Download to read offline
CAPA Training Material for corrective action and preventive action
- 1. CAPA Training CORRECTIVE ACTIONPREVENTIVE ACTION Prepared by: Izzati & Jasmin Date: 29/2/2024
- 2. Step 2 CAPA will(‘prevent’) the reoccurrence with the improvement that addresses the cause. Step 1 When something is wrong, CAPA is executed to fix (‘correct’) the issue. CAPA stands for Corrective Action and Preventive Action CAPA Meaning • CAPA is a problem-solving method with two step process. CAPA will identify, investigate, and address problems or non-conformities in products, processes and systems. The purpose of CAPA is to rectify existing issues and prevent their recurrence in the future.
- 3. When will beCAR / CAPA Issued? CAR/ CAPA Customer Complaint Management Review Output Internal Audit Product / Process related issues defect Supplier Quality Issue
- 4. Why implement CAPA? 1.Prevent problem from recurring 2. Reduce rework & scrap 4. Effectiveness of productivity 3. Reduce cost & money 5. Increase competitiveness 6. Increase customer satisfaction
- 5. CAPA Process FlowChart 2. Verified & Agreed. 4. Containment Action 5. Root Cause Analysis 6. Demonstrate the root cause 7. Propose corrective action 8. Propose preventive action 9. Verification by the issuer 1. Reject/NC Found Root cause accept? Yes No 3. CAR Issuance (>20% rejection) Time frame to close CAPA/CAR: 9 days (Urgent Case) 21 days (Normal Case) 24 hours
- 6. Specify the problemby identifying in quantifiable terms the WHO, WHAT, WHEN, WHERE, WHY, HOW, HOW MANY (5W 2H) for the problem. Problem Statement Where does it happen? When does it happen? What is the problem? Who is affected by the problem? Who is involved in the problem? How much could be affected by this problem? On 21st February 2024, operator found 5 puddles of water on the production floor. The puddle has caused the operator a difficulty to do their job. When Who What Where
- 7. Containment actionis to limit a problem extent while continue normal operation until the root cause is defined and permanent corrective action is implemented. The containment area should cover production, finished goods, customer on hand, Incoming material and warehouse storage. Containment Action 100% sorting of components Stop shipment Quarantine the defect item from good item Stop machine Issue quality alert to related person
- 8. Useful Tool ToDetermine Root Cause Fishbone Diagram (5 M 1 E) The “5 Whys”
- 9.
- 10. High Coolant Consumption Lack oftraining Poor shift communication Machine break down Blocked hoses Adjusting concentration setting Biocide level Delayed measurement
- 11.
- 12. Problem Statement On 21st February2024, operator found 5 puddles of water on the production floor. The puddle has caused the operator a difficulty to do their job. Containment Action *Immediate action 1. Close the pipe. 2. Seal the pipe if the leakage is not severe.
- 13. Puddle of wateron the floor Leak in overhead pipe Water pressure is set too high Water pressure valve is faulty Valve is not in preventive maintenance program 5 Why Analysis WHY 1 WHY 2 WHY 3 WHY 4 WHY 5 Based on the example problem statement, here is the 5 Why example:
- 14. Preventive Action Corrective Action CA: Waterpressure valves placed in preventive maintenance program PA: Develop checklist form to ensure equipment is reviewed in preventive maintenance program. • Carried out after a nonconformity has already occurred • To deal with the mistake/problem that already happen • Temporary action • To act on a potential mistake and to prevent it happens again on similar process or other area • Permanent action VS
- 15.
- 16. Non Conformity Issue: On21st February, Customer found 3 pcs of Part A Mix with Part B at their Warehouse. Please list out the root cause using any quality tool.
- 18.
- 19.
Editor's Notes
- #1 j
- #2 CAPA stands for Corrective Action and Preventive Action CAPA is a problem-solving method with two-step process. Step 1: When something is wrong, CAPA is executed to fix (‘correct’) the issue. Step 2: CAPA will identify, investigate, and address problems or non-conformities in products, processes and systems.