quality risk management - pathwise · course participants will learn quality risk management...
TRANSCRIPT
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.
866.580.PATH www.pathwise.com
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