Definition
Failure Modes and Effects Analysis (FMEA) is a systematic, proactive method of evaluating a process. An FMEA identifies the opportunities for failure, or "failure modes," in each step of the process. Each failure mode gets a numeric score that quantifies (a) likelihood that the failure will occur, (b) likelihood that the failure will not be detected, and (c) the amount of harm or damage the failure mode may cause to a person or to equipment. The product of these three scores is the Risk Priority Number (RPN) for that failure mode. The sum of the RPNs for the failure modes is the overall RPN for the process. As an organization works to improve a process, it can anticipate and compare the effects of proposed changes by calculating hypothetical RPNs of different scenarios. Just remember that the RPN is a measure for comparison within one process only; it is not a measure for comparing risk between processes or organizations.
Formula: The Risk Priority Number, or RPN, is a numeric assessment of risk assigned to a process, or steps in a process, as part of Failure Modes and Effects Analysis (FMEA), in which a team assigns each failure mode numeric values that quantify likelihood of occurrence, likelihood of detection, and severity of impact.
Goal
Decrease the RPN for a given high-risk process by 50 percent within 1 year.
Data Collection Plan
Using the Failure Modes and Effects Analysis (FMEA) Tool, conduct a thorough analysis of a high-risk process in the organization, assigning numeric values to each failure mode per the instructions, and generate an RPN. Recalculate the estimated RPN each time you consider a change to the process, to evaluate the possible impact of the change. Recalculate the actual RPN only after a change has been tested and made a permanent part of the process.
