Safety Games: FMEA & MIA

True or False: A failure mode and effects analysis (FMEA) is a retrospective analysis.

• True

• False

Which of the following is NOT a goal of an FMEA?

• Investigate causes of an incident.

• Evaluate systems and processes.

• Identify and correct vulnerabilities.

• Improve overall quality and safety.

True or False: An FMEA focuses on how and when a system will fail, not if it will fail.

• True

• False

What is FMEA typically conducted for? Choose ALL that apply.

I. High-risk processes in which a failure is most likely to jeopardize safety

II. Processes that have produced a high number of incidents

III. An incident that has resulted in severe harm

IV. When designing a new system or process

• I, II, and IV

• I and IV

• II and IV

• All of the above

What is the maximum of a criticality score?

• 4

• 5

• 100

• 125

How to prioritize potential failure modes identified in an FMEA? Choose ALL that apply.

I. Determine a "cut-off" criticality score

II. Plan to address 60-70% of identified failure modes

III. Include any failure modes with a severity of 4, regardless of criticality score

• I and II

• II and III

• I and III

• All of the above

Which of the following is NOT an appropriate method to analyze and test the changes in an FMEA?

• Recalculating the criticality score.

• Conduct a new FMEA if substantial changes have been made.

• Maximize the number of processes impacted in the pilot test.

• Assess unanticipated problems with simulation or usability tests.

True or False: A multi-incident analysis (MIA) is a retrospective analysis.

• True

• False

True or False: An MIA refers to the analysis of a group of medication incidents with pre-defined common factors.

• True

• False

Incidents of ____ harm levels are typically included in an MIA. Choose ALL that apply.

I. No harm

II. Low harm

III. Medium harm

IV. Severe harm

• I and II

• II and III

• I, II, and III

• All of the above