Close CAPAs that actually close the loop.
Stop closing CAPAs against a textarea and a due date. ENSURE makes the corrective action, the preventive action, the evidence, and the effectiveness review structured data the auditor can walk through on their own.
The CAPA register in ENSURE. Every action owned, dated and tracked to closure.
"CAPA" in most tools means a textarea and a due date.
A real CAPA has a root cause, distinct corrective actions (fix the symptom), preventive actions (stop recurrence), assigned owners, evidence of closure, and an effectiveness check after the dust settles. ENSURE captures all of it as structured data, not as one big "Notes" field someone fills in 10 minutes before an audit.
The root cause flows in from upstream, not rewritten from memory.
When a CAPA is raised from an incident, NCR or audit finding, ENSURE inherits the root cause and the RCA method used to find it. No retyping, no losing context between the investigation and the fix. The owner can refine the text, but the source of truth stays linked.
- Inherited from any upstream record: incident, NCR, audit, drill or MoC
- RCA method (5-Whys, Fishbone, Fault Tree, FMEA, Direct Observation) preserved alongside the cause
- Editable by the CAPA owner, with full revision history kept for the auditor
Corrective and Preventive, in separate lists. Waive the preventive when it doesn't apply.
Every action gets a named owner from your user directory, a due date, a status, and syncs live with the central Actions register. Most tools force a preventive action even when one doesn't make sense, so people invent something. ENSURE lets you waive it with a required written reason that stays in the audit trail.
- Corrective actions and preventive actions tracked in separate sections, both with owner + due date + evidence
- Preventive waiver with mandatory reason for cases where preventive truly doesn't apply
- Bidirectional live sync with the Actions register, close it anywhere, closed everywhere
Evidence is required on every action before the CAPA can close.
Attach the signed SOP, the training certificate, the inspection photo, the email from procurement. Without evidence on each completed action, the close button doesn't light up. No more "we'll add the evidence later" CAPAs that never get evidence.
- File attachments on every action row (PDF, image, doc) with one click
- Photos auto-compressed before upload
- Evidence preserved in the audit trail for the lifetime of the record
Effectiveness review baked in, with a real wait period.
ISO 9001, 45001 and 14001 all require an effectiveness review after the CAPA closes. ENSURE waits a configurable period (default 30 days) before letting anyone mark it "effective", because you can't measure if a fix worked until time passes. The review captures criteria, decision, notes, and an evidence URL. If the answer is "not effective", ENSURE prompts you to send the CAPA back for revision or raise a fresh one on the spot. The loop continues.
- Configurable minimum wait period before review can be marked complete (default 30 days)
- Structured fields: criteria, decision (effective or not), notes, evidence URL, lessons learned
- "Not effective" offers one click to revise or raise a successor CAPA. The link back to the original is kept
A CAPA is rarely the start, never the end.
A CAPA sits in the middle of a longer trail. It's raised by something upstream and feeds something downstream. The links are preserved on both sides so the auditor can walk the trail in either direction without your help.
What QHSE Managers ask us first.
Our CAPAs always close late. How does this help? +
Every action gets a named owner from your user directory, a due date, and a status, and syncs live with the central Actions register. The assignee finds their CAPA work next to actions raised from incidents, NCRs, audits and MoCs, in one filterable list. No more "I didn't know it was on my plate".
What if we don't have a preventive action that makes sense? +
Tick the Preventive Waived box and write the reason. ENSURE keeps the waiver as part of the audit trail, so the auditor sees that you considered preventive action and made a deliberate decision, not that you forgot it.
How does the effectiveness review actually work? +
After the CAPA closes, ENSURE waits a configurable period (default 30 days) before letting anyone mark it "effective". The review prompts for criteria, decision (effective or not effective), notes, and an evidence URL. If it's not effective, you spawn a new CAPA, the loop continues.
Can a CAPA be linked to multiple sources? +
Yes. A CAPA can be raised from an incident, NCR, audit finding, drill or MoC, and the same CAPA can later spawn an MoC if the fix needs formal change control. Every link is preserved on both sides, your auditor can walk the trail in either direction.
Is this ISO 9001 / 45001 / 14001 compliant? +
It's built to support ISO 9001 / 45001 / 14001 conformance. The CAPA structure (root cause, corrective, preventive, evidence, effectiveness review) maps to the requirements of ISO 9001 clause 10.2, ISO 45001 clause 10.2, and ISO 14001 clause 10.2 on nonconformity and corrective action. The Legal Register module tracks per-clause compliance with evidence.
What about reminder notifications to the action owner? +
Owners get notifications when an action is assigned, when it's overdue, and when the CAPA effectiveness review is due. Notifications can be in-app, email, or both, per user preference. Org-wide admins also see overdue actions on the dashboard.
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Stop closing CAPAs that don't actually fix anything.
Structured root cause, separate corrective and preventive, mandatory evidence, effectiveness review with a real wait period. Book a 30-minute demo and we'll run YOUR last CAPA through ENSURE so you see exactly what changes.