Explain Failure Mode and Effects Analysis (FMEA) and its steps as applied to medication processes.

• A. Reactive incident analysis.
• B. Proactive risk assessment; steps include mapping the process, identifying potential failure modes, scoring severity/occurrence/detectability, prioritizing, and implementing controls.
• C. Marketing plan development.
• D. Training schedule for staff only.

Answer: (B)

Failure Mode and Effects Analysis is a proactive, systematic way to identify where medication processes could fail and to prevent those failures before they harm patients. The approach starts by mapping the entire medication process—from prescribing to administration and monitoring. At each step, the team identifies potential ways things could go wrong and considers the possible effects on patient safety. For each potential failure mode, they assign scores for how severe the impact would be, how likely the failure is to occur, and how likely it is to be detected before affecting the patient. These three factors are combined to prioritize which risks to address first. The team then designs and implements controls—such as process changes, safeguards, or training—and monitors the results, revisiting the analysis to ensure improvements are effective.

This reflects the essence of the method: thinking ahead about possible errors, measuring their risk, and putting in place preventive steps to reduce or eliminate those risks in medication workflows. The other options describe post-hoc analysis, a marketing plan, or a training schedule, none of which align with the proactive, risk-focused nature of FMEA.