Did you know that one of the top three causes of 483 observations is because manufacturers fail to correctly use their CAPA processes? How did BioTeknica help a client with an ineffective CAPA process eliminate repeat CAPAs for similar nonconformance events? The results were startling.


As the “Do Re Mi song” says, “Let’s start at the very beginning; a very good place to start.  When you read you begin with A-B-C,” similarly when you receive a 483 you begin with C-A-P-A … well, you get the idea.

Let’s start with the basics; what is a 483 observation?  Briefly, it’s a notice from the FDA that highlights a company’s regulatory violations for their equipment, facility, processes, employee practices, records, etc., that are found during a routine inspection.  If you don’t demonstrate to the FDA that you’ve correctly handled the problem, the 483 may be followed with a Warning Letter, a notice of serious violations with your internal systems.

The agency expects device manufacturers to implement corrective and preventive actions (CAPA) into their quality systems.  In effect, CAPA, a subsystem of a company’s quality system, is a systemic strategy to reduce risks and improve processes.  Corrective actions are taken to prevent recurrence of an undesirable situation, or a nonconformity, and preventive actions are taken to prevent an occurrence.

Situation:  Ineffective CAPA Process

Problems often occur when a company doesn’t have a structured approach to identifying potential problems and their root causes, and developing and documenting solutions so that similar problems don’t arise in the future.  This was the situation for a client who had an inconsistent and ineffective application of CAPA, including inputs into the process and the elevation of significant issues into the risk management process.

Challenge:  Inadequate CAPA Process & Documentation

There were several challenges that we faced:

  • Inputs into the CAPA process from key subsystems such as complaints, process nonconformances, failure analysis center, etc., were not well-defined
  • The CAPA process was inadequate, since issues frequently re-occurred
  • CAPA documentation was inadequate; to understand the investigation performed and actions taken associated with the issue would require interview(s) of the CAPA file owners and other participants.  Employee turnover had led to an inability of the client to “tell the story”

Solutions:  Root Causes & New Processes

Our team reviewed and improved all key inputs into the CAPA process in three major areas:

  • Complaints: The process was improved by better defining inputs, partly by creating a product-specific complaint, and MDR (Medical Device Reporting) decision tree training.  Another element was implementing valid triggers into the CAPA request process
  • Significant One-Time Events:  We created and implemented a definition for significant one-time events
  • Effective Screening:  We helped them understand which issues should be managed in a lower level system such as the nonconforming system process versus CAPA.

We also:

  • Instituted a CAPA process primarily based upon the DMAIC (Define Measure Analyze Improve Control) methodology
  • Created a dual-path CAPA process, which improved quality and dramatically reduced cycle times
  • Implemented a two-tier management review system that helps ensure key issues are raised to the Executive Management team
  • Conducted both interactive workshops and “read-and-understand” trainings
  • Dramatically improved documentation with standardized tools and templates and instituted a required peer review of the CAPA file after key stages of the process

Results:  Improved CAPA and Feeder Systems

The client improved the CAPA file investigation, root cause identification, and documentation quality along with significant improvement in CAPA closure timeliness.  Key CAPA process improvements included:

  • Creation of a risk-based approach to CAPA, which allowed for alignment of critical resources and dramatic reduction of critical CAPA timeliness from months to weeks
  • Integrated approach between the CAPA, risk management, and management review processes to ensure timely notification to executive management, immediate resource decisions, and improved regulatory notification processes
  • Dramatic improvement of CAPA file documentation; first-pass acceptance through the CAPA peer review process improved from weeks to days
  • Improvements to CAPA inputs, including a strong tie between complaints, field service, and in-house repair/complaint evaluation processes; this process allowed for earlier detection of evolving issues

Over a three-year period, the site was able to dramatically improve CAPA and related system processes.  In a recent inspection, an Investigator from FDA complimented the site on improvements made to the site quality system.