Course contents:
- Introduction & Course Objectives
- Purpose of a CAPA system
- ISO standards and CAPA requirements
- Differences between corrections, corrective actions, preventive actions and ‘continuous improvement’
- How risk management is used in conjunction with the CAPA system
- Various investigation tools to identify root cause(s) and actions
- 8 D Methodology
- CAPA plans; how to write good CAPA plans, including resources and timing of actions; and how to effectively implement CAPA plans
- Effectiveness checks and various methods to achieve effectiveness checks
- External auditor perspective on CAPA systems and compliance expectations
- Q&A
- Conclude & Follow Up Process
Course Objectives:
On the course completion attendees will be able to:
- Describe the requirements for both Corrective and Preventive Actions as defined ISO 9001/ ISO 13485/TS 16949 Quality Standards.
- Define the key terms related to Corrective and Preventive Actions.
- Describe the difference between Corrective and Preventive Actions.
- Assess the effectiveness and efficiency of the Corrective and Preventive Action procedure.
- Produce both Corrective and Preventive Action Plans.
- Verify the effectiveness of a Corrective or Preventive Action taken.
