IncidentLiveThe CAPA report, drafted from the incident.
A CAPA report has to show what went wrong, why, what you did about it and that it worked. IncidentLive drafts it from the timeline the incident was handled on, with a source behind every statement, and keeps the effectiveness check open until there is proof.
What is CAPA?
CAPA stands for corrective and preventive action. It is how a quality management system deals with a problem for good: find the cause, remove it, and stop the same or a similar problem from happening elsewhere. ISO 13485 requires it from medical device makers, the EU MDR expects it as part of their quality system, and food standards such as IFS Food ask for corrective actions with their cause and a check that they worked.
Correction
Fixes the problem in front of you: the faulty batch is blocked, the line runs again. The cause is still there.
Corrective action
Removes the cause of a problem that has happened, so that it doesn't happen again.
Preventive action
Removes the cause of a problem that hasn't happened yet, for example on other lines, products or sites.
The CAPA process, step by step
Every CAPA report answers the same questions in the same order. For each step, here is what it asks for and what IncidentLive takes from the timeline.
What IncidentLive fills in from the timeline
- 1
Problem description
What happened, which products, batches or customers are affected, and since when.
IncidentLive fills in: The title, severity, time window, the first report and the linked tickets. Affected products and batches become a to do if the timeline doesn't name them.
- 2
Investigation
What was checked, and what was found.
IncidentLive fills in: The observations and findings from the timeline, including what coding agents reported, each with its time.
- 3
Root cause
The proven cause, not the first idea.
IncidentLive fills in: Only a cause a person has confirmed. Hypotheses stay marked as hypotheses.
- 4
Correction
What was done right away to contain the problem.
IncidentLive fills in: The workarounds, restarts, rollbacks and other immediate measures from the timeline.
- 5
Corrective action
The permanent fix for the cause, with an owner and a date.
IncidentLive fills in: The confirmed follow-ups that change code, configuration or capacity, with their tickets.
- 6
Preventive action
What stops a similar problem somewhere else.
IncidentLive fills in: The confirmed follow-ups for monitoring, tests, processes and documentation.
- 7
Effectiveness check
Evidence that the actions worked, after enough time has passed to tell.
Never marked done on its own. It stays open until someone adds the evidence.
How IncidentLive drafts the CAPA report
The draft comes from the incident's own timeline: tickets, alerts, notes, files and what coding agents reported, in the order it happened. Nothing goes into the report that the timeline doesn't say.
Every point has a source. The proof stays open until it exists.
Each point links to the timeline entries it comes from, so an auditor can follow it back to the original. What the timeline doesn't say becomes a to do for a person.
- Nothing is made up to make the report look complete
- A hypothesis stays a hypothesis until someone who manages the incident accepts it
- The timeline only grows: a wrong finding is retracted with a new entry, never deleted
Approved by people, ready for your quality system.
Your team confirms or rejects each point and adds what is missing. A reviewer adds notes, sends the report back or approves it.
- By default nobody approves a report they submitted themselves
- Until approval every page of the PDF says it is not approved yet
- The approved PDF goes into your quality management system like any other record
Want to see your next CAPA drafted like this?
Become a pilot teamQuestions about CAPA
When is a CAPA needed?
When a nonconformity, a complaint, an audit finding or an incident shows a problem in a product or process that could come back. Medical devices, pharma and food have to document it; other industries use CAPA because it works.
What is the difference between a correction and a corrective action?
A correction deals with the problem that is there now, for example by blocking a faulty batch. A corrective action removes its cause, so that it doesn't happen again. A CAPA report needs both, and says which is which.
Does IncidentLive replace our quality management system?
No. IncidentLive drafts the report from the incident, and your team checks and approves it. The approved report then goes into your quality management system.
Does the AI decide the root cause?
No. The report only names a cause that a person has confirmed. Before that, it says the root cause is not yet confirmed.
What is the difference between CAPA and 8D?
Both describe a problem, its cause and what was done about it. CAPA is common in medical devices, pharma and food, 8D in the car industry. IncidentLive drafts both from the same timeline: more about the 8D report.
Three reports, one timeline
8D report
For carmakers and their suppliers, and anyone whose customers ask for 8D.
- IATF 16949
- VDA
NIS2 reports
For companies that fall under NIS2: the early warning, the incident notification and the final report.
- NIS2
- BSI
CAPA report
For medical devices, pharma and food, with an effectiveness check that stays open until there is proof.
- ISO 13485
- EU MDR
- IFS Food
This page
Let's try it with your incidents.
We're looking for a few pilot teams. If writing up CAPAs keeps your quality team busy long after the problem is fixed, tell us about your setup and we'll get IncidentLive running with you.
- You write or callTell us which tools you use and how incidents run for you today.
- We set it up with youOn your own servers, connected to the tools your team already uses.
- Your team tries it on real incidentsAnd the next CAPA report starts from the timeline, not from an empty form.