Operated under SLA
Not a one‑off consulting project. We tune, retrain and run the agents we build — quarterly reviews included.
QMS automation as a service Quality AI Agents & QMS Consulting
We design, deploy, and operate AI agents that automate quality workflows — CAPA, PPAP, SPC, audit prep, traceability — integrated with your existing QMS. Delivered as a service, scoped to ISO 9001, ISO 3834, IATF 16949, EN 1090 and AS9100.
- Custom AI quality agents trained on your standards, procedures, and historical defects
- QMS gap analysis and remediation plan aligned to ISO 9001, ISO 3834, IATF 16949, EN 1090, AS9100
- Audit‑ready evidence pipelines (CAPA, PPAP, SPC, NCR) with full digital traceability
- SLAOperated by us, owned by you
- 9+Standards covered
- QuarterlyKPI & retraining cycle
- 0Rip‑and‑replace
What we deliver
Therness builds and runs AI quality agents tailored to your operation — not a packaged product, a consulting and delivery service. We map your standards, train models on your data, and integrate with your existing QMS, MES and ERP. You keep ownership of the workflows; we maintain and tune them under SLA.
- Quality AI agents — task‑specific assistants that draft NCRs, route CAPAs, summarise audit findings, build PPAP packs and surface SPC out‑of‑control signals from your weld and process data.
- QMS design and remediation — gap analysis against the standards your customers require, with a prioritised remediation roadmap and document migration support.
- Standards mapping — ISO 9001, ISO 3834, ISO 5817, IATF 16949, EN 1090, AS9100, IEC 62443 (OT security overlay where relevant).
- Integration with your stack — the AI agents read and write into your existing QMS, MES, ERP, DMS and CAQ systems. No rip‑and‑replace.
- Operations under SLA — tuning, retraining and incident response handled by Therness; you focus on quality decisions, not model maintenance.
Method
- Discovery — quality processes mapped, standards inventory taken, pain points and audit findings collected from the last 24 months.
- Gap analysis — current state versus target standards (ISO 9001, ISO 3834, IATF 16949, EN 1090 as applicable). Output: ranked remediation backlog.
- Agent design — for each quality task we automate, define inputs, outputs, escalation rules and human‑in‑the‑loop checkpoints. No black boxes.
- Pilot — one or two agents deployed against historical data, then live shadow mode, then production with override authority retained by your quality team.
- Rollout and SLA — staged rollout with retraining cadence, KPI tracking and quarterly review. Therness handles model maintenance under SLA.
Typical agents
- **NCR drafting agent** — turns weld monitoring alarms (Therness HeatCore or third‑party) into draft non‑conformance reports with root‑cause hypothesis, classification and required actions.
- **CAPA routing agent** — triages incoming CAPAs, assigns owners based on competence matrix, suggests due dates and escalates ageing items.
- **PPAP / FAI assembly agent** — collects evidence from MES, QMS and weld traceability records, assembles PPAP packs (Levels 1–5) and First Article Inspection reports.
- **SPC anomaly agent** — watches production data, flags out‑of‑control signals per Western Electric / Nelson rules and produces a daily quality digest.
- **Audit prep agent** — given an audit scope (ISO 3834‑2, IATF 16949, EN 1090 EXC2/3/4), produces evidence index, gap report and witness preparation notes.
- **Document compliance agent** — checks WPS, PQR and work instructions for revision currency, signature completeness and standards alignment.
Deliverables
- QMS gap analysis report with remediation backlog (effort, impact, owner)
- Custom AI quality agents — deployed, integrated, and tuned on your data
- Standard operating procedures (SOPs) covering human‑in‑the‑loop checkpoints
- Audit‑ready evidence pipeline (CAPA, PPAP, SPC, NCR) with full digital traceability
- Quarterly KPI report (defect escape rate, audit findings, agent precision/recall)
- Knowledge transfer and training so your quality team owns the workflow
Standards we work with
- ISO 9001
- ISO 3834 (1–5)
- ISO 5817
- IATF 16949
- EN 1090 (EXC1–4)
- AS9100
- EN 15085
- ISO 17635 / 17637
- IEC 62443
Audience
Who this is for
We help quality and operations leaders move from manual QMS work to auditable, AI‑assisted automation.
- Quality managers under audit pressure (IATF surveillance, ISO 3834 renewal, EN 1090 EXC3/4 transition)
- Plant managers with rising customer‑side rejections and no time to manually re‑engineer the QMS
- Operations leaders pushing for digital traceability without ripping out the existing CAQ / MES
- OEM supplier quality teams managing multi‑site, multi‑standard programmes
Frequently asked questions
Is this a software product or a service?
A service. We build, integrate, operate and tune the agents under SLA. You don't buy a licence — you buy the outcome.
Do you replace our existing QMS?
No. The agents read and write into your existing QMS, MES, ERP, DMS and CAQ systems. No rip‑and‑replace.
Who owns the models and the data?
You. Models trained on your data stay yours. We provide harness, integrations and operations.
How long until we see value?
First agent typically pilots in 4–6 weeks against historical data, then runs in shadow mode, then production with quality team override.
Which standards do you cover?
ISO 9001, ISO 3834 parts 1–5, ISO 5817, IATF 16949, EN 1090 EXC1–4, AS9100, EN 15085, ISO 17635/17637 and IEC 62443 where OT security applies.
Difference
Why Therness
Domain‑specific
Welding and metals manufacturing is our core. ISO 3834, EN 1090, ISO 5817 are languages we speak fluently.
Standards‑first, not LLM‑first
Agents are scoped to specific tasks with auditable inputs and outputs. No autonomous decisions on quality acceptance.
Your data, your models
Models trained on your data stay yours. We provide the harness, the integration and the operations.
Turn quality from a backlog into a system
Send your standards scope, current QMS stack, and the audit horizon. We send back a gap snapshot and a 30‑day pilot proposal within two business days.
