FMEA in Medical Device Manufacturing

SOCSO Course Category:

SOCSO Course Code:

Course Title:
Failure Mode Effects Analysis (FMEA) in Medical Device Manufacturing

2 Days


Target Group:

Anyone who wants to learn a proactive method to manage and to continuously improve work processes, and to improve overall work effectiveness and efficiency


Target Industry:

Medical Device Manufacturing Industry



Certificate of Attendance in Failure Mode Effects Analysis (FMEA) in Medical Device Manufacturing by the Association of Malaysian Medical Industries


Course Objectives:

This course is designed for participants who are interested 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 a team to identify solutions to these risks.


Methods/ Methodology:

  • Lecture
  • Case Studies
  • Pre-Test & Post-Test

The course will be delivered in a Workshop environment, adopting the Action Learning Methodology to increase the rate of transferring from knowledge acquisition to skill application. The emphasis is on learning by doing, and not learning by listening. Participants will experience a simulated process at the beginning of the course. Progressively, they will learn and apply the tools to improve the simulated process.


Course Content:

  • Types of FMEA: Design and Process FMEA
  • System and SIPOC diagrams
  • Traditional and updated FMEA template
  • Key components of FMEA: Rating scales, Risk Priority Number (RPN) & CA
  • Planning for FMEA
  • Executing Process FMEA
  • Executing Design FMEA
  • Evaluate solutions
  • Monitor and continuously improve the solutions

Learning Outcomes:

This course will enable you to differentiate between Design and Process FMEA, practise live Process and Design FMEA in class, assess risk in a systematic manner, quantify and prioritize risks with Criticality Analysis (CA), improve process within own department (point kaizen), contribute to cross-functional process improvement (flow-kaizen)  and map your current “As Is” business process.

It will also enable you to engage staff through systematic analysis and improvement, while generating solutions to eliminate or reduce failure risks – all of which will lead to improved cost, delivery and quality.