Recall Management: A QMS Match Made in Heaven!
Check this out...been working on a few ideas on the concept of Recall Management
. something to the tune of 45% of all recalls are medical device
and 50% of all other recalls are food-related. That's a whopping 95% (if my math is correct). What I've learned is that recall management
is that there is a lot of activities involved to execute a successful recall - dear doctor letters, product traceability, press releases, destruction of product, and it all has to be done within 30 days.
QMS is a prime environment for handling recalls. usually the QA and RA folks are the ones who are tasked with not only executing on recalls, but also running "mock" or desktop recalls to prove the efficiency of their recall process. furthermore, many device manufacturers have a retrieval process whereby they retrieve product for marketing/repackagin purposes.
The QMS can have the document control to assign and execute on any press releases needed, the procedures necessary with escalated workflow to ensure the recall process is completed in a set amount of time, and provide traceability through a nonconformance (NCM) process, as well as the disposition.
There is a match here, methinks. I would like to see whether anyone has been thinking about using their QMS for Recall Management, or if they are using something else (perhaps ineffectively) and see the link between QMS and Recall Management...