FMEA

Failure Mode and Effect Analysis

Purpose:

• Track down and remove special causes of variation.
• Verify that controls for key and critical product characteristics are addressed in the process.
• To identify the unacceptable process outputs that can be created at each process step, the causes, the severity and the method of control to prevent or detect the potential unacceptable process outputs.
• To identify the possible ways in which non-conformities can occur in a manufacturing process, and recommend actions to prevent the nonconformities and/or detect them before the non-conforming parts are shipped to the customer.

Process FMEA Inputs:

• DFMEA (If available)
• Customer Returns, Complaints, Corrective Actions
• Internal NR Data
• Characteristic Matrix
• Process Map
• Final Inspection Reject Data
• Process Capability Studies (Cpk)
• MSA Studies

Key Analysis Considerations:

• Characteristic Accountability

• Self QC

• Product Handling

• Administrative Errors

• Assembly Errors

• Part Marking Errors

• F.O.D.

• Packing

• Shipping Damage

• Customer Perception

Brainstorming tools that will assist with developing a process FMEA:

• Ishikawa Diagrams (Fish Bone)

• Five Why’s