Healthy CAPAs = Competitive Advantage

By now, we should all be familiar with the purpose of Corrective and Preventive Action (CAPA) as defined by the FDA Inspections guidelines:

“The purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent recurrence."

To say that CAPA is one of the most important quality system elements could be considered an understatement.

CAPA is or CAPA should be:

  • Promoting open communication among feeder systems and various departments so information can be collected, analyzed, and shared;
  • Providing a consistent risk based response to all product or quality problems identified;
  • The back bone of your quality system. Always listening, learning, and educating the other quality system elements.

21 CFR 820.100 states “Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action.” Get over it…you need CAPA. Stop fighting the requirement and make the requirement work to your organizations advantage. CAPA can be an incredibly powerful tool when used effectively. Here are several things to think about as you embrace CAPA in your organization:

Excuse me Doc, I have pain! – Risk Based

For your CAPA system to be effective, it must be consistent in the way it operates and the way it reacts to its environment. If you are in pain, you go to the doctor. The doctor reviews your symptoms and reacts providing you with a treatment regimen based on the severity of your symptoms. Much like the human body, a healthy CAPA system assesses data signals and based on the risk associated, reacts accordingly. Your quality system should be based on the risk profile of your products. Just like the doctor, the CAPA system should be able to review the risk management files for each device and react accordingly. If your CAPA system is not reacting consistently, your system will fail to react and the pain will continue.

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