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

  1. Understand the ISO requirements for Corrective Action, Risk-Based Thinking, and/or Preventive Action.
  2. Experience a variety of tools and methods for performing Root Cause Analysis (RCA).
  3. Learn a variety of methods and tools for performing effective Corrective Actions.
  4. 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