ManufacturingLegal & Compliance
Non-conformance. Documented, not deferred.
Generates corrective and preventive action (CAPA) documentation from a non-conformance finding — root cause, corrective steps, and preventive measures, cited to the specific standard clause. Built for quality teams closing dozens of CAPAs a quarter.
13 cited fields per CAPA. Built on Sphere AI Foundry.
capa_report — finding #NC-51092LIVE
00:00Ingest → non-conformance finding, lot #4471, dimensional defectread
00:03Root cause → tooling wear identified from inspection logpassed
00:05Standard check → ISO 9001:2015 §10.2 CAPA requirementpassed
00:07Verification → corrective action effectiveness not yet confirmedflagged
00:08Disposition → Route to quality manager, verification pendingrouted
draft time 5 minfields cited 13/13QM sign-off required
Built on Sphere AI Foundry·Cited to standard & root cause·21 years, 300+ clients
Manual CAPA drafting doesn't scale with finding volume
A single CAPA report means a quality engineer investigating root cause, writing up corrective and preventive steps, and citing the specific standard requirement — usually from a template that's been copy-pasted and drifted from what the standard actually says. At low volume that's manageable. Across dozens of non-conformances a quarter, it's the reason CAPA backlogs build up and an auditor finds inconsistent documentation.
76%
faster first-draft CAPA vs. manual writeup
13
fields extracted & cited per CAPA
100%
of corrective actions traceable to the standard clause and root cause
Finding in, cited CAPA out
Four steps, every one logged and citable back to the standard and the data.
01
Ingest
Reads the non-conformance finding directly from your systems
Non-conformance report, inspection log, and prior CAPA history on the same issue — read from your QMS. No separate upload step.
Source document
NC-51092 — lot #4471, dimensional defect
02
Analyze root cause
Root cause matched against inspection data
Inspection logs, tooling records, and process data — analyzed to identify the likely root cause, not assumed from the defect type alone.
Example query
"What does the inspection log show about tooling condition on this lot?"
03
Cite every action
No corrective action without a citation
Each corrective and preventive action links back to the exact standard clause and inspection record — the citation travels with the finding, not as a separate lookup.
Cited finding
Root cause: tooling wear beyond tolerance, confirmed in inspection log IL-4471 — corrective action requires tooling replacement and verification.
cited to ISO 9001:2015 §10.2, Inspection Log IL-447104
Classify & route
One disposition, one drafted CAPA report
The agent returns CAPA Complete, Verification Pending, or Needs Further Investigation, with the drafted report routed to the quality manager for sign-off.
Disposition
CAPA completeVerification pending ✓Needs further investigation
10 fields, every one cited
What the agent extracts into every CAPA report.
CAPA summary & disposition
Non-conformance description & lot reference
Root-cause analysis
Corrective action plan
Preventive action plan
Standard clause citation (ISO/AS9100/etc.)
Effectiveness verification status
Prior CAPA history on this issue
Consolidated CAPA report draft
Quality manager review checklist
Typical inputs
What the agent reads, and what it connects to.
Documents
- Non-conformance report
- Inspection logs and process data
- Applicable quality standard (ISO 9001, AS9100, etc.)
- Prior CAPA history
Systems
- Quality management system (QMS)
- Manufacturing execution system (MES), where applicable
- Document repository
Is this the right fit?
Built for a live QMS — not a one-off finding.
✓ Works best for
- Manufacturers closing 10+ CAPAs a quarter
- Teams standardizing CAPA documentation against a fixed standard
- Quality wanting every corrective action traceable to root cause and standard
Too small for
- A single CAPA a quality engineer can draft faster than configuring the match
- Replacing quality engineer judgment on root cause or corrective action selection
- Standards or processes with no documented requirement to cite
Grounded in the standard and the data, not a black box
Compliance-first, the same standard every Sphere agent is held to.
The agent requires the non-conformance report and inspection data before it will draft a CAPA, and every draft sits between finding and quality manager sign-off — never past it. A quality manager confirms every CAPA before it closes.
Corrective actions reference the specific standard clause and inspection data directly — the same audit-trail standard every Sphere agent on the Foundry is held to.
Prerequisites finding + inspection data
The non-conformance report and inspection data are required before a CAPA is drafted.
Human review required
A quality manager confirms every CAPA before it closes — never fully autonomous.
Source grounding standard-cited
Corrective actions reference the specific standard clause and inspection data directly in every report.
Foundation Sphere AI Foundry
Access controls and audit trail configured here carry forward to every other agent you deploy.
Frequently asked
Does the CAPA & Quality Documentation Agent replace a quality engineer?
No. It drafts the CAPA and cites the root cause and standard requirement — a quality manager still confirms every CAPA before it closes.
What standards does it support?
ISO 9001 out of the box. AS9100, IATF 16949, and other standards can be added during onboarding.
How does it integrate with our QMS?
It reads directly from your quality management system or MES — no separate upload step required. Integration scope is confirmed during deployment planning.
Is every corrective action traceable to real data?
Yes. Every corrective action cites the specific standard clause and inspection record it came from — there is no action without a citation back to the source.
How is this different from a generic CAPA template?
It's built to analyze your actual inspection data and cite the specific standard clause, not fill in a static template. It runs on Sphere AI Foundry, so the access controls and audit trail configured here carry forward to other agents you deploy.
Start here
See it on your own non-conformance findings
Bring a real non-conformance finding to the demo. We'll show the CAPA draft live — root cause, citations, and the corrective action plan, on your own data.
Looking for a different workflow? Browse the full Agent Catalog.
Talk to a solutions architect
Direct to a senior architect — never a sales queue. Replies within one business day.
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