FMEA is a systematic method for identifying and preventing potential problems or failures in a design, product or process. It was developed in the 1960s for the aerospace industry. The key purposes of FMEA are to identify potential failure modes and their causes, eliminate or reduce risks, and document the analysis. FMEA is applied in both design processes and operational processes to improve quality by minimizing failures. Common mistakes include applying FMEA too late, having the wrong team members, and overdependence on numerical ratings.

1. FMEA

2. Introduction to FMEA
• Failure Mode and Effects Analysis, FMEA is:
• A systematic method of identifying and
investigating potential design or process
weaknesses.
• A means to evaluate and manage product risks.
• A means of evolving organizational knowledge.
• Developed in the aerospace industry in the mid
1960’s
• Also sometimes referred to as Failure Mode Effect
and Criticality Analysis, FMECA

3. Purpose
• Recognise and evaluate the potential failure
modes and causes associated with the design
andmanufacture of a product or design and
operation of any process.
• Identify actions which could eliminate or
reduce the chance of the potential failure
occurring.
• Document the analysis and changes made.

4. Application of FMEA in Six Sigma
In Design for Six Sigma - (Design FMEA) :
• to identify potential failure modes
• to identify potential causes of failure
• to eliminate/minimise the potential failure
modes within the Design process

5. In Transactional/Operational Six Sigma (Process
FMEA) :
• to analyse the existing processes (identify
possible x’s)
• to improve the process (elimination/reduction
of failure modes)
• to select new process alternatives
• to develop control plans

7. 10 Keys To FMEA Success
• Support by top & middle management
• Motivated team members
• Cross functional representation on the team
• Treat as “before the event” not “after the fact”
• Generate company specific rating scales
• Treat as a living document-reflect latest revisions
• Execute recommended actions
• Integration into your development process
• Generate & use a library of generic FMEA’s
• Follow the spirit, not the form

8. Common Mistakes
• Applied too late
• Poor team working, wrong team members or
no team
• Over dependence upon the numbers
• Inconsistency in numbers
• Solving all problems in meetings

9. Application of FMEA in DMAIC
• Analyse: To analyse the existing processes and
identify possible x’s (causes of failure)
• Improve: To improve the process
(elimination/reduction of failure modes)
To select new process alternatives
• Control: To develop control plans
It is only necessary to conduct PFMEA on the
modified/changed areas of the process