Signal detected · 1 / 6An incoming-lot defect cluster raises a supplier-risk signal.
QMS story: See supplier risk from evidence, not spreadsheets
See supplier risk from evidence, not spreadsheets.
Step 1 of 6 — Signal detected. An incoming-lot defect cluster raises a supplier-risk signal.
Step 2 of 6 — Evidence sealed. Incoming-inspection results and the supplier certificate are bound and sealed.
Step 3 of 6 — QMS record prepared. A SCAR is drafted and a supplier-response packet with a CAPA link is prepared.
Step 4 of 6 — Human decision required. Supplier-quality approval is required before the SCAR issues — no automatic disposition.
Step 5 of 6 — Signature recorded. The reviewer records a signature; the supplier action becomes a controlled record.
Step 6 of 6 — Audit packet prepared. An audit packet shows a supplier-quality evidence view with the risk trend.
Approval: The system drafted a SCAR and a supplier-response packet from the lot evidence. Supplier-quality engineer must approve. Human approval required before any disposition. No automatic disposition.
Readiness — Supplier-quality evidence view: Incoming-inspection evidence (evidence complete); Supplier certificate (evidence complete); Supplier response (gap remains). A supplier-quality evidence view — risk from bound evidence, with the open response still visible.
HoldField prepares the SCAR; supplier quality owns issuance and approved-supplier status.