Date / Registration

AS13000 Training (8-D): Root Cause & Corrective Action for Aerospace

Days: 2

Time: 7:30 a.m.- 4:30 p.m. MST

Overview

As Root Cause CAPA for Aerospace, an AS13000 training is a must-have. If you are a Boeing, Airbus, or other top OEM supplier, you need this class! All suppliers for the top OEM’s are required to have an 8D Practitioner. This course fulfills the training and testing requirements to become an 8D Practitioner.

AS13000 defines the Problem-Solving standard for suppliers within the aero-engine sector, with the Eight Disciplines (8D) problem-solving method being the basis for this standard.

This 2-day course provides students with a comprehensive and standardized set of tools to become an 8D practitioner and meets all the requirements of “training syllabus” (see AS1300 APPENDIX C). Successful application of 8D achieves robust corrective and preventive actions to reduce the risk of repeat occurrences and minimize the cost of poor quality. This is essential to enable long-term customer-supplier relationships and positively contributes towards zero defects and customer satisfaction.

This course includes the practical application of each of the 8D disciplines.

Learning Objectives:

Lead and Facilitate an 8D Problem Solving Activity to AS13000 Requirements
Complete an AS13000 8D Problem Solving Template
Apply a Problem-Solving Toolkit
Recognize and deal with issues of Team Dynamics and Challenging People
Practice Effective Customer / Stakeholder Management
Reduce Risk of Problem Recurrence

Who Should Attend:

An AS13000 training is a requirement for Aerospace Suppliers of any top OEM. 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-D process.

Agenda

Day 1

Introduction & 8-D Practitioner Requirements
Problem Solving Terminology and Definitions
Activity #1 Standard Terminology
Review of Standard
Requirements for an 8-D Practitioner Appendix C
Topics: Problem Solving Form Append. A, Team Dynamics, Questioning and Listening Techniques, Basic Tools overview
Methods: Appendix B: Questions, Brainstorming, Comparison Sheets, Check Sheets/Talley Sheets, Histograms, Scatter Diagrams, Run and Control Charts, Pareto Analysis, Human Factors, Analysis Techniques, Root Cause Chain

Case Studies:

Activity #1.1 Inputs for Process Flow Diagram
Activity #1.2 Is/Is Not and 8D Form
Case Studies Cont. :
Activity #2.1 5W2H Define the Problem
Activity #2.2 Define the Problem 8-D form
Activity #2.3 PCB CAR Review/8-D D2 & D3
Activity #3.1 Ishikawa – Fishbone

Day 2

Case Studies Cont. :
Activity #2.1 5W2H Define the Problem
Activity #2.2 Define the Problem 8-D form
Activity #2.3 PCB CAR Review/8-D D2 & D3
Activity #3.1 Ishikawa – Fishbone

Date / Registration

CAPA & Root Cause Investigation for Medical Device & Pharmaceuticals Training

Days: 2 • CEU Hours: 1.6

7:30 AM – 4:30 PM MST

Learn Root Cause Investigation & CAPA in Medical Devices & Pharmaceuticals.

Overview

Corrective and preventive action (CAPA) failures are among the most common—and most costly—issues cited by the FDA. For medical device and pharmaceutical companies, an ineffective CAPA system can trigger major compliance problems, regulatory scrutiny, and product risks. But when done right, CAPA in medical devices becomes a powerful driver of quality improvement and risk reduction.

This practical, two-day live-online training equips you with the skills and tools to build and maintain a compliant, effective CAPA system in line with FDA 21 CFR and ISO 13485 requirements. Designed specifically for professionals in medical device and pharmaceutical industries, the course teaches you how to perform efficient root cause investigations and develop corrective actions that truly solve problems and prevent recurrence.

Led by experts in medical device and pharma compliance, this course covers:

Key CAPA requirements from 21 CFR Parts 4, 820, 210/211, 201/801, and ISO 13485.
EU MDR expectations, including Article 83 (PMS), Article 89 (Serious Incidents), and Article 10 (Manufacturing).
Fast-paced, fact-based investigation tools including 5 Whys, Fault Tree Analysis, and Fishbone Diagrams.
Real-world case studies that walk through containment, root cause analysis, corrective action planning, and verification of effectiveness.
Practical tips for documenting CAPA activities to meet global regulatory expectations.
Risk management tools like FMEA and incident risk analysis to enhance the impact of your CAPA system.

