Risk Based Quality Systems Audits for Medical Devices and Drug Prodcuts
Wayner Williams 3865
Joined 10/13/2018 - 2 Posts
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
Girish Trehan 4879
Joined 12/17/2018 - 5 Posts
Hi Wayner,

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

Best, Girish 
Rajesh Babu 5656
Joined 01/28/2019 - 6 Posts
FMEA .. its simple to follow and there is provision for constant review and re evaluation of risks 
Lisa Shinholster 7310
Joined 05/07/2019 - 1 Posts
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.


Douglas Wood 2075
Joined 06/30/2018 - 15 Posts
I am offering a webinar on this in May. Attached is a secure pdf file with more information. Webinar Aplomet RBQA 20200409.pdf