Root Cause Analysis, Corrective Action and Preventive Action Training

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 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.

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