In Reply to Parent Post by Miragesy
I'm new in Elsmar Cove. I find the site very outstanding.
I also have trouble with advisory notice procedure. Should there be a seperate procedure for advisory notices or are recall, customer complaint, post production surveillance, etc. procedures enough?
Where can I find a sample for advisory notice procedure if these are not enough?
Thank you in advance.
(In European terminology) a recall is one type of advisory notice, specifically demanding the product be returned/destroyed.
AFAIK, in the US, a recall is any type of regulatory/complaint communication.
In your QMS, you should have a cascading system:
1. Risk Management - problem prevention
2. Post Market Surveillance (not just complaints!!!!!!!)
3. Complaints Handling (sorting price complaints from safety complaints)
4. Vigilance Complaints Handling (confirmation, determination of seriousness, communication with regulators)
5. Advisory Notices (issued by manufacturer to users, advising them of product issues. Often the product does NOT need to be returned/destroyed. Usually would be copied to regulators.)
6. Recall Process (a specific advisory notice, which requires the product to be returned/destroyed. Mandatory to involve regulators when a recall occurs. An established procedure to ensure that the recall will be effective, however running dummy recalls is recommended to validate the system especially wrt communication and traceability.).
7. Risk Management - incorporating lessons learned.
There is no requirement to have more than one procedure covering these different processes. I would however strongly recommend it!