Non-Conformance & CAPA Agent
Refuses to accept operator error as a root cause
- 8hard rules
- Things it must never do, enforced in every run
- 5handover rules
- Conditions where it stops and gives the work to a person
- 10output fields
- A structured result, not a paragraph you have to re-read
- ≤6steps per run
- Bounded work: at most 5 tool calls, enforced by the runtime
Read-only by design. This agent has no path to sending, spending, publishing or committing anything. Where that limit is the product, removing it would remove the reason to trust the output.
Overview
A large share of corrective action reports name "operator error" or "training" as the root cause. Auditors reject both, and rightly: they say who, not why. The corrective action becomes retraining, nothing changes, and the same non-conformance recurs six months later — which is the finding that actually threatens a certification.
This agent works from your defect record and your own quality procedure. It builds the sequence of what happened, asks why each condition was possible rather than who allowed it, and refuses to accept a cause that a person's behaviour alone explains — if one operator could cause this, the process permitted it, and that is the finding.
Every corrective action it proposes has a verification method, because an action nobody checked is not a corrective action. It also flags where the same cause appears in earlier records you supply, since a recurrence is a different and more serious finding than a first occurrence.
Benefits
Reports that survive an audit
Causes stated as conditions, actions stated as verifiable.
Hours per CAPA, back
The structure and the drafting, done.
Recurrences visible
The pattern across records, which no single report shows.
What it does
Rejects a person as a cause
If one operator could cause this, the process allowed it. That is the finding, and auditors agree.
Follows your quality procedure
Reads your own documented process from your knowledge base, not a generic standard.
Every action gets a verification
An action nobody checked afterwards is not a corrective action, and it fails the next audit.
Separates containment from correction
Sorting today's batch is containment. It does not stop the next one, and reports must not conflate them.
Flags recurrence
The same cause appearing in an earlier record is a more serious finding than a first occurrence.
Marks what is unknown
An unestablished cause is reported as unestablished, with what to check.
What this changes
What this changes about your week
- It takes over
- Writing corrective action reports that survive an audit.
- Done today by
- A quality engineer with eleven open CAPAs.
- How often
- Every non-conformance.
- Typical manual effort
- A properly investigated CAPA is half a day.
Why Manufacturing in particular. It refuses operator error as a root cause. That answer gets rejected, produces retraining that changes nothing, and the defect returns in six months.
Runs unattended
Started by you or by an event, and it finishes on its own. Nothing waits for someone to be at a desk.
The same standard every time
The two-hundredth item is held to the bar the first one was. Consistency is the part people cannot sustain.
It cannot act on its own
Non-Conformance & CAPA Agent has no path to sending, spending or committing. That limit is why its output is safe to act on.
How it runs
This agent runs server-side through the PROMIVO runtime. Each run is logged step by step and every tool call is permission-checked before it executes.
- 1InputValidated against the agent input schema
- 2Modelclaude-opus-5 with automatic fallback
- 3Toolssearch_knowledge, extract_structured_data
- 4PermissionsRuns READ actions automatically; anything higher waits for approval
- 5OutputStructured result matching the output schema
- 6LoggingTokens, duration and every step recorded
Demo
Demo dataIllustrative sample output, abridged.
Input
{
"record": "…",
"product": "Housing assembly",
"reference": "NCR-2291"
}Output
{
"causes": [
{
"why": "—",
"status": "not-a-root-cause",
"condition": "Operator fitted the wrong seal variant.",
"processQuestion": "Both seal variants are stocked in adjacent bins with near-identical part numbers and no poka-yoke at the station. Why is fitting the wrong one physically possible?"
},
{
"why": "The work instruction names the part but the station has no verification step.",
"status": "root-cause",
"condition": "No physical or system check prevents the wrong seal being fitted.",
"processQuestion": ""
}
],
"escalate": false,
"disclaimer": "A drafted CAPA for review by a qualified quality engineer. No disposition decision has been made and no conformity conclusion is stated.",
"containment": [
"Quarantine and inspect the affected batch — does not prevent recurrence."
],
"procedureFound": true,
"correctiveActions": [
{
"action": "Separate the two seal variants and add a verification step at the station.",
"addressesCause": "No check prevents the wrong seal being fitted.",
"verificationMethod": "Deliberate wrong-part attempt during a controlled trial; the station must reject it. Re-check after 30 days of production."
}
]
}Requirements
Integrations
No integrations required.
Before you start
- The defect or non-conformance record
- A knowledge base holding your quality procedures
- Requires the All-Access plan or higher
Use cases
A new non-conformance
Record to draft CAPA in one pass.
Before a certification audit
Find the reports that will be rejected.
Customer complaint
A response built on a cause rather than an apology.
Pricing
All-Access
Billed monthly through your PROMIVO subscription. Cancel at any time.
Runs consume your plan allowance for agent executions and tokens. See plan limits
FAQ
Why will it not blame the operator?
Because auditors do not accept it and it does not prevent recurrence. If a single person's mistake can produce a defect, the process has no barrier — and that missing barrier is the corrective action.
Does it decide whether to release a batch?
No. Disposition is a quality decision with product safety and regulatory consequences, and it stays with a qualified person.
What if we have no documented procedure?
It says so and works from the defect record alone, marking that the procedural check was not performed. It will not substitute a generic standard for yours.
Reviews
Reviews open once customers have run this agent.
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