FMEAs help us focus on and understand the impact of potential process or product risks.
FMEA studies provide the means to evaluate risk levels thereby establishing a mechanism to prioritize risks. They lead us through a step-by-step approach of analyzing the design or process, understanding how it is supposed to function, identifying how it can fail to function as intended, determining the consequences of the potential failures, assessing the impact of the consequences, the frequency of occurrence and the ability to detect the failure. All of this information is used to prioritize actions that will lead to risk reduction and process improvement.
Make FMEAs “Living Documents”
While an FMEA is a specific project taken on by a team, FMEAs become living documents by assuring they are always kept up to date when major changes are made to the design or process. Pull any FMEA out of the electronic file cabinet and it should reflect the most current version of the product or process.
Linking FMEAs to Control Plans
- Use FMEAs as the basis for Control Plans.
- Control Plans are a summary of proactive defect prevention, reactive detection techniques, and a well-thought out Reaction Plan if a failure does occur.