Quick CAPA Tips:

Step 1—Know the Difference: Make sure you and your team understand the difference between a corrective action and a preventive action. While they can be handled within the same system, one is reactive (corrective) while the other is pro-active (preventive).

Step 2—Define and Confirm: Peel back the problem layer by layer to get to the root cause. Using an iterative question-asking technique such as the “five whys” can help you determine what you truly need to investigate (e.g., materials, personnel, tooling, etc.) and what the extent of the problem is(e.g., in-house, in the supply chain, out in the field, etc.).

Step 3—Contain: Once you’ve determined the true problem, it’s important to contain it and keep it quarantined so no other products go out with issues or problematic processes don’t continue.

Step 4—Document: Keep records that have sufficient detail and a clear description of the issue so that the information isn’t based on tribal knowledge.

Step 5—Follow-up: In addition to verifying to ensure that corrections were made, follow-up at a later date to determine whether or not those corrections worked in the long term.