INTRODUCTION

FMECA is a proactive risk assessment, quality and cost improvement method. It is useful in pre-empting failure risks, and driving process improvement without having to deal with Statistical Tools. Participants will learn to systematically identify potential failure risks, quantify and prioritize these risks, and to work effectively in team to identify solutions to these risks.

COURSE OBJECTIVES

The course is design for the participants to:

• Differentiate between Design and Process FMECA.
• Assess risks in a systematic manner.
• Quantify and prioritize risks.
• Improve process within own department (point-kaizen).

• Contribute to cross functional process improvement (flow-kaizen).
• Engage staff through systematic analysis and improvement.

COURSE OUTLINE

• ISO 13485 and FMEA
• Overview of Change and Risks
• Introduction to FMECA
• FMECA Overview
• Failure Modes and Effects Analysis (FMEA)
• FMEA Terminologies, Tools and Method
• Criticality Analysis (CA)
• FMEA Key Success Factors
• Introduction to Process FMECA
• The Five (5) Phases of Conducting FMEA
• FMECA Tools.
• Application Examples of FMEA

DURATION

One (1) full day

TARGET AUDIENCE

This programme is designed for operations and design staff who wants to learn a proactive method to manage and to continuously improve work processes, and to improve overall work effectiveness and efficiency.