Explore our comprehensive Failure Mode and Effects Analysis Template, a systematic approach to identify, analyze, and mitigate potential failure risks in systems.
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Identify the system to be analyzed
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Establish the team responsible for the FMEA
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Identify potential failure modes
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Identify potential effects of each failure mode
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Determine the severity ranking of each failure mode
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Approval: Severity Ranking
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Identify potential root causes of each failure mode
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Determine the occurrence ranking for each root cause
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Approval: Occurrence Ranking
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Identify existing process controls
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Determine the detection ranking for each control
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Calculate the risk priority number for each failure mode
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Evaluate the need for further action based on RPN
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Approval: Action Plan
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Implement the action plan
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Review the effectiveness of the action
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Approval: Effectiveness Review
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Update the FMEA as necessary
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Document the FMEA process and results
Identify the system to be analyzed
In this task, you need to identify the specific system that will be analyzed as part of the Failure Mode and Effects Analysis (FMEA). This system can be a product, a process, or any other component that is critical to the overall operations. The identification of the system is crucial as it provides the context for the subsequent analysis and helps in determining the potential failure modes and their effects. Once completed, you will have a clear understanding of the system to be analyzed and can proceed to the next task.
Establish the team responsible for the FMEA
In this task, you need to establish the team that will be responsible for conducting the Failure Mode and Effects Analysis (FMEA). The team should consist of individuals from different departments or areas of expertise to ensure a comprehensive analysis. The team will work together throughout the FMEA process, identifying and assessing potential failure modes and their effects. By the end of this task, the team should be formed, and roles and responsibilities should be clearly defined.
Identify potential failure modes
In this task, you need to identify the potential failure modes that could occur in the system being analyzed. Failure modes are the specific ways in which a system or its components may fail to meet the desired performance or functional requirements. By identifying these failure modes, you can understand the risks associated with them and prioritize further analysis and mitigations. Think about various scenarios and potential points of failure. Once completed, you will have a comprehensive list of potential failure modes.
Identify potential effects of each failure mode
In this task, you need to identify the potential effects of each failure mode that was identified in the previous task. The effects refer to the consequences or impacts that would result from the occurrence of a specific failure mode. By understanding these effects, you can assess the severity and prioritize further analysis and mitigations. Consider both direct and indirect effects on the system, operations, and stakeholders. Once completed, you will have a comprehensive list of potential effects for each failure mode.
Determine the severity ranking of each failure mode
In this task, you need to determine the severity ranking of each failure mode that was identified in the previous tasks. The severity ranking indicates the potential impact of a failure mode on the system, operations, and stakeholders. Consider the consequences, safety implications, and criticality of each failure mode. By ranking the severity, you can prioritize further analysis and mitigations. Once completed, you will have a severity ranking assigned to each failure mode.
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1. Negligible
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2. Minor
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3. Moderate
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4. Major
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5. Catastrophic
Approval: Severity Ranking
Will be submitted for approval:
Determine the severity ranking of each failure mode
Will be submitted
Identify potential root causes of each failure mode
In this task, you need to identify the potential root causes of each failure mode that was identified earlier. Root causes are the underlying factors or conditions that contribute to the occurrence of a failure mode. By identifying these root causes, you can understand the reasons behind the failure modes and develop appropriate mitigations. Think about design flaws, process inefficiencies, human errors, or external factors. Once completed, you will have a comprehensive list of potential root causes for each failure mode.
Determine the occurrence ranking for each root cause
In this task, you need to determine the occurrence ranking for each root cause identified in the previous task. The occurrence ranking indicates the likelihood or frequency of each root cause leading to the occurrence of its associated failure mode. Consider historical data, expert opinions, or any other relevant information to assess the occurrence. By ranking the occurrence, you can prioritize further analysis and mitigations. Once completed, you will have an occurrence ranking assigned to each root cause.
