INTRODUCTION FOR CORRECTIVE ACTION AND PREVENTIVE ACTION
This practical, hands-on 2-days course teaches participants how to use structured and effective steps to correcting and preventing problems or nonconformities that exist anywhere in their organization. It can help your organization satisfy management system requirements for effective corrective action.
Corrective Action and Preventive Action are primary Quality Management System (QMS) processes that have challenged most organizations. Organizations often do not get the benefits or optimum performance out of the Corrective Action or Preventive Action process due to lack of understanding of the value, failure to invest the time required or because they are simply overwhelmed with the tasks. This course will cut through all of these roadblocks.
COURSE OBJECTIVES
- Method: To have an in-depth CAPA method. Provide a clear causal understanding of the event and can see the causal relationships. In a systematic, organized and clear in manner.
- Tools/process: Share technique/skill of asking questions and develop good sense of logical thinking process – questions to stimulate remembering not justification (5 Whys method, Logical Analysis tool etc.)
- Actions: Develop corrective action and preventive actions that provide the strongest safeguard to future error. (Example:-how to ensure corrective actions of human related issues,e.g “Education/Displine/Procedure” effectively implemented).
COURSE CONTENT
Introduction
- Who needs a CAPA process?
- What is a CAPA process?
- When should a company implement a CAPA process?
- Where within the organization does the CAPA process operate?
- Why must we invest time & effort to implement & manage a CAPA process?
Problem Identification process
- Reactive
- Proactive
- Prioritization
- Roles and responsibilities
- Problem definition
Problem solving techniques
- DMAIC approach
- 8D approach
Measuring the problem
- Process and definition
- Sampling and collection Plan
Determining the root cause
- Ishikawa diagram
- 5 Why’s
- Is/Is not analysis
- DOE
- How do you know that you have arrived at a root cause?
Choosing a corrective action
- Implementing and validating the corrective action
- Determining ownership
- Isolating & containing the problem
Preventive Action process
- Preventing Recurrence
- Is Zero defect possible?
- How to go towards Zero Defect?
Identify solutions
- Brainstorming Techniques
- Evaluate solutions
- Why multiple solutions are important?
- Impact/effort analysis
Developing selected solutions
- Risk analysis
- Pilot testing
- Implementation planning
Human error reduction
- HER techniques
- Poka yoke
