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