Undefined Root Cause Analysis in SOPs: A Major Deviation Risk
Undefined Root Cause Analysis in SOPs: A Major Deviation Risk Why SOPs Must Define Root Cause Analysis Processes in GMP Systems Introduction to the Audit Finding 1. Nature of the Finding When SOPs related to deviation handling, OOS, or complaint investigations lack a defined root cause analysis (RCA) method, investigations become inconsistent and unreliable. 2….
Read More “Undefined Root Cause Analysis in SOPs: A Major Deviation Risk” »