The purpose of a root cause investigation is to systematically analyze an event to determine the true source of the problem. If you start the investigation thinking you already know the root cause, you’re doing it wrong. Biased assumptions often lead to incorrect conclusions, making it impossible for you to pinpoint the appropriate CAPA needed.
For example, additional employee training is one of the most common corrective actions identified. But simply sending an employee back to training fails to address questions such as:
• Is the existing training program sufficient, or does it need updating?
• If the current training program is adequate, why did the mistake happen?
• Does this particular task require ongoing training due to complexity or changing conditions?
The key is to start from a blank slate without making any assumptions, so you can better pinpoint what the real problem is.
