Earlier this year I had been attending a variety of local RTC and HTT meetings with a presentation designed to help people take a step-by-step approach to investigation and identifying root causes and CAPAs. I promised to publish the slides once I had completed my round of presentations, which I have now done with the slightly condensed version I presented at this year's SHOT Symposium.

Please find attached the presentation here. If you have any questions please ask them here as the answers may well be of use to other readers.

Please note, the flow diagrams are simply to help you as reporters follow my thought processes when I review reports to help identify targeted CAPA. It is not a mandatory requirement to demonstrate you've followed the processes.



SHOT Symposium.pdf