FMEA Example

FMEA Example

Problem Statement

Create an FMEA analysis for implementation of SPC charts in a work area. Some example of potential failures are shown below. However, you will need to brainstorm with your team and fill in the missing information.

Typical Failure Modes

Forget to collect data

Collect the wrong data

Wrong data entered on the chart

Chart not updated

Incorrect interpretation of the chart

Recommendations from the SPC chart not followed

How to perform analysis

Step 1: Open Sigma Magic
  1. Click on the Sigma Magic button on the Excel toolbar.
  2. Click on the New button to create a new project.
Step 2: Add the analysis template
  1. Click on the Tool Wizard to add the analysis template.
  2. Click on Project and then FMEA.


Step 3: Specify analysis options
A new worksheet will be added to your workbook. Analysis Setup will be automatically opened, in the setup tab specify the following details.



Click on the Checklist button, you will see the following dialog box. Ensure that the items mentioned in checklist should be marked.



If you need to make changes to the charts, specify the optional settings in the Charts tab.

 Labels:

  • Add a title for the chart.
  • Label the X-axis and Y-axis appropriately.

Appearance:

  • Adjust colors, font sizes, or other visual elements as needed.
  • Enable/disable gridlines or background shading.


Step 4: Enter the details in worksheet
Click Create, the worksheet will created and then enter all the details. A sample is provided below:



Click on the Analysis Setip and then click Verify tab to ensure all the inputs are okay and shown in a green checkmark.



Step 5: Generate analysis result
Click Analyze and then click Compute Outputs to get the final results



Interpretating Results

  1. All six failure modes are categorized under "High Priority (H)" in the risk analysis, indicating significant risks that need immediate attention.
  2. The major causes of failure include busy operators, lack of experience, incorrect priorities, and no emphasis from senior management, indicating process inefficiencies and a need for better training and leadership involvement.
  3. Some failure modes, such as "Collecting the wrong data" and "Incorrect interpretation of the chart," have no detection controls (DC = 10). This means there are no safeguards in place to catch these issues before they cause damage.
  4. Several failure modes have low prevention control scores (PC = 5-7), suggesting weak preventive measures. Issues like data collection errors and incorrect decisions need stronger preventive mechanisms such as automated data validation and stricter quality control measures.
  5. Many failures are associated with Statistical Process Control (SPC) charts, such as not updating charts, incorrect recommendations, and misinterpretation of charts. This suggests a lack of proper understanding and adherence to SPC processes.
  6. Prevention controls like weekly checks and monthly checks are in place but might not be sufficient, as errors are still occurring. Strengthening real-time monitoring and validation mechanisms is necessary.
  7. The failure modes show that lack of experience and training is a significant contributing factor. Operators need better training, clear documentation, and standardized procedures to reduce human errors.
  8. Multiple failure modes highlight a lack of emphasis from senior management, showing a need for stronger leadership and accountability in ensuring process adherence.
  9. Since many issues arise from wrong decisions and misinterpretations, standardizing data entry, chart updates, and decision-making guidelines will help mitigate errors.
  10. Given the recurring issues with manual data collection and updates, introducing automated SPC chart updates, digital validation, and AI-driven analytics can significantly reduce errors and improve efficiency.


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