Whether you’re responding to complaints, audit findings, or internal quality events, you’ll leave this course with the confidence to manage CAPA in medical devices and pharmaceuticals with clarity, consistency, and compliance.

Topics

The regulatory requirements for CAPA in medical devices and pharmaceuticals.
How to perform effective fast-paced root cause analysis and complaint investigations.
How to document complaint investigations and maintain records to demonstrate compliance.
Root cause investigation methods, such as:
- The 5 Whys: Including 5-Whys Tree and 3×5 Whys (or 3-legged 5-Whys)
- Fault Tree Analysis
- Cause and Effect
- Flow Charting
- Pareto Charting
- Fish-bone/6 M approach (Man, Method, Machine, Material, Milieu (Measurement & Mother Earth)
Other helpful pharma & medical device CAPA Tools including:
- 5-W 2-H and 5-W 2-H Proof
- FMEA
- Containment approaches
- Incident Risk Analysis
- Paynter Charts
- Layered Process Auditing
- Corrective Action Plans
- COPQ approach to CAPA profit enhancement

CAPA in Medical Device - Woman opening a machine with vials

Who Should Attend

Quality Engineers (QE)
Manufacturing Engineering (ME)
Process Engineers & Technicians
Electrical Engineers (EE) and Technicians
Top Management – They are ultimately responsible for ensuring the CAPA system is working effectively.
Operations Directors & Management
Engineering Directors & Management
Manufacturing Directors & Management
Regulatory Directors & Management
Quality Assurance Directors & Management
Purchasing Managers
Supply Chain Managers who deal with SCAR and CAR processes

Training Objectives For CAPA in Medical Devices

Practice within a compliant corrective action & preventive action (CAPA) process.
Perform effective root cause investigations.
Understand when and how to apply the appropriate root cause investigation tool/method.
Understand which records are required to demonstrate compliance to the FDA’s CFR Part 4 and CFR Part 820 regulations and ISO 13485 requirements.
Establish effective corrective action plans.
Plan & perform a Verification of Effectiveness (VoE) to assess if the corrective actions resolved the root of the problem.
Understand how to keep the CAPA process SIMPLE, effective, and adding value while reducing costs.
Understand how CAPA and Kaizen Events (Proactive) work together to demonstrate compliance.
Understand the interrelationships between: Nonconformities, Complaints, Post Market Surveillance and QMS monitoring and statistical techniques.

Agenda

Day 1

Part 1: Overview – Why CAPA in Medical Devices are Required

Part 2: Typical Problems with Root Cause Investigations

Part 3: Responsibilities for Root Cause and Corrective/Preventive Action

Part 4: Step 1: Assigning a Corrective Action Team Leader: Cross-Functional Team

Part 5: Step 2: Describing the Problem – COPQ

Part 6: Step 3: Containing the Problem

Part 7: Step 4: Identifying the Root Cause or Causes

Part 8: Data Collection and Analysis

Day 2

Part 1: Step 5: Verifying the Root Cause or Causes

Part 2: Step 6: Implementing Corrective Actions

Part 3: Step 6a: Risk Assessment: Verify CAPA Does Not Impact Regulatory or Safety Requirements

Part 4: Step 7: Verifying Corrective Action Effectiveness

Part 5: Step 8: Closing the Corrective Action

Part 6: Course Insights and Final Exam

Related Courses


ISO 13485 Lead Auditor Training – Recognized by Exemplar Global	cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training	MDSAP Training – Recognized by Exemplar Global	ISO 14971 Training – Recognized by Exemplar Global

Date / Registration

Root Cause Analysis, Corrective Action and Preventive Action CAPA Training

Days: 2

7:30 AM- 4:30 PM MST

Overview

Mistakes happen and processes fail, but unresolved issues and recurring problems can lead to wasted resources, compliance risks, and operational inefficiencies. It’s important for organizations to have effective root cause analysis procedures in order to ensure that these issues are corrected and prevented in the future.

