Quality Management System (QMS)

Quality Management System (QMS). QMS is quality management: inspection evidence, NCR, CAPA, holds, and dispositions tied to product and lot identity. Quality is a record on the product — not a binder on a shelf.

In industry this is ETQ / MasterControl / TrackWise-class QMS capability. In N23D it is not a seat next to someone else’s stack. It is a peer module on one native Rust binary — N23D — 100% Rust we write.

Cylindrical CMM — inspection on the product identity

Same product. The inspected identity is the CAD and CAM identity. NCR is per LegalEntityId. A failed check is not a screenshot in an email. Disposition is a decision on that record. CCB may authorize process or product change that follows a CAPA — without becoming a second quality vault.

What QMS actually does

  • Document control: draft, review, released, obsolete. Training required on a new revision. A released SOP cannot be edited in place. The new revision trains the cell.
  • Training and competence matrix: person, document and revision or skill, date, expiry. Person identity comes from BUS. BUS does not own SOP control.
  • Nonconformance, NCMR, and material review board. Disposition: use-as-is, rework, scrap, return. An NCR lives on the entity that owns the serial or lot. Group SOP templates may be shared documents. MES out of spec opens the NCR, holds the unit, and ERP cannot ship.
  • CAPA, 8D and ISO 13485-capable: problem, root cause, corrections, actions, effectiveness check. The effectiveness task blocks close until it is done.
  • Complaints and vigilance (medical pack). A CRM case may originate a complaint.
  • Audits: internal, supplier, registrar. Calibration and MSA. Supplier quality: incoming, score, SCAR. Material cert attaches through Materials pedigree on the lot.
  • Risk: FMEA and ISO 14971 file. Product FMEA stays here. Project risks stay in PMO.
  • eDHR, DMR, and DHF links (medical pack). Payload from MES and PLM. Signature here.
  • 21 CFR Part 11: unique user, e-sign meaning, immutable audit trail. Audit trail is append-only. No update-in-place of a signed record. Signed record replay matches the trail.
  • Change participation on the PLM engineering change order as quality approver. Use-as-is on a released product is a deviation that PLM must see.
  • Lot hold to ERP blocks pick and ship on an open critical NCR. Simulation verification evidence links to a requirement.
  • Industry packs: ISO 9001 default. ISO 13485, AS9100, and IATF 16949 as content. 100% Rust we write. No MasterControl or ETQ runtime.
Bridge-type CMM in metrology — QIF and disposition on the record

How N23D puts this in one place

Most stacks fail the day after save, when the model, the ticket, or the invoice becomes someone else’s import. N23D removes that day. This module reads the same record as the others.

  • one native Rust binary: N23D. 100% Rust we write. No vendor kernel, ledger, PLC runtime, HRIS, or ITSM as the source of truth. File readers and protocol bridges are interchange.
  • One identity plane: Item, VariantId, Person, and AssetId are global. Invoice, work order, inventory, quote, pay result, and NCR sit on a LegalEntityId.
  • One digital thread: modules read the same record. There is no daily STEP shuffle as the workflow. Check-in is PLM save. CAM does not fork the body.
  • Command::Core is the identity and policy plane. CCB is the full-spectrum change spine (not a second vault). TIX holds operational life of assets; ERP sees only the financial view.
  • Materials only from MAT. CAD selects VariantId. Missing density means mass is unknown — we do not invent a number so a BOM or plot closes.
  • ERP is one company’s books. BUS holds HR, org, legal entities, and group consolidation. HoldCo is not a plant. No fake Form 1120. No fake Lohnsteuer.
  • Inspection programs are CAM work product on the same body. CMM AssetId lives in TIX.
  • Open critical NCR blocks ERP ship. MES captured the fail; QMS dispositions it.
  • PLM holds effectivity of the spec that was failed. CCB records the authorized change.
Rockwell hardness tester — QC lab evidence for CAPA and NCR

What we will not fake

This is the product promise, not a claim that every solver and every pack already ships in the binary today. Industry-class names below are capability equals. They are not products we ship.

  • We do not ship a QMS island or a certificate mill.
  • An 8D in PowerPoint is not CAPA. A calibration log in a drawer is not metrology control.
  • File readers are interchange. Honesty about v1 scope is part of the contract.

If quality still cannot name the body, we failed. Design, make, and prove it on one auditable thread.

Natively connected, not glued together

N23D runs one data model across design, make, operate, and the business. Nothing is exported as the daily path. Nothing is re-keyed. Nothing is lost in translation between vendors.

  • One data model. A part, an order, a nonconformance, a ticket, and a change point at the same objects. No mapping tables, no nightly sync, no drift.
  • No export/import loss. Geometry, tolerances, revisions, asset state, and history stay intact because they never leave the system as the daily path.
  • Auditability by default. Every change is versioned and attributable, so traceability is a query, not a project.
  • Speed. 100% Rust: native performance, small footprint, no runtime surprises.
  • Sovereignty. Your data, your infrastructure, your rules. No lock-in.