Workflow

Flow 18 — Product escape, recall and affected-product tracing

Trace an escaped exact material identity into delivered product units, independently approve the affected scope, decide product-safety response, account for external obligations and verify closure.

Overview

Inventory meaning

Flow 18 creates Quality, genealogy snapshot and controlled-evidence records only. It never sends a customer/authority message; blocks, moves, releases, returns or recalls stock; or changes product-unit delivery, released baseline or supplier approval state.

Responsible roles

Quality Engineer → different QA Head → different Product Safety Manager → different Project / Contract Manager → QA Head → read-only stakeholders

Process

1
Contained escape NCR
Start from one open contained S1/S2 nonconformance with exact affected identity.
Linked Quality fact · custody unchanged
2
Scope & genealogy
Trace batch/serial through retained as-built output links to serialized product units.
Read-only genealogy · no stock action
3
QA scope review
Reject for immutable replacement or approve risk, completeness and population.
Independent assurance gate
4
Safety decision
Assign one product disposition and accountable obligations as a separate actor.
Decision only · no recall execution
5
External evidence
Record references/evidence for actions performed in their authoritative channels.
No Moduvio message or custody transaction
6
Verified closure
Close after all products/obligations and the linked NCR/CAPA are final.
Read-only assurance chain
READ ONLY

Role handoff

Quality Engineer → different QA Head → different Product Safety Manager → different Project / Contract Manager → QA Head → read-only stakeholders

Detailed reference chapters

Product escape, recall and affected-product accountability Nonconformance and CAPA governance Product configuration and released baselines traceability Controlled documents and evidence

Detailed steps

1
As Quality Engineer, open Quality → Product escapes & recall, select an open contained S1/S2 NCR, define the trigger, risk, population, exact trace item plus batch/serial and completeness, attach CLEAN evidence and run the retained as-built genealogy trace.
2
Submit scope v1. As a different QA Head, reject it and confirm its candidates/evidence remain immutable. Create and submit scope v2, then approve its complete delivered-product population and active response proposal.
3
As a separate Product Safety Manager, assign exactly one disposition to every product unit and create accountable customer, authority, supplier, programme or field-action obligations. Critical, safety or regulatory risk cannot be monitoring-only; regulatory impact requires an authority-reporting obligation.
4
As a separate Project / Contract Manager, record external action/acknowledgement references and CLEAN evidence for every unit and obligation. Confirm the actions occurred outside Moduvio: the screen sends no message and performs no custody transaction.
5
Attempt QA closure while the linked NCR/CAPA remains open and confirm it is blocked. Close the NCR/CAPA separately in Flow 13, then verify full product accountability and close Flow 18 with residual-risk evidence.
6
As Configuration Manager or Auditor, reconcile the exact genealogy path, immutable scope versions, four distinct actors, evidence links, audit/outbox chronology and unchanged stock, product-unit, baseline, supplier and notification-delivery state.

Field-by-field practice data

Use a disposable training tenant

Define the exact affected population for one contained training product escape. The page shows sample set A; the workbook includes independent A, B and C values.

Download all workflow samples (.xlsx)

Field names match the current application labels. Select existing approved records where shown, leave optional values blank unless they genuinely apply, and never copy fictitious TRAIN values into live work.

Quality Engineer

Create the escape scope

Open /quality/product-escapes

Select the contained source and freeze the exact product-unit population from genealogy.

Exact field name	Requirement	Sample value A	How to use it
Contained S1/S2 NCR	Select existing	`TRAIN-A-NCR-ESC-001`	Select the exact contained source.
Scope title	Required	`TRAIN-A actuator escape population`	Use a factual, bounded title.
Detected on	Required	`2026-09-08`	Record the detection date.
Trigger	Required	`CUSTOMER_REPORT`	Select the actual trigger.
Trigger reference	Required	`TRAIN-A-CUSTOMER-REF-001`	Use the authoritative external or internal reference.
Scope and trace evidence	Select existing	`TRAIN-A-TRACE-PACK-001`	Select CLEAN controlled evidence.
Scope submission note	Required	`Genealogy traced from affected component lot to three training product units.`	Explain the deterministic scope basis.

Expected result: A different QA Head approves scope and Product Safety decides obligations; Moduvio does not send messages or move custody here.

End state

One closed product escape retains exact genealogy-backed affected-product accountability, an independently approved scope, separate Product Safety response, externally evidenced obligations and closed NCR/CAPA provenance without acquiring messaging, custody or configuration authority.