FMEA (Failure Mode and Effect Analysis) 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.
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.
Besides taking actions to eliminate or reduce failures, starting with the highest-priority ones, failure modes and effects analysis also documents current knowledge and actions about the risks of failures, for use in continuous improvement.
FMEA is used during design to prevent failures. Later it’s used for control, before and during ongoing operation of the process. Ideally, FMEA begins during the earliest conceptual stages of design and continues throughout the life of the product or service.
FMEA is also used for many more purposes, such as:
- When a process, product, or service is being designed or redesigned, after quality function deployment (QFD)
- When an existing process, product, or service is being applied in a new way
- Before developing control plans for a new or modified process
- When improvement goals are planned for an existing process, product, or service
- When analyzing failures of an existing process, product, or service
- Periodically throughout the life of the process, product, or service
Want to learn more? Tonex offers FMEA Training, a 2-day course that covers the procedures, tools and methods on how to identify potential modes of failure prior to the launch of a new product/system or modifying an existing one. Attendees learn how to choose tools and manage projects and teams to effectively carry out FMEA processes.
FMEA training will also teach attendees how to reduce organization’s risk of costly mistakes and how to identify potential modes of failure before launching a new product or modifying an existing one.
FMEA for Medical Devices (2 days)
Applied Failure Mode and Effects Analysis Workshop (2 days)
For more information, questions, comments, contact us