Corrective and Preventive Action (CAPA) in MedTech

8D problem solving involves the following 8 steps:

  1. Establish a team
  2. Elaborate the problem and expand on its scope
  3. Immediate containment plan
  4. Permanent containment plan using root cause analysis
  5. Verify the permanent corrective action
  6. Validate the permanent corrective action
  7. Prevent the recurrence of the problem
  8. Recognize and reward the team’s efforts

8D problem solving is effective to prevent recurrence of the defects and aims at achieving zero defect in production process. It is used in cases such as quality returns or recalls. The problems can be tackled based on their severity levels.

SIPOC diagrams are the process control diagrams that help us to identify the stages of the production pipeline where a non-compliance or defect occurs.

Tools for Finding the Root Cause

  1. Fishbone diagram
  2. Preliminary Hazard Analysis (PHA)
  3. Fault Tree Analysis (FTA)
  4. Hazard and Operability Study (HAZOP)
Root cause analysis tool

Pareto charts are used when various causes of the problem have low severity. Cases of defects with high severity may not require the use of Pareto charts.


Leave a Reply

Your email address will not be published. Required fields are marked *