courses

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

Root Cause Analysis, Corrective Action and Preventive Action Training

Days: 2 

 7:30 AM- 4:30 PM MST

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.

 

Agenda

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
    • What, Who, When Plans
    • Short Term, Medium Term, Long Term Actions
  • Step 7: Verifying corrective action effectiveness
    • Layered Process Auditing
    • Charting: Paynter Charts
    • Quality  Assurance SPC
  • Step 8: Closing the corrective action report
  • Preventing recurrence
  • Acknowledging the improvement

 

Day 2

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

  • “Live” Case Studies and Application
  • 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
  • New requirements for Corrective Action “documented information”

Review & Exam

 

Aerospace Risk Requirements and AS13004 PFMEA & Control Plans

Risk Management for ISO 31000:2018

Days: 2 

 7:30 AM- 4:30 PM MST

 

Overview

This class teaches participants the Aerospace Risk Requirements (per AS9100, 9110, and 9120) as well as the specific requirements for Operation Risk as defined in AS13004 PFMEA and Control Plans.  The course follows a well-organized, systematic approach to Identify, Assess, and Mitigate Risks that impact Aerospace organizations and the risks to their customers and stakeholders. While Risk Management is a basic requirement of ISO 9001, the Aerospace standards incorporate all of these requirements and add further requirements to make aerospace products and services safe and effective throughout the Supply Chain.  Further, with reduced risks inherent in the Design and Manufacture of aerospace articles, the Costs associated with their manufacture should be reduced.

Who Should Attend

  • Any organization that needs a formal, disciplined approach to the identification, assessment, and management of Risk.
  • Organizations that must meet the requirements–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 DFMEA, Process Flow Diagrams, PFMEAs and Control Plans.
  • 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 the first step in establishing priorities for your organization.
  • Methods for controlling risks within your Supply Chain

 

AGENDA

Day 1

  • Risk terminology
  • Four-step Risk Management process outlined in ISO 31000
  • Risk-based Thinking requirements of ISO 9001:2015 and AS9100D
  • Strategic vs. process risk management
  • Tools, methods, and a streamlined approach for addressing risk-based thinking requirements.
  • Hands-on exercises

Day 2

  • Aerospace risk terminology
  • Overview of APQP and PPAP risk tools: Process Flow Diagrams, PFMEAs and Control Plans
  • How to develop a Process Flow Diagram (identifying process risks)
  • Guidelines for performing a Process Failure Modes and Effects (FMEA) analysis
  • Creating an effective Control Plan used to manufacture and control and resolve ongoing process risks
  • 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

Human Factors

And How to Address Them

Days: 2

Time: 7:30 AM- 4:30 PM MST

Audience: Beginner to Advanced

Overview

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 with 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 Also:
·     Management representatives ·     Quality consultants
·     Quality engineers ·     Those involved in performing corrective actions
·     Safety managers ·     Those involved in medical device risk management
·     Top management ·     Preparation Of Checklists From Process Analysis
·     Regulatory affairs specialists

 

Prerequisites

 

None.  Our students range from seasoned quality professionals 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.

 

Agenda

 

Day 1 

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

Day 2

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

Maximizing the ROI from your Quality Management System

Days: 1

Time: 7:30 AM-4:30 PM MST

Audience: Top management

Overview 

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.

Why Attend?

This class will help to show the true value of your quality management system and how much it really adds to your bottom line. It will also help your company to increase the ROI of your QMS.

If you want to improve your company’s bottom line or show your boss how much your QMS is already contributing to profits then this class is for you.

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
  •  Anyone considering implementing an ISO quality system

Course Objectives

  • 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.
  • To provide decision-makers with information that will help them to provide direction for their existing or planned quality management system

 

Agenda

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