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1. Rare
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2. Unlikely
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3. Occasional
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4. Frequent
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5. Very Frequent
Approval: Occurrence Ranking
Will be submitted for approval:
Determine the occurrence ranking for each root cause
Will be submitted
Identify existing process controls
In this task, you need to identify the existing process controls that are currently in place to prevent or detect the occurrence of failure modes. Process controls refer to the measures, procedures, or systems that are designed to prevent or detect failures and mitigate their effects. By identifying these controls, you can assess their effectiveness and determine if any additional controls are required. Think about inspections, testing, monitoring, or quality assurance processes. Once completed, you will have a list of existing process controls.
Determine the detection ranking for each control
In this task, you need to determine the detection ranking for each control identified in the previous task. The detection ranking indicates the effectiveness of each control in detecting the occurrence of failure modes or their effects. Consider the reliability, frequency, and accuracy of each control in detecting failures. By ranking the detection, you can prioritize further analysis and improvements. Once completed, you will have a detection ranking assigned to each control.
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1. Very High
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2. High
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3. Moderate
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4. Low
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5. Very Low
Calculate the risk priority number for each failure mode
In this task, you need to calculate the Risk Priority Number (RPN) for each failure mode. The RPN is a numerical value used to prioritize failure modes based on their severity, occurrence, and detection rankings. Multiply the severity, occurrence, and detection rankings for each failure mode to obtain the RPN. The higher the RPN, the higher the priority for further analysis and mitigations. Once completed, you will have the RPN calculated for each failure mode.
Evaluate the need for further action based on RPN
In this task, you need to evaluate the need for further action based on the Risk Priority Number (RPN) calculated in the previous task. Consider the established thresholds or criteria for prioritizing actions based on the RPN values. Determine if further analysis, mitigations, or other actions are required for the failure modes with high RPN values. By evaluating the need for further action, you can prioritize resources and efforts effectively. Once completed, you will have a clear understanding of the required actions based on the RPN.
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Yes
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No
Approval: Action Plan
Will be submitted for approval:
Evaluate the need for further action based on RPN
Will be submitted
Implement the action plan
In this task, you need to implement the action plan developed to address the failure modes requiring further action. The action plan should include specific steps, responsibilities, and timelines for implementing the identified mitigations or improvements. Ensure clear communication, coordination, and monitoring of the action plan to achieve the desired outcomes. By implementing the action plan, you can reduce the risk of failures and improve the overall performance of the system. Once completed, the action plan should be underway.
Review the effectiveness of the action
In this task, you need to review and assess the effectiveness of the actions implemented as part of the previous task. Determine if the implemented actions have effectively mitigated the identified failure modes and improved the overall performance of the system. Consider qualitative and quantitative measures, feedback, and performance indicators. By reviewing the effectiveness, you can evaluate the need for further adjustments or continuous improvement efforts. Once completed, you will have an assessment of the action's effectiveness.
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Highly Effective
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Effective
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Partially Effective
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Ineffective
Approval: Effectiveness Review
Will be submitted for approval:
Implement the action plan
Will be submitted
Update the FMEA as necessary
In this task, you need to update the Failure Mode and Effects Analysis (FMEA) based on the findings and outcomes of the previous tasks. Incorporate the identified failure modes, effects, root causes, controls, rankings, and actions into the FMEA document or record. Ensure that the FMEA reflects the most up-to-date analysis and information. By updating the FMEA, you can maintain an accurate and comprehensive record of the system's failure modes and their mitigations. Once completed, the FMEA should be revised and updated.
Document the FMEA process and results
In this task, you need to document the Failure Mode and Effects Analysis (FMEA) process and its results. Create a comprehensive report or document that outlines the steps, findings, analyses, rankings, actions, and recommendations from the FMEA. This documentation will serve as a reference and guide for future analysis, decision-making, and improvement efforts. Ensure clarity, accuracy, and completeness in documenting the FMEA. Once completed, the FMEA process and results should be documented for future reference.
