Proactive Patient Safety Initiatives: FMEA

Be able to analyse, track Patient safety issues both qualitatively and quantitatively.

Failure Mode and Effects Analysis (FMEA)

Analyzing what may happen wrong before it happens is the basic idea of risk management. The ability to recognize, prioritize, and plan for a risk, or “failure” of an aspect of the system, and reduce danger and side-effects to patients and save money for the company. FMEA is used across industry n the planning stages before significant production is begun to reduce the costliness of restarts, retooling, or adjusting a plan.

FMEA is a qualitative and systemic tool which uses a spreadsheet to predict What may fail, What the failure will effect, and If that failure is predictable.

FMEA analysis should include all the participants who are involved with the system, from practitioners, staff, and some cases the patient or vendor, if the end result is determined by their actions.

Spreadsheet layout:

Function or Process Step Failure Type Potential Impact SEV Potential Causes OCC Detection Mode DET RPN
Briefly outline function, step or item being analyzed Describe what has gone wrong What is the impact on the key output variables or internal requirements? How severe is the effect to the customer? What causes the key input to go wrong? How frequently is this likely to occur? What are the existing controls that either prevent the failure from occurring or detect it should it occur? How easy is it to detect? Risk priority numb

An FMEA uses three criteria to assess a problem: 1) the severity of the effect on the customer, 2) how frequently the problem is likely to occur and 3) how easily the problem can be detected. Participants must set and agree on a ranking between 1 and 10 (1 = low, 10 = high) for the severity, occurrence and detection level for each of the failure modes. Although FMEA is a qualitative process, it is important to use data (if available) to qualify the decisions the team makes regarding these ratings.

Issues with higher numbers are ranking highest priority, Now effort and focus can be used depending on importance.

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