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