Can HublerX trigger a CAPA from a customer complaint, not just a quality hold?

Yes. CAPAs can be triggered from quality holds, customer complaints, internal audit observations, supplier quality failures, regulatory notices, and manual raises by the quality team. The source is recorded and linked to the CAPA record for traceability.

How does HublerX manage CAPAs that require actions across multiple departments?

Where a CAPA requires actions from multiple functions — quality, production, procurement, maintenance — each action is assigned to the responsible owner with its own deadline and tracked separately. The CAPA cannot be closed until all assigned actions are complete and the effectiveness check is passed.

What happens when a CAPA is overdue?

HublerX sends deadline reminders to the action owner at configured intervals before the due date. If the action is not updated by the deadline, the CAPA is escalated to the quality manager and plant manager automatically. Escalation history is recorded in the CAPA audit trail.

Can the effectiveness check criteria be customised per CAPA type?

Yes. Effectiveness check criteria, timing, and evidence requirements are configured by CAPA category. A process change CAPA may require 5 consecutive compliant production batches as evidence. A supplier CAPA may require 3 consecutive compliant deliveries. The criteria are defined when the corrective action is set and verified at the scheduled check.

CAPA Management Workflow

HublerX manages the full CAPA lifecycle — from quality finding to root cause investigation, corrective action assignment, effectiveness verification, and regulatory closure — with automated follow-up, deadline tracking, and a complete audit trail at every step.