FMEA in Medical Device Manufacturing

10-11 July 2019 at E&O Hotel, Penang, 9am-5pm


AMMI Member: RM 1,200 per pax
Non Member: RM 1,400 per pax

NORMAL COURSE FEES (from 16 June onwards)
AMMI Member: RM 1,400 per pax
Non Member: RM 1,600.00 per pax


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.



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.



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.



  • 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



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



There is no prerequisite for this course.



Mr LK Lim is a director of NexMU Sdn. Bhd. and a Certified Six Sigma Master Black Belt.  He is a professional engineer with a Bachelor of Science in Mechanical Engineering and a Master of Business Administration. He has over 20 years of working experience in Operations Management, Process, Quality System and Business Process Improvement in variety of industries including the medical device industry. He has worked with and at senior management, level to improve process efficiency, implement effective Lean manufacturing systems and improve profitability.


He has over 6 years of presenting experience with reputable universities such as the University of Melbourne in Australia and the University of Auckland in New Zealand. He coached and consulted for Motorola University’s clients which have embarked on the Lean Six Sigma Business Improvement Campaign. In addition to consulting, he has trained Six Sigma and Lean Green and Black Belts candidates in Australia, New Zealand, People Republic of China, India, Malaysia, Singapore, Indonesia and Thailand. He is currently also serving as an advisor to senior leadership for companies in a variety of industries, some of which are multinationals (MNC) and medical device manufacturing company.

All payment is due immediately upon receipt of invoice. Please note that a confirmation letter for HRDF submission will only be issued upon receipt of payment.

Option 1 :  Direct Bank-in or via E-Banking upon receipt of Invoice
An invoice will be sent to you within 3 working days upon your registration.  Please note that any Early Bird Discounts (for registration within the validity period) will be reflected in the invoice. Please email us ( the bank-in slip/remittance slip once the payment is made. A confirmation letter for your HRDF submission will be issued to you upon receipt of payment.

Please refer the following bank account details:

Beneficiary Name: Medsociate Sdn Bhd
Bank Account Number: 800 3930 348
Bank: CIMB Bank
Swift Code: CIBB MYKL 

For Government Sector – A Local Order (LO) or letter of approval to participate must be submitted before your registration can be confirmed. 

Option 2: Direct  Online Payment
You may choose to make direct online payment, via Paypal or your credit/ debit card. A tax invoice and confirmation letter will be sent to your email address within 3 working days, when you choose this option.

AMMI reserves the right to cancel or postpone any training or event but with due notice to the registered participants/company (s). Any payment made will be refunded in full if the cancellation is made by AMMI.  No shows and cancellations made by participants/ companies within the specified period will incur the specified costs as per below schedule.

Prior to Training Date Cancellation Charges
30 days or more  No charges
15-29 days 25% of training course fee 
8 – 14 days 50% of training course fee
0 – 7 days 100% of training course fee

Replacement of the participant is allowed at no additional cost if you are unable to attend. Please inform us of the replacement in writing at least 3 working days before the training date.



For enquiries, please email to
Tel: +6010 4040 662  Fax: +603 2178 4347