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 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”