How to conduct FMEA for a product or process?

What is FMEA?

An FMEA can be described as a schematic group of activities to :

• Identify the potential failure modes for a product or process.
• Assess the risk (effects) associated with those failure.
• Rank failure in term of importance.
• Identify and carry out corrective actions to address the most serious concerns.

In FMEA each individual failure is considered as an independent occurrence with no relation to other failures in the system.

Basic steps for conducting an FMEA:

1. The objectives and scope of the FMEA are defined by the team leader.
2. A cross functional analysis team of 4 to 7 people is assembled. The team do brainstorming for each activity.
3. The team then gather and prepare information for analysis. The team team first understand fully what the product / process must do to satisfy the customer. It also review relevant information such as similar FMEA done in the past and feedback already in the market.
4. The team then conduct the FMEA. Do this activity as per FMEA Procedure.
5. The next step is to develop recommendations. This includes prioritizing and assigning corrective actions.
6. Finally analysis and recommendations are documented.
7. The team then presents for approval.
8. The process owner implements the recommendations.
9. Finally the implementation of the recommendation is tracked.

The early and consistent use of FMEA in the design process allows the engineer to design out failures and produce reliable, safe and customer satisfying product.

FMEA identify potential failure mode for a product or process ,assesses the risk associated with those failure mode and carries out corrective actions to address the most serious concerns.

Potential failure effects are what the next user of product or process would experience.

Severity (S) is the seriousness of the effect of the failure.

Occurence (O) is the likelihood that a specific cause will occur during the design life of the product / process.

Detection (D) is the probabilty that current control will detect the potential cause or subsequent failure.

Examples of FMEA:

Stamping Process PFMEA: