Inconsistent Terminology

Many of the problems (findings) with CAPA systems arise from inconsistent use of terminology.

Corrections & Corrective Actions

While there, unfortunately, aren’t standard definitions, we’ll put a stake in the ground for this discussion. Throughout this discussion, we’ll (try) to use:

• Corrections: those actions taken to resolve problems. For example, if we have a circuit board with a blown capacitor, replacing that capacitor is a correction. If we have a software bug that allows an invalid value to be entered by a user, the change for that immediate issue is a correction.
• Corrective Actions: those actions taken to stop the problem from occurring.

Corrective Action Example

Using these examples, we may find that the capacitors from a certain supplier aren’t as reliable so we’ll only use resistors from a supplier that has better reliability. The programmer that wrote code to allow an invalid entry may need to be trained on programming practices to always validate entries before accepting.

Preventative Action

Preventive Action: those actions taken to prevent the problem from recurring.

Preventative Action Example

Maybe the capacitor selected was on the edge of the rating needed for the particular application and a peer review would have detected the likelihood of failure earlier. For software development, maybe implementing coding standards and peer reviews would have helped avoid the problem.