Definition of Design Failure Mode and Effect Analysis (DFMEA):
The application of the Failure Mode and Effects Analysis (FMEA) method specifically to product/service design.
There are 11 steps to complete DFMEA:
- Design Review – Use the product/service design drawings or documents to identify each component and its relation with other components of product/service
- Brainstorm potential failure modes
- List potential failure modes
- List potential effects of failure modes
- Assign the severity ranking which should be based on consequences of failure (1 to 10) (Threat to human life, accident or safety issue is scored 10)
- Assign the occurance ranking (1 to 10)
- Assign detection ranking based on the chance of detection prior to failure (1 to 10) (Easy for detection gets less score – 1, difficult to detect should be assigend higher score)
- Calculate the SOD (Severity x Occurrence x Detection) number or risk priority number (RPN)
- Develop action plan to reduce vital RPNs (Above set baseline)
- Implement the improvements identified
- Calculate RPN again based on improvements. Do mistake proofing.
