March 14, 2011

Traceability Exercises to Help Avoid an FDA 483 Warning

We recently wrapped up development of a workbook with 6 specific exercises to help an organization improve traceability practices. These are exercises that you can complete in as little as a couple hours, or you can break them up and spend more time on each one over the course of one or more weeks. The exercises help your team/company discuss current development and quality challenges, understand overall quality and compliance requirements, and determine best practices to adopt going forward. The goal being to boost quality and improve your compliance with FDA regulations. I was reminded of the importance of meeting FDA regulations with the stumble at Johnson & Johnson, when their Cordis unit was hit with a 483 warning letter in February. Maybe it's because of our focus on the traceability workbook recently, but one passage in particular struck me as especially instructive:

"FDA expectation is that devices comply with their predetermined specifications and design out-put at the time of release/use and not relying on the end users to address nonconforming products."

That, to me, nicely sums up the need for robust traceability within your product development and manufacturing processes. You need to be verifying and validating conformance with the product design and you need to be able to prove to the FDA that you're doing it. It's a case where the whole process is greater than the sum of its parts. If requirements (and associated changes) aren't effectively communicated to the team throughout the lifecycle, conformance is going to suffer. If you can't effectively generate a trace matrix and associated documents to prove that conformance, compliance is going to suffer. If you're interested in learning more about the traceability exercises, download the workbook "Six Exercises to Strengthen Traceability."