Which statement about risk assessment approaches is true?

• A. FMEA provides granular, step-by-step evaluation of specific failure modes and effects.
• B. FMEA is used to categorize broad risk categories without considering individual failures.
• C. High-level risk assessment is always more detailed than FMEA.
• D. A formal risk assessment is optional in device development.

Answer: (C)

Understanding risk assessment approaches means recognizing how detailed the analysis is and what it covers. FMEA is a granular, step-by-step method that examines each potential failure mode of a component or process, describes its effects, considers possible causes, and evaluates current controls. It then uses scoring for severity, likelihood, and detection to prioritize improvements. This level of detail makes FMEA a very specific, failure-mode–level analysis.

High-level risk assessment, on the other hand, looks at hazards and risks in broader terms. It focuses on major categories and overall risk picture rather than drilling into every individual failure mode. It’s useful early in development to spot major concerns and determine where to devote deeper analysis later.

Because of this difference in scope and granularity, the statement that high-level risk assessment is always more detailed than FMEA isn’t accurate. The more detailed approach is the FMEA, not the high-level assessment. In medical device development, a formal risk assessment is not optional; standards like ISO 14971 require structured risk management throughout design and use.