quality risk management - pathwise · course participants will learn quality risk management...

Quality Risk Management

LEARNING OBJECTIVES Attendees of this course learn how to:

• Demonstrate what is important about

your business and safe for

customers.

• Identify the components of the quality

risk management process.

• Understand roles and responsibilities

in risk management.

• Discuss hazards and risks in designs,

systems, and processes.

• Assessment tools.

• Connect risk review to your

company’s quality system processes.

• Provide a documented, approved

rationale for your decisions.

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Risk Management is taught using a blended

approach of classroom

and real-life work

application. This

approach to learning

significantly increases

training and skill-set

retention, as well as allowing participants to

apply what they have

learned in a training

setting.

PathWise facilitators

have an extensive background in teaching

Risk Management

techniques in an FDA

regulated environment.  

Our Quality Risk Management course is designed to help effectively manage

risks as a formalized system. Course participants will learn Quality Risk

Management principles and applications; and become acquainted with the

necessary tools, techniques, tips and skills for effective implementation of

risk management.

COURSE MODULES 1) Quality Risk Management

Introduction

2) Risk Management Process and the

FMEA Tool

• FMEA is often the first step of a system reliability study. It involves reviewing as many components, assemblies, and subsystems as possible to identify failure modes, and their causes and effects. For each component, the failure modes and their resulting effects on the rest of the system are recorded in a specific FMEA worksheet.

AUDIENCE Risk Management is appropriate for

individuals who are regularly called

upon to mitigate risk to the quality

system. Examples include research

and design engineers, quality

assurance, and regulatory and

compliance personnel. We also have

a one-day course designed

specifically for risk management tools.

COURSE DURATION Two Days