Non-conformance following an audit because there was open product behind an EFK unit
We had a Non-conformance following an audit because there was open product behind an EFK unit. We are a low risk manufacturing site. That was removed immediately at the time, however to close off NC I am doing a training of good manufacturing practices for open product areas. However I can't find much information online. Anyone has any guidelines or information for the topic?
Thanks
What is EFK? Open product means unpacked product or product is packed in primary pack but not in secondary pack, what exactly the situation?
EFK is electric flying killer. There were bags of heat treated seeds left open to cool before seal them.
To close the NC submit the following CAPA: 1. Reinforcement of proper procedures: Clear guidelines have been provided to ensure that all bags of heat treated seeds are sealed immediately after the cooling process. 2. Enhanced monitoring: Regular inspections will be conducted to ensure adherence to the correct handling and storage of heat treated seeds. 3. Training and awareness: Relevant staff members will undergo additional training to reinforce the importance of proper procedures and to raise awareness regarding the potential risks associated with non-compliance. 4. Review and analysis: The incident has been thoroughly reviewed to identify any underlying systemic issues. Necessary modifications to existing protocols will be made, if required, to prevent similar occurrences.
I assume the EFK was the "zapper" type, where fragments from the insects, when electrocuted, could end up in the open product.
If so, you could always replace the EFK with a "captive" variety, e.g. sticky board. We had to do this to close off a similar non-conformance for an EFK being in close proximetry to product traffic route.
In your shoes, I'd designate a specific staging area within your OPA/production area where open containers can be left for cooling. In every production environment I've seen to date, just being "in the open room" doesn't specifically mean the product is safe to be open everywhere you look. I'd go so far as to call this out in a HACCP flow chart, because leaving product alone and open in an environment presents its own risks over where it was processed and packaged.