PTY (Ltd) Reg No: 2007/019351/07

FAILURE MODE & EFFECT ANALYSIS4th Edition (Including Control Plans)

WHAT IS AN FMEA?

FMEA is an analytical technique used to ensure that potential problems have been considered and addressed.

“It is complementary to the process of defining what a design or process must do to satisfy the customer.”

Benefits of FMEA

Ensuring effective multidisciplinary use of resources for risk assessment.

Prioritizing process improvements based on and risk and customer

satisfaction.

Effective management reporting, enabling return on investment of

resources.

Motivating action to be taken to prevent high failure costs and throughout

the life of the process.

Completed FMEA’s provide a good foundation for problem solving.

An FMEA is carried out as a team activity, except in a small company where limited people may complete the analysis.

Sponsor

Member of Senior Management approves resources supports team

ensures efforts are in line with Management Objectives

SPONSOR

POTENTIAL FAILURE MODE

E

D

O

M

It is the Manner in which a component, subsystem, system or process could potentially fail to meet or

deliver the intended function described in the item/function column.

POTENTIAL EFFECT(S) OF FAILURE

T

C

E

F

F

E

Describe the effects of the failure in terms of what the customer might notice or experience, remembering that the customer may be an internal customer as well as the ultimate end user. State clearly if the failure mode could impact safety or cause non-compliance to regulations.

E

S

U

A

C

POTENTIAL CAUSE(S) / FAILURE

All the CAUSES can trigger the FAILURE MODE, the ultimate result of which is the EFFECT, therefore ALL the

CAUSES are equally serious and do share the same severity ranking number..

Controls are established during initial Process planning.

RISK PRIORITY

NUMBER

N

P

R

This number is used to help identify the most serious risks, leading to corrective action.

The primary objective of recommended actions is to reduce risks and increase customer satisfaction by improving the design/process.

PTY (Ltd) Reg No: 2007/019351/07