CAPA generation criteria for Medical Device
Monica Deo
2 Posts


We have recently started to take an in-depth look at our CAPA system. Our QMS currently states, “a CAPA may be generated when an issue is identified to be repetitive and systemic.”

We want to be able to quantify what repetitive and systemic means in generating a CAPA or develop a criteria. We are looking to see what criteria other members have established in their organizations.

Thanks in advance,

1 Replies

@Monica Deo
Hello Monica, I would also include risk.

If things are one off or infrequent and easily corrected, with a good investigation then you could close issue without a CAPA.

The repetitive is usually 3x or more in a defined time period, again I would base on risk. If something is critical to mitigate and contain if it occurs should be the priority to keep the issue in house - again this is speaking to product processes etc. Be sure to define your effectiveness levels to show that you are in your desired control levels.

If QMS related, often the effectiveness issue maybe more training effectiveness (how do you verify?) or process (especially if change from manual to electronic system etc) be a procedural or approach issue. I would view items that are repetitive in audits (customer, regulatory, and internal) should be considered as input. Use the FDA QIST guide for management related items that can be defined as repetitive and systemic per the FDA inspection guidance document. Quality Systems | FDA

Per QIST for CAPA:

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 their recurrence. Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures. One of the most important quality system elements is the corrective and preventive action subsystem.

Also, define the repetitive and systemic during your management review so the organization can have buy in and knowledge as to why CAPAs are generated for that rationale. Prevention is the key regardless. Critical items should focus on supplemental Containment if critical, just in case scenarios - Risk Based decisions.

Good luck with the QMS and CAPA update.

Best regards,