Failure Mode and Effect Analysis (FMEA) is often used when a process, product, or service is being designed or redesigned, after quality function deployment (QFD), or when an existing process, product, or service is being applied in a new way.
FMEA is also used by organizations before developing control plans for a new or modified process, or when improvement goals are planned for an existing process, product or service.
Failure Modes and Effects Analysis (FMEA) is a systematic, proactive method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change.
FMEA includes review of the following:
- Steps in the process
- Failure modes (What could go wrong?)
- Failure causes (Why would the failure happen?)
- Failure effects (What would be the consequences of each failure?)
Teams use FMEA to evaluate processes for possible failures and to prevent them by correcting the processes proactively rather than reacting to adverse events after failures have occurred. This emphasis on prevention may reduce risk of harm to both patients and staff. FMEA is particularly useful in evaluating a new process before implementation and in assessing the impact of a proposed change to an existing process.
With an FMEA, each failure and its corresponding effect are rated on the three different scales and a Risk Priority Number (RPN) is calculated by multiplying the three ratings for each item. This provides a powerful way to evaluate the risk of each failure against the others.
FMEAs have been around since the 1950s when reliability engineers used them to study potential problems with DoD systems. Safety Engineers at DuPont adapted the FMEA process to understand potential industrial hazards and to prevent accidents. For several decades automotive manufacturers have required key suppliers to provide evidence that FMEAs have been done for key processes and designs.
Want to learn more? Tonex offers several courses in FMEA, such as:
FMEA for Medical Devices (2 days)
Applied Failure Mode and Effects Analysis Workshop (2 days)
For more information, questions, comments, contact us