Effective CAPA Plan Management: Timelines, Root Cause Analysis, and Corrective Actions

Each Notified Body has their own timelines for delivering CAPA plans, but most of them are already in line and the first CAPA plan must be delivered within 30 days after the audit closes. 

A nice development for manufacturers is that there is now also a timeline for Notified Body review of the CAPA plan. 

The limitation of 3 rounds/90 days to submit an acceptable CAPA will impact initial clients. The delivery of a high-quality CAPA plan is even more critical. 

A corrective action plan documents the investigation and actions taken to resolve a non-conformity, beginning with root cause analysis. This can be performed using any effective methodology to determine the underlying reasons for the non-conformity. 

Root cause analysis can be done in various ways. A smart reviewer should use the best methodology and involve specialists to investigate each non-conformity, considering its impact on the Quality Management System. Lack of knowledge may not be the sole cause. Often, multiple factors contribute to the root cause, and if not properly identified, the non-conformity could recur. Inadequate root cause identification can lead to wasted time and resources, adding costs to the company. 

After root cause analysis, you should identify corrections and corrective actions. A common mistake is to treat corrections as corrective actions, but they are different. 

• A correction is an action to eliminate a detected non-conformity.
• A corrective action addresses the root cause of the non-conformity. 
  
  

A correction fixes the immediate issue, but doesn’t address the cause or prevent recurrence. If multiple errors require correction, corrective action may be needed to resolve the underlying cause. Both corrections and corrective actions must be implemented, along with verification of their effectiveness (VoE). 

In CAPA handling, inadequate investigation and root cause analysis are common. The goal is not just to solve the surface issue, but to thoroughly review and identify the root cause, correction(s), corrective action(s), and VoE(s). 

The plan, including root cause analysis, corrections, corrective actions, and VoE(s), must be reviewed by the audit team and resolved within the given timelines to maintain certification. CAPA teams should remain aware of timelines when defining deadlines and follow available guidance to resolve non-conformities on time and avoid challenges to certification. 

You can also refer to MDCG 2024-12 related to CAPA plans. Though officially for Notified Bodies, the method is the same for manufacturers.