What to check in your CAPA log before an audit

Empty or placeholder fields

Look for lines with no owner, and closed lines with no effectiveness entry or no link to their evidence. Treat a placeholder such as "tbd", "n/a", "pending" or a dash the same as an empty cell, since it tells a reader no more.

Due dates and closed dates

An open line without a due date is worth a check, and so is an open line past its due date. A closed line is worth a closed date, so you can show the order of events. Dates typed with slashes, where day and month could swap, are worth rewriting in one clear format so nobody reads them wrongly. If 3 or more (our own cut-off, not from a standard) open lines share the very same due date, check whether that date was planned or is a placeholder nobody changed.

Closed without proof that it worked

Closing an action shows it was done, not that it worked. A closed line is worth a check when the effectiveness entry is empty, or when it was closed before the effectiveness data came in. The CAPA effectiveness check guide shows what that evidence can look like.

Cause and action wording

A cause that contains words such as "operator error", "human error", "training" or "unknown" is worth a second look, and so is an action that consists of training only, such as "Operator retrained". Be honest with yourself about what this kind of review is: a keyword check reads the words, not the meaning. A cause can be sound and still use one of these words, or be weak without them. A keyword check also misses training-only actions that are worded differently, so read each line yourself.

Old open lines and duplicate IDs

Set your own limit for how long an action may stay open, and check the lines that are older. Also look for the same CAPA ID on more than one line, because it then becomes unclear which record is the real one.

Run these checks on your log file

The free CAPA log health check runs 12 fixed rules, close to the checks above, on the first sheet of your .xlsx or .csv log. It is a rule-based keyword check, with no AI, and it lists rows worth a check, not audit findings. The tool page says: "Your file is read in your browser and is not uploaded to our server."

CAPA or 8D?

If your log mixes CAPA lines and full 8D reports, see CAPA vs 8D for how the two fit together. For new entries, the CAPA form template has fields for owner, dates, evidence and effectiveness.

Advisory guide, in our own words. Not an audit result or a certification body opinion.