FMEAs help us focus on and understand the impact of potential process or product risks.
A systematic methodology is used to rate the risks relative to each other.
An RPN, or Risk Priority Number, is calculated for each failure mode and its resulting effect(s).
The RPN is a function of three factors: The Severity of the effect, the frequency of Occurrence of the cause of the failure, and the ability to Detect the failure or effect.
The RPN = The Severity ranking X the Occurrence ranking X the Detection ranking.
The RPN can range from a low of 1 to a high of 1,000.
Develop an Action Plan to reduce risks with unacceptably high RPNs.
Use FMEAs as the basis for Control Plans. Control Plans are a summary of proactive defect prevention and reactive detection techniques.
Assembling an FMEA Team
FMEAs should always be conducted by teams.
The best size for an FMEA team is 4 to 6 people, carefully selected, based on the contribution they can make to the specific FMEA.
An FMEA team should represent a cross-section of the company in terms of functional responsibility and level in the organization. Team members typically come from:
R & D
FMEA team members do not necessarily need to have extensive knowledge of the design or process being targeted. In fact, sometimes it helps to get an outsider's fresh perspective.
The FMEA team needs a leader to help set up and facilitate meetings, to ensure the team has the necessary resources, and to make sure the team is progressing toward completion of the FMEA.