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

FAILURE MODE & EFFECT ANALYSIS 4 th 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. New designs, new technology, or new process. The scope of the FMEA is the complete design, technology or process. CASE 1 Modifications to existing design or process. The scope of the FMEA should focus on the modification to design process, possible interactions due to the modification and field history. CASE 2 Use of existing design or process in a new environment, location, or application. The scope of the FMEA is the impact of the new environment or location on the existing design or process. CASE 3

An FMEA is carried out as a team activity, except in a small company where limited people may complete the analysis. EXPERTS IN FIELD FMEA SPECIALIST PROCESS OWNER 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. the Cause of the Failure Mode from happening or reduce its Occurrence. PREVENT the Cause of the Failure Mode (and hence prevent from happening) with such detection having a pre-determined Reaction Plan DETECT the Failure Mode (and Prevent it from being processed further) with such detection having a pre-determined Reaction Plan DETECT

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 Website / Software innovator.phphttp:// innovator.php Failure Mode & Effect Analysis Training material e-Examination & Certification