Failure Mode and Effect Analysis (FMEA) is a failure analysis that identifies and ranks potential problems and their effects.
FMEA proactively looks for errors earlier in the product lifecycle process to improve process and product with the goal of reducing costs and problems that may lead to expensive recalls.
Another way of looking at it:
Failure Mode and Effects Analysis is a living document that records all potential product and process failures and minimizes risk of product and process failures through corrective action. FMEA also documents results and insights for current and future product and process success.
The aerospace, nautical and automotive industries have used FMEA extensively for many years. As far back as the 1960s, FMEA received considerable attention when NASA used it in their Apollo missions.
The point is, FMEA has been around so long because it works as a preemptive look into identifying potential problems earlier in the design process. This is an important cost savings measure for organizations and agencies because scrap, rework, defects, retesting, and recalls are expensive.
Reducing costs and problems later in the product lifecycle improves product and process reliability, quality, and safety, which results in better customer satisfaction.
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.
FMEA Course by Tonex
Tonex offers several 2-day courses in FMEA that cover key aspects on how to effectively carry out Failure Mode and Effects Analysis. Participants learn how FMEA is best used and when it should be implemented by organizations and agencies.
Special types of FMEAs are also covered such as Design FMEA. Important industrial uses like how FMEA fits into healthcare (FMEA for Medical Devices) are delved into as well.