Quality
CAPA & Nonconformance Management for regulated manufacturers
From nonconformance identification through root-cause analysis, action plan, implementation, and effectiveness verification — fully governed, fully signed, audit-ready from day one.
CAPA state machine
Each stage can also transition to Cancelled (terminal). Closed is terminal.
Root-cause method tracking
Every CAPA records the root-cause analysis method: 5-Why, Fishbone (Ishikawa), or Fault Tree. The method is required before transitioning to Action Plan — auditors expect to see a named methodology, not a free-text note. Root-cause narratives are stored in the immutable CAPA record alongside the method choice.
Gated transitions with e-signatures
Three transitions require electronic signatures per 21 CFR Part 11 §11.50: Plan Approved (before Implementation), Implementation Complete (before Effectiveness Verification), and CAPA Closed. Signing meaning is captured explicitly — not just a password confirmation.
Action items with ownership and due dates
CAPAs contain one or more action items, each with an owner, due date, and completion status (Open / InProgress / Complete / Cancelled). The transition to Effectiveness Verification is blocked until all action items are Complete or Cancelled — preventing premature closure.
Effectiveness verification
Effectiveness verifications record objective evidence that the corrective action worked. At least one verification with result "Effective" is required before a CAPA can close. This satisfies the effectiveness check requirement in ISO 13485 §8.5.2 and 21 CFR 820.100.
NC trend thresholds with auto-CAPA creation
Configure rolling-window thresholds per part or process: if nonconformance count exceeds the trigger in the window, a CAPA is created automatically and linked to the threshold. Very few MES vendors offer native trend-based CAPA initiation — this is typically a manual process that depends on someone noticing the pattern.
Nonconformance lifecycle
Nonconformances flow through Identified → Segregated → Dispositioned → Closed. Disposition options: UseAsIs, Rework, Scrap, ReturnToSupplier, DeviatePending. Rework CNCAs link to a follow-up work order; Scrap events post to inventory. Every state transition is timestamped and signed where required.
Regulatory mapping
| Standard | Clause | Qontiv feature |
|---|---|---|
| ISO 13485 | §8.5.2 / §8.5.3 | CAPA state machine + effectiveness verification |
| 21 CFR Part 820 | §820.100 (QMSR §820.100) | CAPA procedures with root-cause and effectiveness |
| IATF 16949 | §10.2 | Nonconformance + CAPA workflow |
| AS9100 Rev D | §10.2 | CAPA with documented root-cause analysis |
Close your CAPAs on time. Every time.
State-machine governance, e-signatures, trend thresholds — CAPA that satisfies 21 CFR 820.100.