2-day ISO 14971:2019

Application of risk management to medical devices

3 Day Schedule: 7:30 AM – 4:30 PM MST   Audience: Beginner to Advanced

Overview

This class will teach participants to turn Risk Assessment into a well-organized systematic approach that targets and then reduces risk to the organization, customers and stakeholders. While Risk Management is a requirement for Medical Device Manufacturers, these same techniques can be used regardless of the products or services offered by your organization.

Who Should Attend?

• Anyone who needs to develop and implement a comprehensive Risk Management
• Program meets requirements for ISO 14971
• Any organization that needs a formal, disciplined approach to the identification, assessment and management of Risk
• Quality Managers
• Engineering Managers
• Internal and external auditors
• Design Teams
• Management Representatives
• Project Teams
• Anyone who needs to understand the difference between Risk Identification, Risk
• Assessment and Risk Management and how to put these important tools to work for your organization.

Course Objectives

• The components of risk management that can be applied to any organization, regardless of their products or customers
• How to design a risk management structure for your organization that gets results
• A means for demonstrating to customers and stakeholders the potential risks associated with products or processes and provide assurance that these have been effectively managed
• Tools used for Risk Assessment such as FMEA and FMECA
• How to quantify risk as the first step in establishing priorities for your organization

Agenda

Day 1 

• Risk terminology and theory from ISO 14971, ISO 13485
• History of risk management and relationship with Corrective and Preventive Actions
• Requirements of ISO 14971

• Design of framework for managing risk
• 4.3.2 Establishing risk management policy
• Integration into organizational processes
• Establishing internal communication and reporting mechanisms
• Establishing external communication and reporting mechanisms
• Implementing risk management
• Implementing the framework for managing risk & risk management process
• Continual improvement of the framework
• Communication and consultation
• Establishing the internal and external context
• Establishing the context of the risk management process
• Defining risk criteria
• Risk assessment

• Risk identification
• Risk analysis
• Risk evaluation
• Risk treatment

• Selection of risk treatment options
• Preparing and implementing risk treatment plans
• Monitoring and review
• Recording the risk management process
• Exercises B.1 – B.6 internal & external framework, risk treatment, risk monitoring, risk policy, risk analysis

Day 2

• Guidelines from ISO 14971
• Techniques – Risk Management
• Selection of risk assessment techniques

• Selection of techniques
• Availability of Resources
• The Nature and Degree of Uncertainty
• Complexity of risk
• Application of risk assessment during life cycle phases

• Types of risk assessment techniques

• Flow charts and process mapping
• Brainstorming
• Risk Checklists
• Delphi Method
• Process FMEA
• Design FMEA
• Fault Tree Analysis (Event Tree Analysis)
• HAZOP & HACCP
• Cause & Effect with 5-Whys & 7-M
• Preliminary hazard analysis
• Risk Ranking and Filtering

• Case Studies with application
• Organization’s Risk Procedures and Tools

• Case Studies from Organization’s Risk Analysis, Treatment and Monitoring

• Risk Applications in the Aerospace organization

• Internal Audit
• Training
• CAPA System
• Supplier Selection & Control
• Outsourcing – Special Processes
• Facilities and Equipment
• Design & Development
• Production and Process Controls
• Process Validation and Re-Validation
• Servicing

• Design FMEA Case Study
• Various Risk Case Studies
• Organization’s Case Studies
• Statistical Methods
• Test