FDA inspection reports consistently show that the corrective and preventive action process is the biggest inspection problem for medical device facilities. And those who have to implement CAPAs have plenty of questions about how best to manage them.
Quality management expert Jon Speer, founder and vice president of QA/RA at Greenlight Guru, addressed some of the main issues that plague those who work with CAPAs in the device industry, in a recent FDAnews webinar “How to Implement and Maintain a Modern CAPA System While Avoiding Common Pitfalls and Mistakes.”
For example, device companies may not be clear on whether it’s advantageous to keep their CAPA system separate from other systems like those used for training and complaints — or integrated with them. Speer advises keeping all the information together in one integrated system.
“You need a system where all of these disparate parts of your quality system are connected together in one single source so that you can use the information, that data, to make informed decisions that impact the quality of your products and processes,” he said.
“Audits, CAPAs, complaints, non-conformances, all of these records that we’re generating — these are the proof, the evidence that we did what we said we were going to do, the evidence that things are documented in a way that shows that our products are safe and effective.”
Another common concern: What is a good balance between corrective to preventative CAPAs? Speer said there is no magic ratio, though in general it’s much preferred that most of the energy spent goes toward prevention. Unfortunately, however, that’s not the current state of affairs.
“It’s overwhelmingly skewed toward being greater than 80 percent corrective in nature now,” he said. “The first step is for us to get our ratio of corrective to preventative more in a one-to-one relationship rather than a four-to-one type of relationship. Try to shift in that direction.”