Workflow

Flow 13 — Nonconformance, root cause and CAPA acceptance

Raise and contain one attributable nonconformance, assign an independent investigation, govern disposition, complete corrective action, verify sustained effectiveness and close with a complete evidence chain.

Overview

Inventory meaning

Quality records never create, move, block, release or adjust inventory. Exact stock may be referenced only when it is already BLOCKED or MRB_HOLD. Any material disposition must use the separately approved and executed MRB path; a process NCR remains zero-stock end to end.

Responsible roles

Quality Inspector → different QA Head → different Quality Engineer → QA Head → Quality Engineer → independent QA Head → Auditor

Process

1
Open NCR
Identify one affected object, source, severity, defect and due containment.
Quality fact · Inventory unchanged
2
Contained
Prove scope control and immediate correction with CLEAN evidence.
Containment fact · Inventory unchanged
3
Investigation
Different QA Head confirms triage and assigns a separate Quality Engineer.
Assignment · Inventory unchanged
4
Disposition pending
Engineer submits root cause and any completed matching MRB decision.
Decision pending · no stock authority
5
Action in progress
Independent approval opens controlled corrective/preventive action work.
CAPA work · Inventory unchanged
6
Verification
All actions are complete and an independent user tests sustained effectiveness.
Effectiveness gate · Inventory unchanged
7
Closed
QA accepts residual risk and notification evidence; Auditor reads the chain.
Closed Quality record · Inventory unchanged

Role handoff

Quality Inspector → different QA Head → different Quality Engineer → QA Head → Quality Engineer → independent QA Head → Auditor

Detailed reference chapters

Nonconformance and CAPA governance Inbound inventory — Inspection, release and putaway Codification, DGQA/DGAQA, ownership, costing and MRB Controlled documents and evidence

Detailed steps

1
As Quality Inspector, open Quality → Nonconformance & CAPA and raise a PROCESS NCR with one exact affected reference, occurrence date, severity, detection context and containment due date.
2
Record immediate containment using an ACTIVE, CLEAN controlled document version. Confirm QA Head cannot perform the inspector's containment step and that the Quality record itself posts no stock movement.
3
Confirm the originator cannot triage their own NCR. Sign in as a different QA Head, confirm severity and notification need, set the investigation due date and assign a separate eligible Quality Engineer.
4
As the assigned Quality Engineer, submit root cause, contributing factors, escape point, correction, recurrence risk and disposition with CLEAN evidence. Use NO MATERIAL DISPOSITION for the process test; any physical disposition must link a matching completed MRB case.
5
Confirm the Quality Engineer cannot approve their own investigation. As QA Head, independently approve it or reject it for revision with an attributable note.
6
As Quality Engineer, add at least one CORRECTIVE action with owner, due date and objective verification criteria, then complete every action with evidence. Confirm the NCR reaches VERIFICATION only when all actions are complete and a corrective action exists.
7
Confirm the investigation owner/action executor cannot verify effectiveness. As QA Head, record an independent method, observed result and acceptable or monitored residual risk; an ineffective result returns the NCR to ACTION IN PROGRESS.
8
Close only after the latest effectiveness review is EFFECTIVE and any required customer/authority notification reference exists. As Auditor, read the full chain and reconcile unchanged current stock and stock ledger.

Field-by-field practice data

Use a disposable training tenant

Raise and contain one medium-severity supplier-linked NCR, then route it for independent triage. 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 Inspector

Create the NCR

Open /quality

Choose the exact affected boundary and describe the observed nonconformance before recording containment.

Exact field name	Requirement	Sample value A	How to use it
Site	Select existing	`COM-01`	Select the affected site.
Affected object	Required	`ITEM`	Choose the exact domain boundary.
Source	Required	`INCOMING_INSPECTION`	Use the actual detection source.
Severity	Required	`S2`	Select evidence-backed severity.
Defect category	Required	`DIMENSIONAL`	Use the governed defect taxonomy.
Occurrence date	Required	`2026-09-05`	Record when the issue occurred or was detected.
Classification	Required	`RESTRICTED`	Match the evidence sensitivity.
NCR title	Required	`TRAIN-A bolt thread dimension outside tolerance`	Use a concise factual title.
Affected reference	Required	`TRAIN-A-LOT-001`	Reference the exact batch or serial.
Nonconformance description	Required	`Thread major diameter measured outside TRN-DWG-01 tolerance at incoming inspection.`	State objective facts, not an assumed cause.
Detection context	Required	`Incoming sample inspection at QUAR-01 using calibrated gauge.`	Identify where and how it was found.

Expected result: The NCR is attributable; Quality records do not silently move or release inventory.

End state

One closed NCR retains attributable detection, containment, triage, investigation, approval, CAPA, independent effectiveness and closure evidence without granting Quality autonomous inventory authority.