Signal detected · 1 / 6A recurring defect crosses its trend threshold and raises a quality signal.
QMS story: From factory signal to a controlled QMS record
Convert repeat defects into corrective-action evidence and management insight.
Step 1 of 6 — Signal detected. A recurring defect crosses its trend threshold and raises a quality signal.
Step 2 of 6 — Evidence sealed. Inspection image, measurement, and operator note are bound and sealed as evidence.
Step 3 of 6 — QMS record prepared. The system prepares a nonconformance and a linked corrective-action draft.
Step 4 of 6 — Human decision required. QA review is required before any disposition. No automatic disposition.
Step 5 of 6 — Signature recorded. The QA lead records a signature; the corrective action becomes a controlled record.
Step 6 of 6 — Audit packet prepared. An audit packet is prepared with an ISO 9001 evidence view; gaps stay visible.
Approval: The system prepared an NCR and a CAPA draft from the sealed evidence. Quality lead must approve. Human approval required before any disposition. No automatic disposition.
Readiness — ISO 9001 evidence-readiness view: Nonconformance evidence (evidence complete); Corrective-action linkage (evidence complete); Effectiveness check (gap remains). Readiness reflects evidence on hand — gaps stay visible until the effectiveness check is recorded.
HoldField prepares the evidence and records; QA owns the disposition and the effectiveness review.