Failure Modes and Effect Analysis (FMEA) is a process to better understand how a system or equipment is likely to fail. The purpose of an FMEA is to take proactive actions within the design, maintenance, and operation to reduce the likelihood of failure and the consequence if it does occur.
Failures examples:
1. Safety event
2. Environmental compliance
3. Equipment damage
4. Healthcare procedure error
5. Product warranty
An FMEA is a step-by-step process to identify the potential failures in a system, equipment, operations, product, or service. It is comprised of:
Failure modes – the individual ways that failure can occur. Failure is defined by the end user or the customer, which may have a different definition than the manufacturer or service provider.
Effects analysis – the consequence or the effect of the failure. Understanding the first and second order effects from a potential failure.
Failure modes are prioritized by:
1. Severity of the potential event
2. How likely they are to occur
3. How simple to detect the oncoming event
An FMEA team will focus on the highest consequences and the most likely to occur. Many of the lower priority failures will have an acceptable risk.
When to complete an FMEA?
1. Analyzing actual or potential failures of a system, equipment, or process
2. Analyzing potential safety events
3. Ensuring environmental compliance
4. Reviewing a product design
5. Evaluating a process