FMEA Software is an analytical methodology used to ensure that potential problems have been considered and addressed throughout the product and process development process. Part of the evaluation and analysis is the assessment of risk.

The important point is that a discussion is conducted regarding the design (product or process), a review of the functions and any application changes, and the resulting risk of potential failure.

Failure Modes and Effects Analysis (FMEA) is a systematic, proactive method for evaluating a process to identify where and how it might fail to assess the relative impact of different failures and to identify the parts of the process that are most in need of change. FMEA software includes a 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 Software to evaluate processes for possible failures and prevent them by correcting them proactively rather than reacting to adverse events after failures have occurred.

This emphasis on prevention may reduce the risk of harm to both patients and staff. FMEA is particularly useful in evaluating a new process before implementation and assessing the impact of a proposed change on an existing process.

The elements of FMEA Software

1. Item or Process Step: A DFMEA refers to an Item and a PFMEA to a Process Step as a starting point of the analysis. You perform the analysis on an Item or a Process Step.
2. Function: Function is the system’s task to satisfy the customer’s quality or performance expectations. If functions from all the above categories are considered, the FMEA becomes a lot more comprehensive.
3. Requirement: A requirement is a technical specification or a numerical measure of the desired function. Being a technical measure, this needs to be described from the Designer’s point of view.
4. Failure Mode: A Failure Mode is the negation of the requirement. It is a description of how a requirement is not met with. A Failure Mode needs to be described from the Customer’s as well as the Designer’s point of view. It can be identified by both.
5. Effects and their respective Severities: Once a failure mode is identified, the team takes it up for detailed analysis. A failure will lead to many effects. Some effects are more severe in consequences, others less.
6. Causes, Occurrence & Detection rankings and Current Controls: Causes are mechanisms or events that lead to failure. These are identified by the analyst. The Cause descriptions should be written therefore as perceived by the designer.
7. Risk Priority Number (RPN): The Risk Priority Number for every Cause is the multiplication: Occurrence Ranking X Detection Ranking X Highest Severity Ranking associated with the Failure Mode. The RPN is one of the metrics that help you prioritize causes with high risks on which actions need to be taken.
8. Actions: Actions need to be taken on causes. Several actions can be taken to address the potential risk associated with the cause.

Failure Modes and Effects Analysis (FMEA software) is a systematic, proactive method for evaluating a process to identify where and how it might fail to assess the relative impact of different failures and to identify the parts of the process that are most in need of change. Teams use FMEA software to evaluate processes for possible failures and prevent them by correcting them proactively rather than reacting to adverse events after failures have occurred. This emphasis on prevention may reduce the risk of harm to both patients and staff. FMEA software is particularly useful in evaluating a new process before implementation and assessing the impact of a proposed change on an existing

Each one of the effects identified with the failure mode must be noted along with its severity ranking. The severity ranking is a number on the 1- 9 scale that tells you about how serious that effect of failure is. Rank 1 is for the least severe failure and rank 9 is for the most severe one.

Effects should always be written as perceived by the customer. One failure mode will lead to many effects. Thus potentially every effect identified can occur once the Failure occurs. This means that the most serious effect can also occur once the Failure occurs.

The demo of the FMEA Software is here: https://gestat.io/fmea

FMEA Web Software