CAPA is a terminology used for reaching out to the Root cause of a problem and establishing the Corrective and preventive actions.
A systematic CAPA must have the following
Correct problem Statement
A correct problem statement is always helpful in concluding the root cause and thus establishing the CAPA. E.g. Customer statement might be shaft is not fitting in the bore but this is not the actual defect actual defect can be Shaft Diameter Too Big or Too Small. For problem resolution we must know what is the actual reason of shaft not getting fitted in the hole? And how much is the deviation from the specification.
Check the inventory available at various locations e.g. Customer end, In-transit, Finish Goods for dispatch, WIP, Stores and at Supplier end. Verify all the inventory for the said problem.
Always ask 5 W’s and 2 H’s before analyzing a problem.
- Who: – Who has reported the problem? It is important to know who is reporting the problem. Sometimes a production operator just raises an alarm without checking which part in assembly is actually having the problem.
- What: – what is the part no.
- When: – When is the problem reported.
- Where: – Where is the problem occurred.
- Why:-Why the problem reported by customer
- How:- How is the problem identified by customer
- How many: – Quantity of effected parts.
Root Cause Analysis
Root cause analysis can be done using various tools like 7QC tools, Fish Bone diagram, 5-Why analysis etc. are used to establish the Root cause(s) for occurrence and detection. It important to find the root cause of both to establish 2 level prevention.
Corrective and Preventive actions
Establish the Corrective and Preventive actions to plug the root cause(s) of Occurrence and Detection. Always emphasize on Poke-Yoke or Error proofing to plug the root cause.
Document the Root cause in PFMEA and update the countermeasure in Control Plan and other relevant documents.
Verification of Countermeasure
Verify the Countermeasures taken physically for actual implementation.
Monitor the effectiveness of countermeasures by checking for similar defect for at least 3 months.