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 or NCR, ENSURE brings in the root cause and the RCA method used to find it. From an audit, drill or inspection it brings the finding. No retyping, no lost context. The owner can refine the text, and the source stays linked.
- Raised from incidents, NCRs, audits, inspections, drills or observations
- 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 and preventive actions in separate lists, each with owner and due date, plan approved before work starts
- Preventive waiver with mandatory reason for cases where preventive truly doesn't apply
- Linked live to the Actions register: close it anywhere, closed everywhere
Evidence on every action, required if you switch it on.
Attach the signed SOP, the training certificate, the inspection photo, the email from procurement. Switch on the company setting and no CAPA moves to verification until every completed action has a file or a note. ENSURE names the action that is missing it.
- File attachments on every action row (PDF, image, doc) with one click
- Photos auto-compressed before upload so a 4 MB shot lands as 300 KB
- Evidence preserved in the audit trail for the lifetime of the record
Effectiveness review built in, before the CAPA can close.
ISO 9001, 45001 and 14001 all ask you to check that a fix worked. In ENSURE that check is the last step: every action verified, then a decision with evidence and notes, and a review of the risk register. The review date is set at least 30 days after the last action is due. If the answer is "not effective", send the CAPA back for revision or raise a new one linked to it, and the loop continues.
- Review date set at least 30 days after the last action is due (you can change it)
- Actions verified first; decision, evidence and notes required; lessons learned for High and Critical
- "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 keeps a link to the record that raised it, and its actions live in the Actions register, so the auditor can follow the trail 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? +
Once every action is verified, the owner records the decision (effective or not effective), the evidence and notes, lessons learned for High and Critical CAPAs, and reviews the risk register. Effective closes the CAPA. Not effective sends it back or raises a new CAPA linked to it, and the loop continues.
Can a CAPA be linked to multiple sources? +
Yes. A CAPA can be raised from an incident, NCR, audit finding, inspection, drill or observation, and keeps a link back to it. A CAPA that is not effective can raise a successor linked to the original. An MoC can list the CAPAs behind a change in its review.
Is this ISO 9001 / 45001 / 14001 compliant? +
It's built to support it. 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 a notice when an action is assigned, reminders before it is due, and reminders when the CAPA is overdue or its effectiveness review is near, in a morning email summary. Each person chooses in-app, email or both. The dashboard counts overdue CAPAs.
Built for safety-critical industries. Manufacturing · Construction · Logistics · Oil & Gas · Food & Beverage · Healthcare · Facilities
Stop closing CAPAs that don't actually fix anything.
Structured root cause, separate corrective and preventive, evidence on every action, an effectiveness review before closing. Book a 30-minute demo and we'll run your last CAPA through ENSURE so you see exactly what changes.