Risk Based Quality Systems Audits for Medical Devices and Drug Prodcuts
Greetings ASQ Members,

Would anyone have suggestions on tools/tips for developing a risk based approach to medical device and drug product internal quality system audits?  I'm looking to develop a risk based approach for determining the scope (i.e. products, processes, systems etc. reviewed) as well as the frequency.  Not sure if there are generic tools for risk ranking -as an example - that are being used.

Thanks - Wayner 
4 Replies
Hi Wayner,

The Aspect Failure Mode Effect Analysis, a FMEA based tool can be used for risk based implementation.

Best, Girish 
FMEA .. its simple to follow and there is provision for constant review and re evaluation of risks 
Good afternoon;

A great resource you may want to consider is Barry Craner.  I had the honor of participating in the Risk Management: Tools & Audits for all Trades; one of the Pre-Conference workshops at the Annual ASQ Audit Division Conference in Orlando, FL on Tuesday - Wednesday of this week.  He has a depth of knowledge of this subject for the Medical Devices industry.


I am offering a webinar on this in May. Attached is a secure pdf file with more information. Webinar Aplomet RBQA 20200409.pdf