Which description best defines preventive actions in CAPA?

• A. Actions addressing root cause to prevent recurrence
• B. Actions addressing potential issues before they occur
• C. Actions to correct a deviation after it occurs
• D. Actions to document training records

Answer: (B)

Preventive actions in CAPA are about stopping problems before they happen. They are proactive steps taken to reduce the chance that a potential issue will occur, based on risk analysis, trend data, or process weaknesses identified ahead of time. This can include updating procedures, adding controls, changing designs, improving training, or tightening supplier qualifications to head off failures before they impact quality or safety.

What this means in practice is that preventive actions target future events and aim to avert them, rather than reacting after something goes wrong. In contrast, actions that address the root cause to prevent recurrence are corrective, because they respond to an issue that has already occurred to stop it from happening again. Actions to correct a deviation after it occurs are also corrective, focusing on fixing the problem after the fact. Documenting training records is an administrative step and doesn’t inherently prevent a future problem by itself.