You're looking at a nonconformity report. A batch came back out of spec, or a complaint just landed, or an inspector flagged a mislabeled carton. Somewhere between "we should fix this" and "we should open a CAPA," you have to make a call that a surprising number of good quality teams get wrong.
Do you correct it, or do you open a corrective action?
If you open a full corrective action for every hiccup, your corrective and preventive action (CAPA) log balloons, your investigators drown, and the one issue that actually threatens a patient waits in the same line as a smudged label. Open too few, and the same defect keeps coming back until an investigator writes it up for you.
There's a close cousin to this question that people mix it up with, which is when a nonconformance should become a CAPA at all. I wrote about that decision separately, and it's a different call. This one is just a bit deeper. Because once you've decided to act, does the action stop at a correction, or does it graduate into a corrective action?
A correction is when you fix the thing right in front of you. That may mean reworking the unit, re-inspecting the lot, scrapping it, or replacing it. The correction eliminates the nonconformity you detected, and that's how ISO 9000, the vocabulary standard that the Quality Management System Regulation (QMSR) now leans on, defines it: action to eliminate a detected nonconformity.
A corrective action goes after the root cause. You run a root cause analysis, then you change something so the nonconformity stops happening. That's ISO 13485 clause 8.5.2, and it has a proactive sibling, preventive action under 8.5.3, which I've broken down in a separate piece on when to reach for each.
This is the distinction. A correction fixes the thing. A corrective action fixes the reason the thing happened. Every corrective action begins with a correction, and the reverse is simply not true.
One precision note, because words are incredibly important in our industry. In recall language, under 21 CFR Part 806, "correction" means something else entirely, namely repairing or adjusting a device in the field instead of pulling it off the market. It's the same word, but in a completely different universe. When I say correction in this article, I mean the quality-system sense: the immediate fix to a detected nonconformity, not a reportable field action.
The timing on all of this matters more than it used to. As of Feb. 2, 2026, the QMSR is in effect, and 21 CFR Part 820 now runs on ISO 13485:2016. The Food and Drug Administration (FDA) speaks the ISO vocabulary now, right down to correction, corrective action, and preventive action as separate clause-level ideas. A Form 483 written today frames its observations in those terms, so getting the distinction right is less a matter of taste and more how your inspection reads on paper.
Over-escalation. As an ISO 13485 lead auditor, the first thing I check when I open a CAPA log is the age of the oldest open item. A stack of corrective actions opened for one-off, already-contained corrections tells me the system can't tell something minor from something major. Your investigators burn a week writing root cause analyses for problems that had an obvious, contained special cause, while the actual systemic issue sits in the exact same pile waiting its turn.
Under-escalation. The opposite does even more damage. The same nonconformity gets corrected again and again, rework after rework, and nobody ever opens the corrective action that would kill the cause. Each individual fix looks perfectly reasonable in isolation. The trend is what should be the dead giveaway. When an investigator pulls your nonconformance history and finds the same defect five times, with five corrections and zero corrective actions, you've just handed them a finding.
→ BONUS RESOURCE: Grab the 5-step checklist for deciding whether a CAPA is required.
Start from a fixed point: every nonconformity gets a correction first. You always contain and fix the immediate problem. The real decision is whether that correction earns a corrective action stacked on top of it. Five questions settle it most of the time.
Score a nonconformity as first-time, low-risk, known-cause, contained, and single-unit, and a correction with a clear note in the record is usually enough. Push more than one or two of those toward recurring, higher-risk, unknown-cause, and systemic, and you're looking at a corrective action whether you like the paperwork or not.
Look again at those five questions and notice how many are really data questions. Is it recurring? Is there a trend across lots or complaints? You can only answer honestly if your nonconformances, complaints, and CAPAs live in one place and actually talk to each other. Spread them across a shared drive and a stack of spreadsheets, and the trend is going to stay invisible, or the FDA finds it for you.
Greenlight Guru's quality platform connects nonconformance, complaint, and CAPA records with trending built in, so the escalation decision runs on evidence instead of somebody's memory of "didn't we see this before?" When the same defect surfaces a third time, the system surfaces it too, and the correction-or-corrective-action call starts to make itself.
→ BONUS RESOURCE: Work through the full CAPA for medical devices guide for the end-to-end process.
If you're building out your CAPA decision-making process, these related guides go deeper on the specific pieces:
If your CAPA log is either badly bloated or suspiciously silent, that's usually a sign the correction-versus-corrective-action decision is getting made by gut instead of by framework. See how Greenlight Guru handles it.