Risk Management

Risk Management is a fundamental skill required in nearly every industry. Whether your company drills for oil, manufactures cars, manages investments, or delivers packages, you face a wide variety of risks every day that range in severity from minor inconveniences potentially career / company ending disasters. To make matters worse, most people instinctively do a poor job of recognizing and assessing risks due to variety of cognitive biases that are a part of human nature.

This course teaches the basics of Risk Management which includes Risk Identification, Risk Assessment, and Risk Disposition. Participants in this course will learn why most untrained do a poor job of managing risks and how to use tools such as Failure Mode and Effects Analysis (FMEA), Fault trees, and Fishbone Diagrams to better manage risks.

FMEAs are required in many industries including Medical Devices (21 CFR 820, ISO 14969, ISO 14971) and Automotive (ISO/TS 16949:2009, APQP). The use of FMEAs is also strongly encouraged in Healthcare by the Joint Commission on Accreditation of Healthcare (JCAHO) and the Joint Commission Resources (JCR).

AGENDA

Why most people are so bad a managing risk

The wrong perceptions of risk lead to poor decision making

Definition of risk

The history and importance of FMEA

Identifying Risks

Assessing Risks

Failure Modes, Failure Effects, Severity, Likelihood, Detectability

Dealing with Risks

Risk avoidance, Risk transfer, Risk acceptance, Risk mitigation

A robust procedure for creating FMEAs

How to lead an FMEA team

Pre-work

Roles and Responsibilities

Running the meetings

Avoiding common problems

Case studies

Practice exercises

LEARNING OUTCOMES

1) Students will be able to identify and assess risks using an FMEA template

2) Students will be able to develop appropriate risk mitigation strategies

3) Students will be able to lead an FMEA team