Tag: root cause

The OOS Investigation Was Closed Without Real Root Cause

A CAPA Caselet on OOS Closure Without Scientific Root Cause Key Takeaway This caselet illustrates the critical importance of robust root cause analysis and thorough CAPA implementation in the context of Out of Specification (OOS) results. Without addressing the real…

How Poor Investigations Lead to FDA CAPA Observations

Why Weak Investigations Become CAPA Observations During FDA Inspections Key Takeaway Poor investigations lead to ineffective corrective and preventive actions (CAPA) that are susceptible to FDA observations during inspections. Addressing weaknesses in investigation processes not only improves compliance but enhances…