The FDA has increased focus on the effectiveness of failure investigations during recent inspections. A review of recent 483 observations and warning letters clearly demonstrate the agency’s current concern about the adequacy of failure investigations to really identify root cause. Effective failure investigation to true root cause is the heart of the CAPA (corrective action preventive action) system.
In an effort to simplify the analysis of data, failures are often grouped into generic categories (human error, inadequate training, procedure not followed, etc.) Unfortunately investigations often stop at this point until the actual cause gets lost in this attempt at simplification. Too often a “band aid” fix is put in place (re-train, change the procedure, etc.)