Show whether a corrective action actually worked

Repeated field signals justify an investigation and a decision about corrective action.

A CAPA assessment with predeclared effectiveness criteria and observed results or an open monitoring period.

Corrective action and effectiveness

Distinguish immediate correction, investigation, corrective action and evidence of effectiveness.

Choose an effectiveness criterion that could falsify the proposed conclusion.

Engineering and product leaders; basic development knowledge, Ketryx knowledge taught as needed

8–12 min