1. Define the Scope

Identify the product, process, or system to be analyzed.

Determine the boundaries of the FMEA study.

Assemble a cross-functional team with relevant expertise.

2. Gather Information

Collect existing documentation (design specs, process flow diagrams, etc.).

Review previous FMEAs or related analyses if available.

Understand customer requirements and expectations.

3. Identify Failure Modes

Brainstorm potential failure modes for each component or step.

Consider how each component can fail (e.g., mechanical failure, human error).

Document the potential failure modes clearly.

Here are some additional steps that could be included in the "Identify Failure Modes" section of the FMEA checklist

Review historical data and past FMEAs for similar components or systems to identify previously encountered failure modes

Consult with cross-functional teams (e.g., engineering, manufacturing, quality assurance) to gather diverse perspectives on potential failure modes

Use fault tree analysis or cause-and-effect diagrams to systematically explore and identify potential failure modes

Conduct a failure mode and effects brainstorming session with stakeholders to encourage creative thinking and comprehensive coverage

Analyze design specifications and requirements to identify areas where failures could occur due to non-compliance or misinterpretation

Assess environmental factors that could contribute to failure modes, such as temperature, humidity, or exposure to chemicals

Consider user interactions and potential misuse scenarios that might lead to failures

Evaluate the lifecycle of the product or component to identify potential failure modes at different stages (e.g., production, operation, maintenance)

Prioritize the identified failure modes based on their likelihood of occurrence and potential impact on the system or process

These additional steps can help ensure a thorough examination of potential failure modes and enhance the overall effectiveness of the FMEA process

4. Determine Effects of Failures

Analyze the consequences of each failure mode on the system.

• Review each failure mode identified.
• Assess impact on system functionality.
• Evaluate potential downtime or disruption.
• Consider secondary effects on related systems.
• Prioritize based on severity of consequences.

Identify how each failure mode affects customer requirements.

• Determine customer expectations for performance.
• Analyze how failures may lead to dissatisfaction.
• Identify critical features impacted by failures.
• Assess potential financial impacts on customers.
• Document findings for stakeholder review.

Document the effects on performance, safety, and compliance.

• Record performance metrics affected by failures.
• Assess safety risks introduced by each failure mode.
• Evaluate compliance with industry regulations.
• Maintain clear documentation for audit purposes.
• Share findings with relevant teams for action.

5. Assess Severity

Rate the severity of each effect on a predetermined scale (e.g., 1 to 10).

Consider the impact on safety, customer satisfaction, and regulatory compliance.

Document the severity ratings for each failure mode.

6. Identify Causes of Failure

Determine the root causes of each failure mode.

Use techniques such as brainstorming, cause-and-effect diagrams, or the 5 Whys.

Document the causes for each identified failure mode.

7. Assess Occurrence

Rate the likelihood of each cause occurring on a predetermined scale.

Use historical data, expert judgment, or industry standards.

Document the occurrence ratings for each failure mode.

8. Identify Current Controls

Review existing controls or processes that detect or prevent failures.

Evaluate the effectiveness of these controls.

Document current controls for each failure mode.

9. Assess Detection

Rate the ability of current controls to detect the failure before it reaches the customer.

Use a predetermined scale for detection effectiveness.

Document detection ratings for each failure mode.

10. Calculate Risk Priority Number (RPN)

For each failure mode, calculate the RPN using the formula: RPN = Severity x Occurrence x Detection.

Document the RPN for each failure mode.

11. Prioritize Failure Modes

Rank failure modes based on their RPN.

Identify high-priority failure modes requiring immediate attention.

Document the prioritized list.

12. Develop Action Plans

For high-priority failure modes, develop action plans to mitigate risks.

Assign responsibilities and deadlines for each action item.

Document the action plans and follow-up procedures.

13. Implement Action Plans

Execute the action plans as per the established timelines.

Ensure team members are accountable for their assigned tasks.

Document the implementation process and any changes made.

14. Review and Update FMEA

Regularly review the FMEA as part of continuous improvement.

Update the FMEA based on new data, changes to the product/process, or lessons learned.

Ensure the FMEA remains a living document.

15. Communicate Results

Share the findings and action plans with relevant stakeholders.

Ensure that all team members understand their roles in risk management.

Document and maintain communication records for future reference.