Short answer: A correction fixes the specific problem found. A corrective action removes the cause so it does not happen again. Root cause analysis is how you find that cause. Auditors expect all three, plus evidence, and they look for causes in the system rather than in individuals.
Three different things
- Correction: deal with the instance, including product already released. For example, quarantine and re-screen affected stock.
- Root cause: why the system allowed it to happen.
- Corrective action: change the system so the cause is removed, here and wherever the same cause could apply.
A worked 5-Why example
- Why were rejected packs re-run? Operators thought rejects were false alarms.
- Why? The reject procedure was only in English and posted in the day-shift office.
- Why? Night-shift staff were never trained on it.
- Why were missing checks not noticed? Quality reviewed only day-shift records.
- Why? Controls were designed assuming day-shift supervision. That is the root cause.
What a strong response looks like
- Covers product already shipped, not only stock on site.
- States a cause that explains every symptom found.
- Changes the system (instructions, training, checks, verification), not just "retrain operator".
- Extends to similar lines, shifts and sites.
- Includes evidence over a meaningful period, with owners and dates.
Weak responses auditors reject
- "Human error" as the root cause.
- Restating the nonconformity as the cause.
- A corrective action with no date, owner or evidence.
Next step
The difference between fixing the problem and fixing the system, with a worked 5-Why example and what auditors look for in a response.
How BVS reviews corrective actions
