Greenlight Guru Podcast Recap: Human Factors & Risk Management: What's Needed & Why

Human Factors & Risk Management: What's Needed & Why

Watch the podcast, Click here, or you can listen by clicking below.

Highlights include:

  • Human factors is a risk management activity that the FDA and International Organization for Standardization (ISO) requests. It’s all about use-related risk.

  • Risk management helps make design decisions around safety and efficacy, and human factors provide a focused view on user- and use-related risks.

  • The main contributor that companies come across are deficiencies and questions regarding the human factors process, including the use-related risk assessment.

  • Probability and occurrence is challenging for most people. To understand product risk, understand risk is probability and disparity. To know what’s driving human factors, understand what could lead to high-disparity harm or kill someone.

  • Based on user needs and human behavior, risk management helps companies understand users, how they interact with your product, and what can go wrong.

  • Step-by-step process of risk assessment is to identify all tasks, identify what can go wrong, stay focused to build information, and then identify solutions.

  • Product development engineers want their product to be safe and work. Embrace human factors to improve that as a likelihood. Do not resist it.

Agilis