Dig Deep and Do Medical Device Root Cause Analysis the Right Way

This is the first post in a 4-part blog series on medical device root cause analysis. In subsequent posts we will talk about problem scoping, formulating a plan, and root cause verification. We’ve combined all four posts into one easy-to-read PDF, plus added some extras. Download it here. “Never try to solve all the problems at once — make them line up for you one-by-one.” This quote by author Richard Sloma captures the essence of effective root cause analysis. When […]

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CAPA and P&PC: How to Handle These Two Medical Device Compliance Troublemakers

What can FDA’s data tell you? Sometimes you learn something new ‒ other times the data validates what you already know. FDA’s CY 2016 Annual FDA Medical Device Quality System Data reveals that Corrective and Preventive Action (CAPA) and Production and Process Controls (P&PC) continue to cause compliance headaches for medical device manufacturers. The data addresses findings related to five quality system subsystem areas: Corrective and Preventive Action (CAPA), Production and Process Controls (P&PC), Management Controls (MGMT), Design Controls (DES), […]

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