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ClearVue CAPA
From nonconformance to verified fix — fully documented.
A corrective action lifecycle that supports ISO 9001 §10.2: intake, triage, root cause analysis, action planning, implementation and effectiveness verification. Every stage is timestamped and attributed. CAPA is one module, on Growth and above. The fishbone builder and recurrence metrics are part of it today, with 8D and linked Change Control to follow.
Key Capabilities
- ✓ Triage gate with 3×3 risk scoring to set priority; a minor finding can be closed with a correction and no full CAPA, with the reason recorded (ISO 9001 §10.2.1 b)
- ✓ Root cause analysis with a 5-Why builder, or free text
- ✓ Containment, corrective and preventive actions, kept distinct
- ✓ Actions assigned to a position, so ownership survives personnel changes
- ✓ Effectiveness verification due by severity: 30 to 90 days by default, and you can change it
- ✓ A CAPA cannot close until its latest verification is recorded as Effective
- ✓ Training can be a CAPA's corrective action: once an action-level effectiveness check is scheduled on the linked training, the CAPA cannot be recorded as effective until the latest such check is
- ✓ My CAPA Actions worklist for the people who own actions
- ✓ Compliance dashboard: open, overdue and by stage
- ✓ A CAPA opens automatically from an inspection finding at your severity threshold, or when an asset is taken out of service
- ✓ Auto-numbering, stage notes and a locked closure record
- ✓ Fishbone (Ishikawa) root-cause builder
- ✓ Reopen and recurrence metrics, with a repeatedly reopened CAPA flagged as chronic
Coming next
- The 8D root-cause method
- Linked Change Control on corrective actions
ISO 9001 Clause 10.2: what the standard asks for, and where CAPA fits
Clause 10.2 asks you to deal with each nonconformity when it happens, decide whether its cause needs removing so it does not come back or turn up elsewhere, act on that decision, check that the corrective action worked, and where needed revisit the risks and opportunities you planned for and change your quality management system. Clause 10.2.2 asks you to keep a record of what went wrong, what you did about it, and how any corrective action turned out. ClearVue CAPA keeps that record in one place, and a CAPA cannot close until its latest effectiveness verification is recorded as Effective.
Works With
See CAPA in Action
Request a live demo and we will walk you through exactly how this module handles your ISO 9001 requirements.