Quality & Traceability

Inspections, AQL and COA

Items with a quality policy require inspection before release. AQL sampling (ANSI/ASQ Z1.4) computes the sample size and accept/reject numbers; passing inspections can generate a Certificate of Analysis with a public verification link. Retain samples are stored and swept per grade retention rules.

SPC control charts

SPC tracks X-bar/R charts per control-plan characteristic with ASTM control limits, three violation rules (beyond limits, range beyond limits, run-of-8) and live Cpk. Record subgroups from the page or the shop floor; violations broadcast instantly and raise Momentum work items.

Gauge R&R (MSA)

The Gauge R&R tab runs measurement-system studies with both AIAG methods:

• Average-and-range — EV, AV, GRR, PV, TV and %GRR.
• ANOVA (two-way with interaction) — variance components incl. operator×part interaction, %GRR and ndc (number of distinct categories).

Verdicts follow AIAG thresholds: <10% acceptable, ≤30% marginal, >30% unacceptable.

NCMR, CAPA and recalls

Non-conforming material reports hold stock; CAPAs run the corrective loop (with Momentum approvals). Recalls compute the full blast radius from lot genealogy — every downstream lot, order and customer touched by a suspect input.

Lot genealogy and compliance

Every material issue and output receipt writes the genealogy graph, so forward and backward traces are one click. Compliance packs (21 CFR 11 e-signatures, FSMA 204 KDE/CTE, EPCIS events, HACCP CCPs, UDI) activate per industry preset, and the audit hash chain is verifiable via php artisan mfg:audit-verify.