Challenge: Prioritizing the “Preventive” in “Corrective and Preventive Actions”

When QualityHub is brought on to do CAPA system revisions, it is often more reactive than proactive. However, one particular client — a major international pharmaceutical and medical device company — noticed shortcomings and wanted to take a more proactive approach to their CAPA system. 

The Client lacked confidence in their CAPA process; it lacked the rigidity and cohesion across multiple departments and divisions.The FDA had also already been in touch regarding a few regulatory issues, and the Client wanted to take proactive steps to stop FDA enforcement  before they went further. The Client also understood that with their cross-industry nature, the FDA regulations would require them to follow CAPA guidelines across every single company sector — rather than solely pharma or solely medical. The Client approached QualityHub to create a new CAPA process that would work across multiple business sectors  and provide a reliable infrastructure to mitigate issues in the future. 

Approach: CAPA Training and Collaboration

We provided the Client with baseline gap analyses for their companies and those companies’ respective departments. QualityHub needed to create a CAPA process that could be cross applied and sensible for each department, while also upholding FDA regulations. 

QualityHub then trained a cadre of 300 people over the span of three days on the new CAPA system. We trained more than just the quality team; leaders in design controls, operation, production and more all learned how to conduct root cause analysis within their respective departments — thus writing more successful CAPAs. Those 300 leaders then went and trained the Client’s 40,000+ employees. 

The Client wanted to make sure that the new CAPA system was adequate  and that training was being properly applied. QualityHub stayed for an additional two years following deployment of the CAPA system. Each department regularly sent CAPAs to our experts, who then scored the CAPAs based on meeting FDA approval, and sent those scores back to the Client. The Client also assigned a corporate CAPA manager to distribute the scores and provide additional feedback. 

Results: Impressing the FDA with a New CAPA System

This data-driven approach to performance helped stabilize the CAPA system changes across all departments. The ongoing assessments  during the additional two-year period showed great improvements over time. It also helped build ownership of the CAPA process within departments, rather than loading the burden onto Quality Assurance teams. Departments could remain vigilant and proactive rather than reactive to issues. 

The results of this Client remain some of our favorite memories. Upon later inspecting the Client, the FDA told them they had one of the best CAPA systems the FDA had ever seen. That spoke volumes to the time, energy and resources the Client invested in a system that truly embraced the importance of being proactive.