Failure Mode & Effect Analysis (FMEA)


The purpose for FMEA is to identify the product’s function and process steps along with their respective potential failure mode, effect and causes. And FEMA is generally refer to product function or manufacturing process steps to perform the risk evaluation.

In addition, FMEA also evaluates the sufficency of existing prevention and detection actions. If it is insufficient, then recommended actions can be implemented.

The following list summarize what FMEA emphasize on for product development: 

FMEA shall be applied based on the following conditions:

Before evaluting the Design & Process FMEA, 5T’s shall be considered (see below):

What’s the purpose/target of executing FMEA?

When’s the due date to complete?

Who are the required stakeholders?

What are the required work needs to be completed?

How does the team perform evaluation or analysis?

Based on APQP’s timeline, the design and process FMEA’s completion shall refer to the following description:

FMEA Completion with APQP Timeline

Before breaking down the differences between design and process FMEA, the following diagram will show the general flow of how FMEA is formulated with these 7 steps:

FMEA Steps

FMEA Planning & Preparation

Generally in the FMEA’s planning & preparation phase, the purpose is to define the scope for the respective FMEA. In addition, confirmation and planning of objects along with scope boundaries shall bode well for the structural analysis within the product. 

The following questions can help to define the scope of DFMEA

For DFMEA, lesson learnt from previous product development can be applied to define the proper scope boundary along with structural analysis. But for PFMEA, more concrete input can be considered for the scope boundaries.

The following items can be considered to confirm the PFMEA boundary scope:

FMEA Structural Analysis

The purpose for structural analysis is to break down design into levels such as system, sub-system, component level and technical risk analysis.

In addition, the design structural analysis’ objectives are:

The following items can be considered to confirm the process FMEA boundary scope:

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