courses

Root Cause Analysis, Corrective & Preventive Action Training

What is CAPA?

Corrective action and preventive action are improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations.[1] CAPA is a concept within good manufacturing practice (GMP). It focuses on the systematic investigation of the root causes of non-conformities in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).

Why use Corrective & Preventive Action?

Corrective actions are implemented in response to customer complaints, undesired levels of internal nonconformity, nonconformities identified during an internal audit or adverse or unstable trends in product and process monitoring such as would be identified by SPC. Preventive actions are implemented in response to the identification of potential sources of non-conformity.

Keys to making CAPA work

To ensure that corrective and preventive actions are effective, the systematic investigation of the root causes of failure is pivotal. CAPA is part of the overall quality management system (QMS).

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

 

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

AS13000 8-D Root Cause Corrective Action

Problem-Solving Requirements for Suppliers Training

Days: 2

Time:  7:30 a.m.- 4:30 p.m. MST

Overview

This class is Root Cause CAPA for Aerospace. If you are a Boeing, Airbus, or other top OEM suppliers you need this class! All suppliers for the top OEM’s are required to have an 8D Practitioner. This training 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:

This 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

2- Hour Introduction to Root Cause Corrective/Preventive Action Tools- Training Video

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

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