Days: 2 

 7:30 AM- 4:30 PM MST

Corrective Action Training – Root Cause & CAPA 

In this course, you’ll learn how to use a simple 8-step approach to correcting and preventing problems or nonconformities that exist anywhere in your 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.

This corrective action training is a great course for anyone learning to deal with corrective actions for the first time or anyone who needs a refresher to calibrate your knowledge and build 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 and 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

Days: 2 

 7:30 AM- 4:30 PM MST

Learn Pharma & Medical Device CAPA

Come learn the FDA 21 CFR and ISO 13485 requirements for a regulatory-compliant CAPA system and records. You will leave this training knowing how to perform effective root cause investigations that address, resolve, and prevent the issue(s) from recurring. This same CAPA methodology can be used to address Regulatory audit findings throughout the world.

This course teaches:

✔ The regulatory requirements for pharmaceutical and medical device CAPA:

• 21 CFR Part 4 – Good Manufacturing Practices for Combination Products
• 21 CFR Part 820 – Quality System Regulations for Medical Devices; Good Manufacturing Practices for Devices
• 21 CFR Part 801 – Labeling of Medical Devices
• 21 CFR Part 201 – Labeling of Drugs
• 21 CFR Part 210 and 211 – Good Manufacturing Practices in Manufacturing, Processing, Packing or Holding Drugs
• ISO 13485:2016 – Quality System Requirements for Medical Devices (and comparison to MDSAP and EU MDR/IVDR requirements)
• EU MDR CAPA Requirements related to: Article 83 PMS, Article 10 Manufacturing, Article 89 Serious Incidents

✔ How to perform effective fast-paced root cause analysis and complaint investigations– no more “best-guesses”

✔ 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

Learning Objectives:

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

Who Should Attend

• Do you do Corrective Actions? – THEN YOU SHOULD ATTEND!
• Quality Engineers (QE)
• Manufacturing Engineering (ME)
• Process Engineers & Technicians
• Electrical Engineers (EE) and Technicians
• Top Management – Why? They are ultimately responsible for ensuring the CAPA system is working effectively.
• Operations Directors & Management
• Engineering Directors & Management
• Marketing Directors & Management
• Manufacturing Directors & Management
• Regulatory Directors & Management
• Quality Assurance Directors & Management
• Purchasing Managers
• Supply Chain Managers who deal with SCAR and CAR processes.
• ANYONE WHO THINKS THEY KNOW MEDICAL DEVICE CAPA but really doesn’t get it, making them a prime target for a HUGE FDA finding that will ROCK their world and WASTE ALL SORTS of time and resources.

Class Agenda

Day 1

• Overview – Why CAPAs are required
  • Overview of the Regulatory requirements for CAPA in the following countries:
  • USA (FDA)
  • Australia (TGA)
  • Brazil (ANVISA)
  • Canada (CMDR)
  • Japan (PMDA)
  • European Union (including BREXIT)
• Typical Problems with Root Cause Investigations
  • 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
  • Top Management, Operation Management, Marketing Management, Engineering, Quality, Design, Frontline Management, Supervisors, Worker
• Step 1: Assigning a corrective action team leader: cross functional team
• Step 2: Describing the problem – COPQ
  • Activity – Risk Ranking for Quality Events – Deciding: Proportionate to the Effects
  • Activity – Medical Device CAPA Case Study #1: What constitutes an effective CAPA?
  • Activity – Detailed problem descriptions
• Step 3: Containing the problem
  • Case Study – CAPA Case Study #2: What is proper Containment of the problem?
• Step 4: Identifying the root cause or causes
  • System, process, & product causes
  • Root cause/data investigation tools (flow charts, histograms, Pareto charts, Paynter charts, control charts, run charts, etc.)
• Data Collection and Analysis
  • Check sheets, graphs, and tables for discrete data collection
  • Surveys, interviews, and field observation for opinions or less precise data
  • Activity – “5 Whys” method, 3×5 Whys, 5-Whys Tree
  • Activity – Ishikawa or Cause & Effect Diagram

Day 2

• Step 5: Verifying the root cause or causes
  • Activity: Likely Cause Worksheet: CAPA Case Study #2
  • Activity: 5-W 2-H Proof: CAPA Case Study #2
  • Pareto or 80/20 Rule, I can’t work EVERY cause, which ones?
• Step 6: Implementing corrective actions
  • Band-Aids vs Long-Term improvement: ST, IT and LT Corrective Actions
  • Corrective Action Plans: managing resources and achieving permanent improvement
• Step 6a: Risk Assessment: verify CAPA does not impact regulatory or safety requirements
  • Risk Management Process: ISO 14971 MD application of Risk Management
  • Hazards, Hazardous Situations and Harms – keeping your device Safe and Effective
  • Determining Probability of a Hazardous Situation presenting itself (P1), and of a Harm resulting (P2)
  • Activity: FMEA for CAPA Case Study #2
• Step 7: Verifying corrective action effectiveness
  • Production Process Audits: are proactive controls In-Place
  • Layered Process Auditing: Effecting permanent Change in your Organization
  • Crafting Effectiveness Check plans for each Corrective Action
  • Activity: Effectiveness Plan: CAPA Case Study #2
  • Paynter Charting: temporary Effectiveness Check
• Step 8: Closing the Corrective Action – Finally ALL DONE
  • Considering Preventive Actions:
    • Preventive vs. Corrective Actions: FDA and Final Rule FDA 820 Considerations
    • FMEAs – it’s all Preventive or Proactive
    • 3×5 Whys and “Read Across”
  • Congratulate the TEAM!
• Course Insights and Final Exam

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?

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 Training: Problem-Solving Requirements for Suppliers

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

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

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