Alpha Pumps QMS v0.4

— critical findings need action. Open NCRs: — · Open complaints: — · Required training current: —%.

Sample data from the ISO QMS Studio v0.4 demo (fictional company), assessed 11 Oct 2026 by the app's rule engine (64 rules). Findings are rule-based flags, not compliance conclusions.

Critical findings—Stop-and-fix issues
Major findings—— minor
Open NCRs—of — raised
Open complaints—of — logged
Training current—%— of — required
Lots on hold—of — lots tracked

Findings by area

Open findings from the latest assessment, by severity.

Special process validation

IQ/OQ/PQ status and production runs checked against the validated window.

Findings

Each finding names the rule that raised it and the ISO 9001 clause topic.

Finding Detail

Digital records

Nonconformance reports

Raising an NCR holds the lot; an independent MRB member signs the disposition.

NCRLotSourceDescriptionDispositionStatus

Customer complaints

Age in days for open complaints; days to close for closed ones.

RefCustomerLotSeverityStatusDaysCAPA

Training matrix

Required training per person, by position. Expiring means within 30 days.

CurrentExpiringExpiredMissing

Read and understood

Acknowledgements of the latest approved document revisions.

PersonDocumentRevDueStatus

Suppliers

Supplier scorecards

Last 365 days. Score weights: quality 50%, delivery 30%, responsiveness 10%, compliance 10%.

Supplier Grade Score Reject ppm On time Recommended Decided

Monthly incoming reject rate

Parts per million rejected at goods receipt. Each supplier is on its own scale.

Lots and requirements

Lots by status

Quarantined and rejected lots cannot ship.

Requirements

Inspection results and evidence rating per requirement.

RefRequirementPassFailVerificationRating

Lots

Raw material, work in progress and finished lots.

LotTypeItemDateShipmentsStatus