was no exposed product ever in the warehouse.  The auditor agreed with the assessment.  Hope that helps.  But I agree that a plain wedding band, medical id bracelet and necklaces are not an exception to normal GMPs and given the pandemic, I would not think face masks would be either.  For the headdresses, I would answer TylerJones questions in order to understand compliance.