Explore our comprehensive FMEA Risk Assessment Template- an intuitive workflow for identifying, rating, and mitigating potential system failures effectively.
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Define the scope of the FMEA risk assessment
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Identify team members for the process and their roles
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Review relevant documentation on the process/system/product to be analyzed
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Identify and list potential failure modes
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List potential effects for each identified failure mode
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Rate each effect on a scale of severity
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Approval: Ratings of Severity
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Identify potential causes for each failure mode
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Rate each cause on a scale of occurrence
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Approval: Ratings of Occurrence
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Identify existing controls and rate their detection level
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Calculate risk priority numbers (RPN) for each failure mode
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Prioritize the failure modes based on RPN
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Develop recommendation and actions plans
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Assign responsible person for each action plan
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Approval: Action Plans and Responsible Persons
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Implement action plans and monitor results
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Update FMEA as necessary based on monitoring results
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Document and communicate FMEA results and action plan to relevant stakeholders
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Approval: Final FMEA Report
Define the scope of the FMEA risk assessment
Clearly define the scope of the FMEA risk assessment by identifying the specific process/system/product to be analyzed. This task sets the foundation for the rest of the assessment, ensuring that all team members have a clear understanding of what is included and what is not. Consider the impact of the process/system/product on the overall organization and any potential risks associated with it. Are there any known limitations or constraints that should be taken into account?
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High
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Medium
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Low
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Budget constraints
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Resource limitations
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Time constraints
Identify team members for the process and their roles
Identify the team members who will be involved in the FMEA risk assessment and define their roles and responsibilities. Consider including individuals with a diverse range of expertise and perspectives to ensure a comprehensive analysis. Clearly define the expectations and communication channels for each team member to promote collaboration and efficiency. Are there any specific qualifications or expertise required for the team members?
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Quality Assurance
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Engineering
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Operations
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Management
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None
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Basic knowledge
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Advanced knowledge
Review relevant documentation on the process/system/product to be analyzed
Before diving into the assessment, it is important to gather and review relevant documentation related to the process/system/product being analyzed. This may include manuals, procedures, specifications, or any other relevant information. This step will provide a solid foundation of knowledge and help identify potential areas of focus for the assessment.
Identify and list potential failure modes
Identify and list all potential failure modes associated with the process/system/product being analyzed. Failure modes are specific ways in which a process/system/product can fail. This step allows the team to create a comprehensive list of potential risks to be assessed.
List potential effects for each identified failure mode
For each identified failure mode, list the potential effects that could occur if the failure mode were to happen. Effects are the consequences or impacts of a failure mode. Comprehensive identification of potential effects is essential for accurate risk assessment.
Rate each effect on a scale of severity
Assign a severity rating to each effect based on the potential impact it would have on the process/system/product. Severity rating helps prioritize risks and determine their significance. Rate each effect on a scale of severity, considering factors such as safety, financial impact, customer satisfaction, and regulatory compliance.
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Approval: Ratings of Severity
Will be submitted for approval:
Rate each effect on a scale of severity
Will be submitted
Identify potential causes for each failure mode
For each failure mode, identify the potential causes that could lead to its occurrence. Causes are the root factors or events that can trigger a failure mode. Identifying potential causes helps in understanding and addressing the underlying reasons for failure modes.
Rate each cause on a scale of occurrence
Assign an occurrence rating to each cause based on the likelihood of it occurring and leading to a failure mode. Occurrence rating helps in assessing the probability of failure modes. Rate each cause on a scale of occurrence, considering historical data, expert opinions, and other available information.
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Approval: Ratings of Occurrence
Will be submitted for approval:
Rate each cause on a scale of occurrence
Will be submitted
Identify existing controls and rate their detection level
Identify any existing controls or measures that are in place to detect or prevent the identified failure modes. Controls can be processes, procedures, equipment, or any other preventive measures. Rate the detection level of each control, which represents its effectiveness in detecting or preventing the failure mode.
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Calculate risk priority numbers (RPN) for each failure mode
Calculate the Risk Priority Number (RPN) for each failure mode. RPN is a product of severity, occurrence, and detection ratings and helps in prioritizing risks. Multiply the ratings assigned in previous steps to calculate the RPN for each failure mode.
Prioritize the failure modes based on RPN
Based on the calculated RPNs, prioritize the failure modes. Sort the failure modes in descending order of their RPNs to identify the most critical risks. This prioritization will help in focusing efforts and resources on addressing the highest impact risks first.
Develop recommendation and actions plans
Based on the prioritized failure modes, develop recommendations and action plans. Recommendations should include proposed actions to reduce the risk associated with each failure mode. Action plans should outline specific steps, responsibilities, and timelines for implementing the recommendations.
Assign responsible person for each action plan
Assign a responsible person for each action plan. Clearly identify who will be accountable for implementing and monitoring the recommended actions. This ensures clarity and accountability within the team.
Approval: Action Plans and Responsible Persons
Will be submitted for approval:
Develop recommendation and actions plans
Will be submitted
Assign responsible person for each action plan
Will be submitted
Implement action plans and monitor results
Implement the action plans developed in the previous step and monitor the results. Ensure that the recommended actions are executed as planned and track the progress and effectiveness of each action. Regular monitoring and evaluation will help in identifying any deviations or areas for improvement.
Update FMEA as necessary based on monitoring results
Based on the monitoring results, update the FMEA risk assessment as necessary. Incorporate any new information or insights gained from the implementation and monitoring of the action plans. This step ensures that the FMEA remains up to date and reflects the current understanding of risks.
Document and communicate FMEA results and action plan to relevant stakeholders
Document the FMEA results and action plan in a clear and concise manner. Share the documented information with relevant stakeholders involved in the process/system/product being assessed. Effective communication ensures that all stakeholders are informed about the identified risks and the planned actions to mitigate them.
Approval: Final FMEA Report
Will be submitted for approval:
Document and communicate FMEA results and action plan to relevant stakeholders
