Effectiveness review is a common 483 currently in the unites states. Various agencies are keying in on practices which are systemic and cause multiple failures.
Effectiveness is monitored through any/all of the following. Again this should be a system or a concerted effort, not just a once-in-a-while or after-the-fact kind of activity. Systems for assessing are required.
a) a review of a CAPA at a later date.
b) scheduled re-assessment of the CAPAs
c) trending/statistics/process control/metrics
d) review of old CAPAs when a new CAPA is initiated.
e) team of dedicated CAPA and quality engineers.
Which QRM tool is used? Many options here, and EU/FDA don’t specify which is required.
FMEA, “5 whys”, Fishbone analysis, Six Sigma analysis are some of the tools. You can also use a combination of the tools.