Failure Mode Effects Analysis (FMEA) in Medical Device Manufacturing
INTRODUCTION
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 team to identify solutions to these risks.
COURSE DELIVERY
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 OBJECTIVES
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.
COURSE OUTLINE
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 team to identify solutions to these risks.
COURSE DELIVERY
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 OBJECTIVES
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.
COURSE OUTLINE
- 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
TARGET AUDIENCE
Anyone who wants to learn a proactive method to manage and to continuously improve work processes, and to improve overall work effectiveness and efficiency
PRE-REQUISITES
There is no prerequisite for this course.
DURATION
Two (2) full days
PAYMENT
Payment is required before/ on training date. Please choose from below options.
Option 1 : Direct Bank-in or via E-Banking upon receipt of Invoice
Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice.
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
Please email us (admin@medsociate.com) the bank-in slip / remittance slip once the payment is made.
For Government Sector
A Local Order (LO) or letter of approval to participate must be presented before the training.
Option 2 : Direct Online Payment
You can choose to make payment via Paypal upon receipt of invoice. When making payment, in the email section, please key in our Paypal Account : admin@medsociate.com
SUBSTITUTION
Substitution is allowed for a registered participant. No refund will be made for cancellation.
CANCELLATION
Medsociate Sdn Bhd (AMMI Authorised Training Provider) 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 if the cancellation is made by training provider. Cancellation of attendance and refund will not be entertained as all bookings would have been reserved and confirmed.
CONTACT
For enquiries, please email to admin@medsociate.com.
Medsociate Sdn Bhd
(HRDF Approved Training Provider - Registration No. 4195)
(AMMI Authorised Training Provider and Secretariat)
Tel: +6010 4040 662 Fax: +603 2178 4347
Anyone who wants to learn a proactive method to manage and to continuously improve work processes, and to improve overall work effectiveness and efficiency
PRE-REQUISITES
There is no prerequisite for this course.
DURATION
Two (2) full days
PAYMENT
Payment is required before/ on training date. Please choose from below options.
Option 1 : Direct Bank-in or via E-Banking upon receipt of Invoice
Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice.
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
Please email us (admin@medsociate.com) the bank-in slip / remittance slip once the payment is made.
For Government Sector
A Local Order (LO) or letter of approval to participate must be presented before the training.
Option 2 : Direct Online Payment
You can choose to make payment via Paypal upon receipt of invoice. When making payment, in the email section, please key in our Paypal Account : admin@medsociate.com
SUBSTITUTION
Substitution is allowed for a registered participant. No refund will be made for cancellation.
CANCELLATION
Medsociate Sdn Bhd (AMMI Authorised Training Provider) 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 if the cancellation is made by training provider. Cancellation of attendance and refund will not be entertained as all bookings would have been reserved and confirmed.
CONTACT
For enquiries, please email to admin@medsociate.com.
Medsociate Sdn Bhd
(HRDF Approved Training Provider - Registration No. 4195)
(AMMI Authorised Training Provider and Secretariat)
Tel: +6010 4040 662 Fax: +603 2178 4347