What we know to be true is root cause analysis (RCA) plays a vital role in the development, manufacturing, and use of medical devices. When we are able to successfully identify and address the underlying causes of failures or errors, using RCA as a tool in your operation helps to improve the safety, reliability, and effectiveness of medical devices.
When done correctly, RCA has a significant impact on medical devices by enhancing patient safety, improving design and manufacturing processes, ensuring regulatory compliance, driving product improvement and iteration, mitigating risks, and supporting post-market surveillance efforts. While all of this may sound common sense, what's most important is when RCA is used and done correctly.
In this episode of Medtech Snapshot we're joined by Quality Executive Robert Lahaderne to talk Root Cause Analysis (RCA)! Hear how Robert shares his perspective on the impact Root Cause makes to a medical device organization when it is done correct versus when it is done incorrectly and how rushing through FMEAs and hazard analysis creating unnecessary challenges down the road.
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About the Author
Travis Smith is the founder and managing director of Square-1 Engineering, a life sciences consulting firm, providing end to end technical project services to companies which design, develop and or manufacture products in Southern California. He successfully served the life sciences marketplace in SoCal for over 15 years specializing in engineering services, consulting, project outsourcing and leadership development. In 2019 he was recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA.