Vinky Kohli explores how addressing human factors can transform RCA processes in the medical device industry.

Root Cause Analysis (RCA) is a cornerstone process for identifying and resolving nonconformities in the medical device industry. Yet, a critical aspect often overlooked is the role of human error. In her online-exclusive article “Understanding Human Errors in Medical Device Root Cause Analysis” for Medical Product Outsourcing (MPO), StarFish Medical’s Vinky Kohli examines how integrating human factors into RCA can lead to safer devices and improved processes.

Kohli emphasizes that human errors are not random but are influenced by systemic, environmental, and cognitive factors. Addressing these root causes can prevent recurring issues and strengthen RCA outcomes.

Key insights include:

• The Role of Human Factors: Drawing lessons from the aerospace industry, Kohli advocates incorporating human factors engineering into RCA. This includes understanding contributors like lack of communication, fatigue, and stress, collectively known as the “Dirty Dozen.”
• Enhancing RCA Tools: Standard tools like the 5 Whys, fishbone diagrams, and Failure Modes and Effects Analysis (FMEA) are valuable but benefit significantly from human factors analysis to uncover deeper insights.
• Practical Strategies: Kohli offers actionable recommendations, such as continuous training, fostering cross-functional collaboration, leveraging technology, and standardizing RCA procedures to reduce errors effectively.

Kohli challenges the common attribution of nonconformities to “human error” alone. Instead, she advocates for a deeper investigation into systemic issues like unclear standard operating procedures (SOPs) or inadequate training. By addressing these factors, medical device manufacturers can implement more effective Corrective and Preventive Actions (CAPA) and build a culture of continuous improvement.