Process FMEA

Performing FMEA of the complex process in its entirety would be a time-consuming, impractical and overwhelming exercise for many healthcare teams. It is more effective to focus on carefully selected and manageable sub-processes that have a significant impact on patient safety and health outcomes. For example, instead of analyzing the entire hospital medication management process, the FMEA team may initially target only medication dispensing process. Some of the processes commonly selected for FMEA include patient admission to the hospital, patient identification, pre-operative assessment, verification of correct surgical procedure and site, specimen collection, appointment scheduling, medication administration, blood transfusion, patient discharge, patient transfer, and many others. The figure below outlines a general approach for conducting a process FMEA, but specific steps as well as severity, occurrence and detection rating scales may vary considerably in different organizations.

 

FMEA Process

 

The process controls refer to existing policies, procedures, practices, standards, inspections, internal audits, employee training, technology, equipment, and other mechanisms designed to prevent failures from reaching the patient, reduce severity of failures, reduce likelihood of occurrence, or increase likelihood of detection. The Risk Priority Number (RPN) is the product of the severity (S), occurrence (O), and detection (D) ratings (RPN = S x O x D). The RPN is essentially a numeric, quantitative value of the process risk and it helps the team focus on key areas of risk and prioritize improvement opportunities. The RPN for the entire process is obtained by adding up all the individual RPNs calculated for each failure mode. Failure modes with high RPNs must be given the highest priority when developing, prioritizing, testing, and implementing preventive and corrective actions or driving technological innovation. In the final step, the team needs to recalculate the RPNs for each failure mode and use appropriate performance measures to determine if the preventive and corrective actions have actually produced desired outcomes. The FMEA worksheet should be updated on a regular basis and analysis repeated until all potential failure modes pose an acceptable level of risk.

 

Process FMEA Example

 

It is important to recognize that the relationship between the failure mode and the effect is not always one-to-one. One failure mode can result in more than one effect and conversely, several failure modes can result in the same effect. For example, a single failure mode such as patient identification error can result in several effects including wrong diagnosis, unnecessary exposure to radiation, delay in treatment, wrong treatment, wrong site surgery, etc. Potential failure modes associated with the medication administration process such as drawing incorrect dose from the vial or selecting wrong medication from the shelf can both result in the same effect – a serious adverse drug event. The figure below illustrates a variety of relationships between the failure modes and the effects.

 

FME Relationships