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ISO 9001:2015 · AI ROOT-CAUSE ANALYSIS

Any tool writes the report. AuditInk gets the root cause right.

It turns on-site findings into a complete ISO 9001 report — then runs a live, senior-auditor interview that pushes past “operator error” to a defensible, systemic cause. And it tracks every corrective action to closure.

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AI ROOT-CAUSE INTERVIEW · NCR-001

Batch records not signed off for 3 production runs

5-Why

Your note says the operator forgot to sign the batch records. That's a symptom — let's find the system that should have caught it.

When a run finishes with records still open, does anything flag it before the product is released?

TRACING TO A SYSTEMIC CAUSE

As each link is confirmed, it builds here.

You’d have written “operator forgot to sign records.” AuditInk interviews you to the system gap behind it — live, grounded in your evidence.

A surveillance auditor rarely challenges your wording. They challenge your root cause.“Operator error” gets findings reopened — AuditInk gets you to a cause that holds up.

THE HERO · ROOT-CAUSE ENGINE

A senior lead auditor, sitting beside you.

Generic AI writes a tidy “5-Why” that still lands on the operator. AuditInk runs a real interview — one sharp question at a time, grounded in your evidence — until you reach a cause a certification body will accept. Then it carries that cause into the report.

Picks the method

5-Why, Fishbone (6M) or a guided interview — chosen to fit the finding, not forced.

Adequate vs. adhered

Attach the SOP and it judges whether the procedure is deficient or simply wasn't followed — and aims the CAPA accordingly.

Pushes past the symptom

It refuses to stop at “human error” and reframes toward the system that allowed it.

Sharpens the corrective action

When it converges, it rewrites the corrective action to eliminate the confirmed cause — and flags the confidence.

Fishbone5-WhySAME CAUSE · TWO READS
EFFECTRecords openPeopleProcessNo fallback routineMeasurementEquipmentMaterialsEnvironment

Confirmed root cause: the procedure has no record-control fallback for MES downtime, so product is released with batch records open.

01

From the floor to a closed-out finding.

STEP 01

Capture on site

Walk the floor and capture findings by voice, photo or tap — checklist, look-ahead or free-roam.

STEP 02

Generate the draft

A full ISO 9001 report: objective evidence, the right clause, severity, correction and corrective action.

STEP 03

Interview to the cause

Run the live root-cause interview to reach a defensible, systemic cause — the part that gets scrutinised.

STEP 04

Close the loop

Assign owners, collect evidence through a secure link, validate, and track every CAPA to closure.

02

Built the way an auditor thinks — not a generic chatbot.

Capture by voice on site

Speak a finding while you walk; AuditInk cleans it into a precise nonconformity statement — your words, no invented facts.

Live root-cause interview

A senior-auditor interview that picks its method, grounds each question in your evidence, and pushes past 'human error' to a real cause.

Grounded in real ISO 9001

Clauses come from an authoritative reference, never a guess — a wrong clause destroys credibility, so it won't invent one.

Track every CAPA to closure

Assign owners, collect their evidence through a secure link, validate, and close — the whole programme tracked, not just the report.

Export anywhere

A clean Word report, an Excel CAPA tracker, or a full closure pack (report + evidence) zipped for the visiting auditor — one click each.

Private by design

Your findings are processed only to draft your report. They are never used to train any model. You review and approve everything.

03

Don’t just write it. Close it.

Most tools stop at the document. AuditInk follows every non-conformance to closure — with action owners, evidence, validation, and a live tracker across your whole audit programme.

1

Assign the action owner

Pick from your team or type any email — they get a private link, no account needed.

2

They respond with evidence

Upload files, describe the corrective action, submit.

3

You validate & close

Review the evidence, then close it out — or send it back.

4

The tracker stays current

Open, in-progress, overdue and closed, across every audit.

Closure board

82% closed
NCR-011Northgate · Mixing2d late
NCR-002Harbour · CalibrationIn review
NCR-004Northgate · Supplier evalClosed
Ask AuditinkSOLO & TEAM

How should I approach the GMP maintenance audit at NJPPC?

Your audit is scheduled for 2026-06-30 — 42 checks across 5 areas. Start with the highest-risk areas:
  • Calibration — confirm the register has no overdue devices in service
  • Planned maintenance — PM schedule vs. actual, with justified deferrals
  • Pest control — verify devices are unobstructed and effective

Grounded in your own audits & reports · every answer cited

ASK AUDITINK

Chat with your whole audit programme.

Ask in plain language across every audit, finding and corrective action — and get a grounded plan for how to approach an audit you have only just planned. It sees your reports and your audits, and cites the records behind every answer.

  • Which findings are overdue right now, and who owns them?
  • What systemic themes show up across my audits?
  • How should I approach my next planned audit?
04

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  • Live AI root-cause interview
  • Word export
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  • Unlimited reports & audits
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  • Photos & SOP adequacy analysis
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Team

$99 / month

Run closure across your whole quality team.

  • Everything in Solo
  • Invite your team
  • Share specific reports & audits
  • Assign owners & validate together
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Stop defending “operator error.”

Write the report in minutes — and walk in with a root cause that holds up.

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ISO 9001:2015 · Your data is never used to train any model