Failure Mode & Effects Analysis is a step by step risk assessment tool for identifying failures within a design (DFMEA) of a product or service and processes (PFMEA). The structured approach evaluates the level of severity, how often the failure occurs and prioritizes which ones need handling first. Begun in the 1940s by the military, it is a standard process analysis tool that contributes to continuous improvement.
FMEA is Made Up of Two Parts
Failure Modes – ways in which something might fail. These are errors or defects that can affect either the end quality or affect customers. The failures can be potential failures or actual failures.
Effects Analysis – The study of the consequences of the failures. Effects usually result in waste, product defects or harmful outcomes to the customer.
Each failure and effect is prioritized based upon a scoring matrix with 3 categories with a 1 – 10 scale. The categories are severity, occurrence, and detection. The results of these categories are then multiplied together to give the risk an overall Risk Priority Number (RPN). How to handle the risk is then determined by the RPN.
The process of FMEA varies slightly by industry or organization but follows 7 basic steps, with individual steps handled by appropriate team members with the required knowledge to avoid pitfalls and improve the effectiveness of the analysis.
Any organization that uses a process to develop a product or provides a service should perform an FMEA. The analysis not only aids in ensuring a top-quality product or service, and a safe process but can aid in documenting the current understanding of risks and actions taken as part of continuous improvements.
Who Should Perform an FMEA
A cross-functional team of people with knowledge of the process, product or service and the needs of the customer should be assembled to work on the analysis. Their knowledge should be diverse to include functions such as design, manufacturing, quality, testing, reliability, purchasing, sales, marketing, maintenance, and customer service to ensure that every step of the process and aspect of the product or service is considered.
When Should an FMEA be Performed
An FMEA should be performed in any of the following situations:
- At the beginning of a process, when the product or service is being designed and should continue throughout the entire life of the product or service.
- When the process, product or service is being applied in a new way or being re-designed.
- Before developing control plans, or improvement goals for an existing process.
- When existing failures are being analyzed in processes, products or services.
- Repeatedly throughout the life of the process, product or service to aid in continuous improvement.
Looking for help to create an FMEA? Contact McDonald Consulting Group to help. We will help you evaluate your needs, and come up with the most cost-effective solution with easy implementation for your organization. McDonald Consulting Group offers both in-house classes (which may be customized) and public offerings.