To help organizations tackle these challenges, Axeon’s Root Cause Analysis & CAPA training provides a structured, 8-step approach to Root Cause Analysis (RCA), Corrective Action, and Preventive Action (CAPA). This course applies to any industry or organization looking to improve problem-solving effectiveness. It emphasizes proven methodologies for identifying root causes, implementing corrective actions, and preventing recurrence, all while ensuring compliance with quality management system requirements.

Using industry-recognized tools such as Five Whys, Ishikawa diagrams, and Failure Modes and Effects Analysis (FMEA), this Root Cause Analysis & CAPA training course provides a practical framework for improving process reliability and sustaining long-term improvements.

Available both online and in-person, this interactive course combines expert instruction with hands-on exercises and real-world case studies. Whether you’re new to corrective actions or looking to refine your approach, this training will equip you with the skills needed to drive meaningful improvements in your organization.

Root Cause Analysis & CAPA Training Key Topics

Root Cause Analysis fundamentals and common challenges
Systematic problem description and containment strategies
Data-driven tools for identifying and verifying root causes
Developing and implementing effective corrective actions
Layered Process Audits and verification methods
Preventing recurrence and closing corrective action reports

CAPA Training - Two men working on a white board

Who Should Attend

Employees responsible for conducting or managing corrective actions
Quality managers, engineers, and auditors involved in CAPA processes
Supervisors and frontline managers overseeing process improvements
Production and operations personnel responsible for identifying and resolving issues
Regulatory and compliance professionals ensuring adherence to quality standards
Team members involved in problem-solving initiatives or process improvement projects
Anyone seeking a structured approach to root cause analysis and corrective action

Root Cause Analysis & CAPA Training Objectives

Understand the ISO requirements for Corrective Action, Risk-Based Thinking, and/or Preventive Action.
Experience a variety of tools and methods for performing Root Cause Analysis (RCA).
Learn a variety of methods and tools for performing effective Corrective Actions.
Understand when a full RCA is necessary or when an Apparent Cause Analysis or Correction Only is preferred.

Agenda

Day 1

Part 1: Introductions

Part 2: Terminology & Definitions

Part 3: ISO Standard Requirements

Part 4: Incident Investigation & Risk Assessment

Part 5: 8D Corrective Action Methodology & Case Study

Part 6: 8D Root Cause & Corrective Action (Part 1)

Day 2

Part 6: 8D Root Cause & Corrective Action (Part 1 Continued)

Part 7: Human Factors

Part 8: 8D Root Cause & Corrective Action (Part 2)

Part 9: Real-World Case Study

Part 10: Final Exam

Related Courses


CAPA & Root Cause Investigation for Medical Device & Pharmaceuticals Training	AS13000 Training (8-D): Problem Solving Requirements for Suppliers Training	ISO 9001 Lead Auditor Training	Human Factors Training

Date / Registration

Running Time 2 Hours

Includes Training Video and Slide Presentation

View the sample video below

Root Cause & CAPA

This course teaches the following tools: 5W2H, Brainstorming, Ishikawa/Fishbone, Cause & Effect Tree, Five Why’s and Pareto Charts.

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 a basic knowledge the the most common tools for Root Cause Analysis and Corrective & Preventive Action

Agenda

Root Cause & Corrective/Preventive Action Definitions

Depth of Root Cause Analysis

Eight Step Process

Root Cause, Corrective/Preventive Action Tools

5W2H

Brainstorming

Ishikawa or Fishbone Diagram

Cause & Effect Tree Analysis

Five Whys Method

Pareto Chart

Conclusion

Date / Registration

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 Human Factors online training 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 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 our Human Factors Online Training?

· 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

Date / Registration

Days: 1

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

Audience: Top management

Overview

A QMS (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

Root Cause, Corrective & Preventive Action

Root Cause Analysis, Corrective & Preventive Action Training

What is CAPA?

Early Bird Pricing

AS13000A Training (8-D): Root Cause & Corrective Action for Aerospace -- $1295

AS13000 Training (8-D): Root Cause & Corrective Action for Aerospace

Overview

Learning Objectives:

Who Should Attend:

Agenda

Day 1

Case Studies:

Day 2