ISO 13485 ISO 9001 Risk Management Training and Workshops

Training Total Day & Time: 2 Days (9.00am to 5.00pm)

To explain the systematic approach of root cause analysis and FMEA method in the application of risk management process for organization to determine 3 categories of improvement actions that gear for significant improvement of the organization performance.

Day1	9am~1pm	Risk Management based on Failure Mode & Effect Analysis (FMEA). What is FMEA? Application of FMEA. Features of FMEA. Fish Bone method for root cause determination for weaknesses/ problems. Quantification (Probability of Occurrence, Severity and Detection). Existing controls. Determination/ planning and implementation of controls. Residue risk assessment/ evaluation on the effectiveness of planned implementation outcome.
	1pm~2pm	Lunch Break
	2pm~5pm	Workshop 1: Determine internal issues & external issues by processes/ organization context (45 minutes). Workshop 2: Root cause determination based on Fish Bone method (45 minutes). Presentation and practical comments for learning (1 hour).
Day2	9am~1pm	Workshop 3: Conduct risk management using FMEA work sheet (3 hours). Presentation and practical comments for learning (1 hour).
	1pm~2pm	Lunch Break
	2pm~5pm	Workshop 4: Performing residue risks assessment/ evaluate effectiveness of implemented controls (2 hours). Presentation and practical comments for learning (1 hour). End of the training and workshop

Revision No.: 1 SM Effective Date: 1/8/2025