What it produces
Complete NCR and CAPA records, stock held before anyone uses it, and corrective actions tracked to closure.
Workflows
Nonconformance to CAPA
the process of recording a product failure, deciding its disposition, and opening corrective and preventive action to stop it recurring
The job in one minute
Who owns it
The quality manager, with supplier quality, engineering, operations, inventory control and purchasing.
How often
Every failed inspection, complaint or supplier rejection.
Why it hurts
A CMM report fails a bore diameter. An inspector writes a tag. Someone types the NCR two days later with half the fields, while the suspect parts still sit in a bin marked good and the lot number lives only on the tag. The board's decision ends up in meeting notes. Six weeks later the same defect on the same part opens a brand new NCR because nobody checked history.
These records are not optional. ISO 9001 asks for the nonconformity, the action taken, any concession and who decided. For medical devices, ISO 13485 sets the same bar.
Systems it touches
Where the QMS lives apart from the ERP, the agent works both screens and keeps them in step. It reads inspection exports by column header, so a reordered report does not break it. Product →
- ERP
- QMS (built-in or standalone)
- CMM and gauge software
- Vision system logs
- Outlook
- Excel
- SharePoint or OneDrive
12 steps · 5 actions · 4 decisions · 3 human reviews
The workflow, step by step
Action Decision Human review Select a step in the flowchart to jump to it.
1Contain steps 1–6
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Action · Agent
Collect signals: failed inspections, MRB tags, customer complaints, supplier rejections at receiving. Read part, revision, lot, quantity, characteristic, measured value and who found it.
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Decision · Agent
Is the measured value outside the inspection plan limits? Inside means no NCR.
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Decision · Agent
Same part, lot and defect already open? Append to it instead of creating a duplicate.
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Action · Agent
Create the NCR with every required field, move the stock to hold and read back that it shows as blocked.
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Decision · Agent
Open a CAPA if the defect repeats within your look-back window, involves a customer complaint or hits a critical characteristic.
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Human review · Board
The material review board picks the disposition: use as is, rework, repair, scrap or return to supplier. The authority table says who may approve each.
2Correct steps 7–12
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Action · ERP
Run the disposition in the ERP (scrap, rework order or supplier return) and verify it.
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Action · Agent
Open the CAPA with an evidence pack: related NCRs, a defect chart for the part, affected lots, process and gauge data. Anything the model summarized is marked draft.
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Human review · The
The CAPA team decides root cause and actions. The agent never writes root cause.
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Action · Agent
Send reminders as actions come due and escalate overdue ones to the quality manager.
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Decision · Agent
No recurrence across your verification window proposes closure. Any recurrence reopens the CAPA.
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Human review · Quality manager
The quality manager closes the CAPA.
✓ Done
See it done in the Gallery
Rules vs judgment
The root-cause fields cannot be written by the agent, and the person who owns an action cannot close the CAPA.
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Exact rule
- In or out of spec, CAPA triggers, due dates, escalation, effectiveness check
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Model reads
- Handwritten MRB tags and complaint emails; grouping similar defect descriptions (quality confirms the code)
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Person decides
- Every disposition, per the authority table; root cause and actions; whether a customer or regulator must be told; CAPA closure
When it stops
What you end up with
- NCRs created in minutes, with suspect stock blocked and verified.
- Board decisions recorded with the approver's name and authority, not buried in notes.
- CAPAs that start with evidence and get chased until they close.
- One export per nonconformity and per CAPA, ready for your registrar.
Questions
Can AI write the root cause analysis?
The agent gathers evidence and can point out patterns. Root cause stays with the team that can walk to the machine.
Which defects should trigger a CAPA automatically?
You set it in a table: repeats within a window, any complaint, any critical characteristic. Start strict and loosen with data.
Does this work if our QMS is separate from the ERP?
Yes. The NCR can live in the QMS while stock moves run in the ERP. The agent keeps one record across both.
Does the new ISO 9001 edition change anything?
The tables and review steps change for your transition audit. The workflow does not need rebuilding.
No prompts. No babysitting. No Integrations.