Failure Mode and Effects Analysis (FMEA) is a useful tool for identifying and mitigating potential risks in a process or product. The process of conducting an FMEA involves identifying potential failure modes, determining the causes of those failure modes, and assessing the potential effects of those failures. In this article, we will discuss how to conduct an FMEA, including documenting and reporting FMEA results, following up on FMEA findings, and implementing improvements.

Conducting an FMEA

Step 1: Define the scope of the FMEA

The first step in conducting an FMEA is to define the scope of the analysis. This involves identifying the process or product to be analyzed, the boundaries of the analysis, and the team members who will be involved in the analysis. The scope of the analysis should be defined in clear terms, and the team members should be identified based on their expertise in the area being analyzed.

Step 2: Identify potential failure modes

The next step is to identify the potential failure modes for each step of the process or component of the product being analyzed. This involves analyzing the ways in which the process or component could fail and identifying the causes of the failure.

To identify potential failure modes, the team should brainstorm and generate a list of potential failure modes. They can use past experience, failure analysis, process mapping, and other techniques to identify potential failure modes. Each potential failure mode should be recorded in a worksheet, along with a brief description of the failure mode.

Step 3: Determine the severity of the failure modes

The team then assesses the severity of each potential failure mode. This involves evaluating the potential impact of the failure on safety, environment, production, and customer satisfaction. Severity is usually rated on a scale of 1 to 10, with 10 being the most severe.

To determine the severity of a failure mode, the team can ask questions such as:

  • What is the potential impact of the failure on safety?
  • What is the potential impact of the failure on the environment?
  • What is the potential impact of the failure on production?
  • What is the potential impact of the failure on customer satisfaction?

The severity rating for each potential failure mode should be recorded in the worksheet.

Step 4: Determine the likelihood of occurrence of the failure modes

The team then assesses the likelihood of each potential failure mode occurring. This involves evaluating the probability of the failure occurring. Likelihood is usually rated on a scale of 1 to 10, with 10 being the most likely.

To determine the likelihood of a failure mode occurring, the team can ask questions such as:

  • How often has this failure mode occurred in the past?
  • What are the potential causes of this failure mode?
  • How effective are the current controls in preventing this failure mode?

The likelihood rating for each potential failure mode should be recorded in the worksheet.

Step 5: Determine the detectability of the failure modes

The team then assesses the detectability of each potential failure mode. This involves evaluating the probability of the failure being detected. Detectability is usually rated on a scale of 1 to 10, with 10 being the most detectable.

To determine the detectability of a failure mode, the team can ask questions such as:

  • How effective are the current inspection and testing methods in detecting this failure mode?
  • Are there any warning signs or indicators that can be used to detect this failure mode?

The detectability rating for each potential failure mode should be recorded in the worksheet.

Step 6: Calculate the Risk Priority Number (RPN)

The team then calculates the Risk Priority Number (RPN) for each potential failure mode. The RPN is calculated by multiplying the severity, likelihood of occurrence, and detectability of the failure mode. The RPN score can range from 1 to 1000, with a higher score indicating a higher risk.

The RPN helps the team to prioritize improvement opportunities based on the highest risk areas. The team can focus their efforts on the failure modes with the highest RPN scores to develop improvement actions.

Step 7: Prioritize improvement opportunities

The team then prioritizes improvement opportunities based on the RPN scores. The potential failure modes with the highest RPN scores are given the highest priority for improvement. The team should focus on the potential failure modes with the highest RPN scores and develop improvement actions to reduce the likelihood of occurrence or severity of the failure.

Documenting and Reporting FMEA Results

Once the team has completed the FMEA, the results should be documented and reported. This helps to communicate the findings to stakeholders, track improvement actions, and provide a record for future reference. The documentation should include the following:

  1. FMEA worksheet: The FMEA worksheet should include the list of potential failure modes, severity, likelihood of occurrence, detectability, and RPN score.
  2. Improvement actions: The improvement actions should be documented with details on who is responsible, what actions will be taken, and the timeline for completion.
  3. Follow-up plan: The follow-up plan should be documented with details on how the team will track the progress of improvement actions, when the follow-up will be conducted, and who will be responsible for the follow-up.

Following up on FMEA Findings

Following up on FMEA findings is critical to ensure that the improvement actions are implemented and effective. The following steps can help to ensure effective follow-up:

  1. Assign responsibility: Each improvement action should be assigned to a specific team member who will be responsible for implementing the action.
  2. Set timelines: Each improvement action should have a timeline for completion. The team member responsible should be given a deadline for completing the action.
  3. Track progress: The progress of improvement actions should be tracked regularly to ensure that they are on schedule. The team should use a tracking system to monitor progress.
  4. Conduct follow-up: The team should conduct a follow-up FMEA to determine if the improvement actions have been effective. The follow-up FMEA should be conducted after the improvement actions have been implemented.

Implementing Improvements

The final step in the FMEA process is to implement the improvement actions. This involves taking the necessary steps to reduce the likelihood of occurrence or severity of the potential failure modes. The team should take the following steps to implement improvements:

  1. Develop an action plan: The team should develop an action plan for implementing the improvement actions. The action plan should include specific tasks, timelines, and responsibilities for each team member.
  2. Communicate the plan: The action plan should be communicated to all team members and stakeholders. The team should ensure that everyone is aware of the plan and their responsibilities.
  3. Implement the plan: The team should implement the improvement actions according to the action plan. The team member responsible for each action should ensure that the action is completed on time and to the required standard.
  4. Monitor progress: The progress of the improvement actions should be monitored regularly. The team should use a tracking system to monitor progress and ensure that the actions are completed on time.
  5. Conduct a follow-up FMEA: The team should conduct a follow-up FMEA to determine if the improvement actions have been effective. The follow-up FMEA should be conducted after the improvement actions have been implemented.

Conclusion

Conducting an FMEA is a critical step in identifying and mitigating potential risks in a process or product. The FMEA process involves identifying potential failure modes, determining the causes of those failure modes, and assessing the potential effects of those failures. The FMEA results should be documented and reported, improvement actions prioritized, and follow-up conducted to ensure that the improvement actions are implemented and effective. Implementing improvements is the final step in the FMEA process, which involves taking the necessary steps to reduce the likelihood of occurrence or severity of the potential failure modes. The team should develop an action plan, communicate the plan, implement the plan, monitor progress, and conduct a follow-up FMEA to ensure that the improvement actions are effective.

In summary, FMEA is a powerful tool for identifying and mitigating potential risks in a process or product. By following the steps outlined in this article, organizations can conduct an FMEA effectively and efficiently, document and report FMEA results, follow-up on FMEA findings, and implement improvements. FMEA can help organizations to improve product and process design, reduce costs, and improve customer satisfaction. Organizations that use FMEA as part of their quality management strategy can enhance their competitiveness, by improving quality, reducing costs, and improving customer satisfaction.