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Risk Management

Why is Risk Management Important?

Risks affecting organizations can have consequences in terms of economic performance and professional reputation, as well as environmental, safety and societal outcomes. Therefore, managing risk effectively helps organizations to perform well in an environment full of uncertainty.

ISO 31000:2009, Risk management – Principles and guidelines, provides principles, framework and a process for managing risk. It can be used by any organization regardless of its size, activity or sector. Using ISO 31000 can help organizations increase the likelihood of achieving objectives, improve the identification of opportunities and threats and effectively allocate and use resources for risk treatment.

Early Bird Pricing

 

• $200 off- 60 Days in Advance

 

• $100 off- 30 Days in Advance

2-Day Risk Based Thinking and Risk Management ISO 31000 & 14971 Training - $1295

2-Day Risk Based Thinking and Risk Management

ISO 31000 & 14971

Risk Management for ISO 9001:2015, AS9100:2016 and ISO 13485:2016

 Quality Risk Management Principles and Practices

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 Aerospace and 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 and ISO 31000
  • 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.

 

What you will learn

  • 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

 

Day 1 Agenda

  • Risk terminology and theory from ISO 14971,ISO 13485, and ISO 31000
  • 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
  • Additional Requirements for ISO 31000

 

Day 2 Agenda

  • Guidelines from ISO 14971/31000 Risk Assessment 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