Calculating risk in a Failure Mode and Effects Analysis (FMEA) involves assessing potential failures in a system, product, or process, and quantifying their associated risks. The primary steps to calculate risk in an FMEA are:
1. **Identify Failure Modes and Effects**
– List out each possible failure mode for a component, process, or function. This is essentially identifying *what could go wrong*.
– Describe the effect of each failure mode on the system or customer. This answers the question *what would happen if this failure occurred?*
2. **Determine the Causes of Each Failure Mode**
– Identify the possible causes or reasons for each failure mode. This step helps in understanding the root causes, which are critical to risk mitigation.
3. **Evaluate Severity (S)**
– Rate the *Severity (S)* of each failure mode, typically on a scale from 1 to 10, where 1 is insignificant, and 10 is catastrophic. Severity measures the impact of the failure on the system, process, or customer.
– Higher severity indicates a more serious impact and, consequently, a higher risk if the failure occurs.
4. **Evaluate Occurrence (O)**
– Rate the *Occurrence (O)* of each failure cause, again usually on a scale from 1 to 10. Occurrence measures the likelihood that the cause of the failure mode will occur.
– Higher occurrence ratings indicate a greater probability of the failure happening.
5. **Evaluate Detection (D)**
– Rate the *Detection (D)* for each failure mode or cause on a scale from 1 to 10. Detection assesses how likely it is that the failure will be detected before reaching the customer or causing a significant impact.
– A lower detection rating indicates a higher likelihood that the failure will be detected, whereas a higher detection rating implies a lower chance of detection.
6. **Calculate the Risk Priority Number (RPN)**
– Calculate the *Risk Priority Number (RPN)* for each failure mode using the formula:
RPN = S * O *times D
– The RPN is a quantitative measure of the risk associated with each failure mode. Higher RPN values indicate higher risks and signal the need for priority action.
7. **Set Thresholds and Prioritize Risks**
– Establish an acceptable RPN threshold based on your organization’s risk tolerance. Failure modes with RPN values above this threshold are considered high-risk and should be prioritized for action.
– Organize failure modes in descending order of RPN to help decide which ones require the most immediate attention.
8. **Develop and Implement Risk Mitigation Actions**
– For failure modes with high RPN values, develop actions to reduce severity, occurrence, or improve detection.
– These actions could involve design changes, process improvements, or additional testing and inspection procedures.
9. **Recalculate RPN After Implementing Mitigation Actions**
– Once risk mitigation actions are implemented, reevaluate the Severity, Occurrence, and Detection ratings and recalculate the RPN.
– Compare the new RPN values with initial values to assess the effectiveness of the actions and ensure that the risk is reduced to an acceptable level.
10. **Document and Review Regularly**
– Document all findings, RPN scores, and mitigation actions. Review the FMEA periodically, especially when design or process changes occur, to ensure that it remains relevant and effective in controlling risk.
By following these steps, the FMEA process enables organizations to prioritize risks, make informed decisions about mitigation actions, and continuously improve the reliability of products or processes.