2-day ISO 14971:2019

Application of risk management to medical devices
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
Date/Registration