Guides

Root cause analysis

Run a structured 5-Whys, fishbone, or combined investigation, confirm root causes, and drive corrective CAPA to verified closure.

An RCA is a structured investigation that turns a problem into confirmed root causes and corrective actions. It supports 5-Whys, fishbone, and combined methods, and it can link back to the incident, observation, or audit that triggered it.

Start an analysis

  1. Go to RCA and use the Start an analysis form.
  2. Set the site, a title, the method, a problem statement, and an optional target completion date.
  3. Pick a facilitator and an investigation team from the roster.
  4. Optionally choose a source type (incident, observation, audit, inspection, other) and search for the record it came from. Click Start analysis.

Work the investigation

  • Open the analysis to add 5-Whys steps (question and "because…" answer).
  • Record contributing factors by category — the fishbone "6M" set: people, process, equipment, materials, environment, management. Promote any factor to a confirmed root cause, or add root causes directly.
  • Click Raise CAPA on each root cause to drive the fix; the CAPA link then shows on the row.

Complete and verify

  1. Click Complete analysis once at least one root cause is confirmed — tick require a CAPA on every root cause to enforce that before completing.
  2. After completion, record an effectiveness verification (verifier plus note) once every root cause has a corrective CAPA and each CAPA is Completed or Verified — the analysis then shows Verified effective.

What happens automatically

  • Reporting a recordable incident opens an RCA for the case automatically (combined method); you can also start one from the incident page with Start investigation.
  • An open analysis past its target completion date escalates as Investigation overdue.
  • Target completion dates for open analyses appear on the compliance calendar and its .ics feed.

Want to see this working?

Open a sandbox with your industry's data already in it — no signup, nothing to install.

Try it now Talk to us