CAPA Data Sources; What Makes a Compliant CAPA System

Q: My question is about what makes a compliant CAPA system, including appropriate CAPA data sources. We recently received a 483 notice citing inadequacies in our CAPA system. Could you review for me FDA’s basic requirements for CAPA?

Moreover, what are the most important sources of quality data we should feed into our CAPA system? And what criteria should we use to decide when to elevate a nonconformance to a CAPA?

A: FDA’s minimum requirements for a CAPA system are that you must first identify your CAPA data sources (the sources of quality data), document and evaluate all nonconformances, and investigate those nonconformances to their root cause when needed.

Then you must identify and implement corrective and preventive actions, ensure the effectiveness of your actions, and always track and trend your quality data.

The top CAPA data sources you should feed into your CAPA system include:

  • Nonconformances
  • Complaints
  • Incoming, in-process, and finished product testing
  • Internal audits as well as audits of suppliers
  • Equipment performance data
  • Calibration and maintenance data
  • Environmental and process monitoring

For criteria to decide when to elevate a nonconformance to a CAPA, here’s what I recommend to my clients:

For most products or processes, elevate anything that occurs beyond its expected frequency or severity — or anything that happens in an unexpected manner.

Furthermore, for a product nonconformance, elevate anything that may have caused or contributed to a death, serious injury or illness.

Be sure to document all of your CAPA actions and decisions. Incorporate your design and process risk documentation to help you make better decisions whether or not to open a CAPA.

Also, be sure to refer back to the results of your previous investigations — they will help you better understand different failure modes, both in your product design and in your post-market activities.

Answered by Denise Dion, Vice President of Regulatory and Quality Services for EduQuest, who served 18 years at the U.S. FDA as an expert field investigator, where she also helped to develop FDA’s Quality System Inspection Technique (QSIT). Denise is the lead instructor of EduQuest’s 1.5-day training class, The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations, and Complaint Management.


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