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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- 90 Days in Advance
• $100 off- 60 Days in Advance
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
- 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
- CAPA System
- Supplier Selection & Control
- Outsourcing – Special Processes
- Facilities and Equipment
- Design & Development
- Production and Process Controls
- Process Validation and Re-Validation
- Design FMEA Case Study
- Various Risk Case Studies
- Organization’s Case Studies
- Statistical Methods
Human Factors – $1295
Days: 2 •
Day 1-2: 7:30 a.m.–4:30 p.m.
Human Factors is a term that appears in the latest versions of several ISO standards, including:
- ISO 9001:2015 General manufacturing QMS
- AS9100D:2016 Aerospace QMS
- ISO 14971:2007 Risk management for medical devices
- ISO 45001:2018 Occupational health and safety
This course helps you to understand human factors in the context of each standard. You will learn how to apply the concept of human factors to your management system and address the standard requirements. You will also receive practical tools, proven methodologies, and helpful tips to make the job easier for you.
As will all of Axeon’s courses, this is a practical, how-to course that is not bogged down in academic discussions. We use case studies, practice exercises, and learning activities to keep the training activities and build competence.
Who Should Attend?
Quality Managers, Managment Representatives, Quality Engineers, Safety Managers, and Top Management
ALSO: Quality Consultants, Those involved in performing corrective actions, Those involved in medical device risk management, and Regulatory Affairs Specialists
None. Our students range from seasoned quality professional to novices. Our goal is to meet everyone at their current level of competence and increase it.
- Understand the requirements of human factors in the context of each standard.
- Learn how to address human factors within your organization’s quality and/or safety management system.
- Provide practical tools and methods for addressing human factors.
Intro to Human Factors
Review ISO Standard Requirements: 9001, AS9100D, 14971, 45001
Definitions of Human Factors by Standard
Human Factors and Root Cause Analysis
Corrective Action and Human Factors
The 13 Most Common Human Factors
Activity: Applying Human Factors in Corrective Action
Human Factors and Poka-Yoke
Definition & History of Poka-Yoke
Methodology for Poka-Yoke
Activity: Applying Poka-Yoke to Human Factors
Human Factors and Health & Safety
Definition of Human Factors in Health & Safety
Human Factors and Ergonomics
How Human Factors influence Safety at Work
Activity: Applying Human Factors to Safety
Human Factors and Medical Devices
Methodology for Considering Human Factors in Risk Assessment
Device Design According to Human Factors Consideration
Human Factors in Post-Market Surveillance
Maximizing the ROI from your Quality Management System
1-day Managment Training
Schedule: 7:30-4:30 daily
Audience: Top management
A Quality Management System is NOT a cost of doing business. It’s an investment. And top management should expect to get a financial return on that investment. However, the Return On Investment (ROI) they receive will be greatly impacted by the level of leadership and commitment they provide concerning the management system.
The newest versions of most ISO management standards have amplified the requirements for top management, in accordance with ISO 9001:2015. In this highly interactive course, senior managers will learn how to fulfill their new responsibilities, take accountability, and maximize the ROI they get from their management systems.
Who Should Attend
- Top management from organizations with quality, environmental, or safety management systems, including chief executives, general managers, and other senior managers.
- Quality Managers and/or Management Representatives are NOT the intended audience for this course, although they are certainly welcome.
To provide decision-makers with information that will help them to provide direction for their existing or planned quality management system
- Understand the new top management ISO requirements and how to accomplish them.
- Understand the responsibilities that can be delegated to a management representative, and those responsibilities top management must retain.
- Learn how to maximize the ROI from your management system.
- Receive practical methods, tools, and tips for using your QMS to enhance organizational performance.
- Learn the mistakes to avoid that can negatively impact your management system.
Benefits of a Quality Management System
Overview of Potential Benefits, including Return on Investment (ROI)
Why Top Management Leadership and Commitment is Important.
Creating an Organizational Culture that Supports Quality.
Overview of Quality Principles
What is Quality? What is Quality Management?
Top Management Responsibilities (per ISO 9001) and How to Accomplish Them.
How to Maximize the ROI from your QMS
ROI Depends on an Organization’s Level of Commitment to its QMS System.
Using your QMS processes to ensure Customer Satisfaction and Increase Profitability.
Using the Process Approach to Manage Quality (Turtle Diagram).
Establishing KPIs and Determining Process Effectiveness.
Continuously Improving your QMS.
Reducing the Costs of Poor Quality (COPQ).
Using Your QMS to Manage Risks and Support Your Strategic Direction.
The Five Biggest Mistakes Executives Make with Quality Management