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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.

We offer training for both medical and aerospace risk management.  ISO 14971 is the Medical Device Standard and ISO 31000 works with AS9100 and ISO 9001.

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 Root Cause Corrective Action and Preventive Action Course- $1295

2-Day Root Cause Analysis, Corrective Action and Preventive Action Training



Day 1: 7:30 am – 4:30 pm

Day 2: 7:30 am – 4:30 pm

Root Cause & CAPA 

This course teaches attendees how to use a simple 8-step approach to correcting and preventing problems or nonconformities that exist anywhere in their organization. It can help to satisfy quality management system requirements for planning and establishing a process for corrective action.

Learning Objectives

Learn the process for completing a formal corrective action request. You’ll learn how to describe a problem, conduct causal analysis and what information is needed in order to ensure a corrective action is complete and effective.

A great course for anyone learning to deal with corrective actions for the first time or if you just need a refresher to calibrate your knowledge and build more confidence in your abilities.

Who Should Attend

Any employees that will conduct a corrective action or participate as a team member, as well as any individual who would like to gain an in depth understanding of the 8-step approach for CAPA’s.




Day 1

  • Overview of Root Cause & Corrective/Preventive Action
  • 8-Step Closed-Loop Process
  • Typical Problems with Root Cause Analysis
  • Why most problem solving models don’t get to the root cause, and a solution
  • How analytical and creative thinking must be both separated and integrated
  • Difference between content and process thinking
  • Responsibilities for Root Cause and Corrective/ Preventive Action
  • Quality, Design, Frontline Management, Supervisors, Worker
  • Step 1: Assigning a corrective action team leader
  • Step 2: Describing the problem
  • Activity #1 – Detailed problem descriptions
  • Step 3: Containing the problem
  • Activity #2 – Containment Potential
  • Step 4: Identifying the root cause or causes
  • System, process, & product causes
  • Root cause/data analysis tools (flow charts, histograms, Pareto charts, Paynter charts, control charts, run charts, etc.)
  • Data Collection
  • Population versus sampling; options for sampling
  • Check sheets, graphs, and tables for discrete data collection
  • Surveys, interviews, and field observation for opinions or less precise data
  • Activity #3 – “5 why” method
  • Activity #4 – Ishikawa or Cause & Effect Diagram
  • Activity #5 – FMEA (Failure Modes Effect Analysis)
  • Step 5: Verifying the root cause or causes
  • Step 6: Implementing corrective actions
  • Step 7: Verifying corrective action effectiveness
  • Step 8: Closing the corrective action report
  • Preventing recurrence
  • Acknowledging the improvement


Day 2

Application of Closed-Loop Root Cause & Corrective/Preventive Action Tools

  • Step 1: Assigning a corrective action team leader
  • Step 2: Describing the problem
  • Step 3: Containing the problem
  • Step 4: Identifying the root cause or causes
  • Step 5: Verifying the root cause or causes
  • Step 6: Implementing corrective actions
  • Step 7: Verifying corrective action effectiveness
  • Step 8: Closing the corrective action report


Review & Exam


2-Day Human Factors - $1295

Human Factors – $1295

Days: 2 • 

 Day 1-2: 7:30 a.m.–4:30 p.m.


Course Description

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.


Course Objectives

  • 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.



Course Syllabus


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


Final Test



2- Day Risk Management: AS13004 PFMEA Training - $1295

2- Day Risk Management

AS13004 PFMEA Training

This is Risk Management for the Aerospace and ISO 9001.

This class teaches participants a well-organized, systematic approach to Risk Assessment that targets and reduces risk to the organization, customers and stakeholders. While Risk Management is a requirement for Aerospace and ISO 9001 Manufacturers, these same techniques can be used regardless of the products or services offered by your organization.

Who should attend

  • Any organization that needs a formal, disciplined approach to the identification, assessment, and management of Risk.
  • Addresses requirements for ISO 9001 Risk-based Thinking, AS9100 Operational Risk Management, and
    AS13004 PFMEA and Control Plans.
  • Quality Managers
  • Management Representatives
  • Engineering Managers
  • Internal and external auditors
  • Design Teams
  • Project Teams

What you will learn

  • How to address Risk-Based Thinking requirements of ISO 9001:2015 and AS9100 (per ISO 31000).
  • How to address the Operational Risk Management requirements of AS9100 (per AS13004).
  • Tools used for Risk Assessment such as FMEA and PFMEA.
  • How risk management can be applied to any organization, regardless of its products or customers.
  • 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.
  • How to quantify risk as to the first step in establishing priorities for your organization.

Day 1 Agenda

  • Risk terminology
  • The four-step Risk Management process
  • Risk-based Thinking requirements of ISO 9001:2015 & AS9100D
  • Strategic vs. process risk management
  • Tools, methods and a streamlined approach for addressing risk-based thinking requirements.
  • Hands-on exercises

Day 2 Agenda

  • Guidelines for performing Failure Modes and Effects (FMEA) analysis
  • Detailed hands-on case study developing an FMEA analysis, with tools for completing each stage.
  • Requirements for Operational Risk Management.
  • Overview of AS13004 – Process Failure Modes and Effects Analysis and Control Plans.
  • Guidance on using AS13004 methodology to meet Operational Risk Management requirements.

1-Day Maximizing the ROI from your Quality Management System- $950

Maximizing the ROI from your Quality Management System

1-day Managment Training

Days: 1

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


Learning Outcomes

  • 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.

Couse Syllabus

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

Final Test