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

ISO 14971 Training 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 learned in this ISO 14971 training 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 14971:2019 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.

Agenda

Day 1 

• Risk terminology and theory from ISO 14971 and 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