What Drives the Bus?
After reviewing many CAPA SOP’s there appears to be two primary directions companies go in to decide if they are going to initiate a CAPA:
1. An issue (nonconformance ect.) is identified and a root cause investigation is conducted. Based on the the investigation a decision is made to address the issue as a CAPA or not.
2. CAPA is initiated (based on risk) and the first action is to conduct a root cause investigation.
Based on your companies current flow process, which comes first; initiation of a CAPA or a root cause investigation?
Tags: capa, corrective action, investigation, preventive action, root cause, root cause analysis
