Coating thickness reading out of spec on line 2.
PRT-4412 housing · WO-8817 · caught at in-process check
Quality Management System
A finding isn’t closeduntil the fix is proven.
Non-conformance, CAPA, Audit, and Supplier Quality on one governed record, so every finding carries an owner, an action, and a verified close.
One governed quality record across regulated operations
- Medical Devices
- Pharmaceuticals
- Automotive
- Aerospace
Most systems close a CAPA when the paperwork is signed.
Unifize closes it when the effectiveness check passes, traced back to the event that raised it.
- Finding ownership
The finding stalls at owner assignment
Nobody owns the finding, so no clock runs on it.Named owner and due date. Every finding converts to an owned action on a clock.
How they handled it · 2:38Biovation Labs - CAPA effectiveness
The CAPA closes before the fix is proven
Weeks of slip past the verification target.Effectiveness verified on a date. Verified in a set window. Reopens if ineffective.
How they handled it · 2:54Applechem - Supplier quality
The SCAR closes, the supplier doesn't change
Repeat failures of the same defect, delivery after delivery.Closure on verified change. The SCAR stays open until the change is verified.
How they handled it · 3:23Harmonic Bionics - Audit evidence
Passing the audit costs days of rebuild
Days of team time to assemble evidence, per audit.Evidence already bound. Disposition evidence bound as the work happens.
How they handled it · 1:33Harmonic Bionics
The quality system, bundled.
Six disciplines on one governed deployment, so an event that starts on the floor ends in a defensible, closed record.
Non-conformance
Every event starts accountable.
Capture, disposition, and closure of non-conformances with required fields, named ownership, and evidence binding. Escalates into CAPA when it is warranted.
- Required intake fields
- Named owner and due date
- Disposition evidence bound in
- Escalation into CAPA
ISO 9001ISO 1348521 CFR 820
Corrective & Preventive Actions
Nothing closes unproven.
Root-cause acceptance, action plan, effectiveness verification, and closure, with the relation back to the event that raised it.
- Approved root-cause method
- Owned action plan
- Effectiveness window
- Automatic reopen if ineffective
ISO 9001ISO 13485ICH Q10
Complaint Handling
One trace from intake to close.
Intake, triage, investigation, and closure of customer complaints, with regulatory reportability assessed on the record.
- Structured complaint intake
- Triage and investigation
- Reportability assessment
- Evidence-backed closure
ISO 1348521 CFR 820MDSAP
Audit Management
Every finding stays on the record.
Scheduling, finding tracking, response routing, and effectiveness verification across internal, external, and customer audits.
- Audit scheduling
- Finding ownership
- Response routing
- Effectiveness verification
ISO 9001AS 9100MDSAP
Supplier Quality
Supplier signals become action.
SCAR lifecycle, supplier qualification, incoming-inspection alignment, and scorecard maintenance on one supplier record.
- SCAR lifecycle
- Supplier qualification
- Incoming-inspection alignment
- Composite scorecards
IATF 16949AS 9100ISO 13485
Quality Risk Management
Risk controls stay current.
Risk register, assessment workflows, control verification, and periodic review, aligned to ISO 14971 and ICH Q9.
- Governed risk register
- Assessment workflows
- Control verification
- Periodic review
ISO 14971ICH Q9ISO 13485
The controls a quality system runs on.
Root-cause governance
The RCA method is named and approved by the QA Manager before a CAPA can leave investigation.
Effectiveness verification
A CAPA closes only after its effectiveness check passes inside the assigned window: 30, 90, or 180 days by severity.
Evidence binding
Every event, action item, and audit finding carries the evidence that makes it defensible under audit.
Reopen governance
An ineffective outcome reopens the record to investigation automatically, instead of quietly ending it.
Bounded auditor access
Internal, external, and customer audits run with scoped participation, not the run of the whole system.
SCAR to scorecard
A supplier corrective action feeds the supplier's composite scorecard and approved-supplier tier.
Every quality event has an owner, an action, and a proven close.
Follow the work through the lifecycle.
Works with the systems you already run.
Connect the quality record to the tools already holding your lots, suppliers, and complaints.
- SAP
- Oracle NetSuite
- Microsoft Dynamics 365
- Salesforce
- Jira
- Slack
Built for the people a quality finding lands on first.
From the first signal on the floor to the effectiveness check, every role works from the same quality record.
Training Coordinator
OwnsCorrective actionRetrained
- Assign retraining when procedures change
- Chase incomplete training to closure
- Produce training evidence for audits
Engineering Manager
OwnsCAPADesign
- Sign off CAPAs and deviations affecting engineering
- Chair design reviews, review FMEAs
- Report engineering quality to management review
Production Supervisor
OwnsSignalContainment
- Investigate deviations at the point of use
- Coordinate with quality on holds and releases
- Close handovers between shifts
Quality Inspector
OwnsIntakeDisposition
- Perform inspections to plan, sample against AQL
- Raise non-conformances, segregate failing material
- Release passing material, escalate the rest
EHS Manager
OwnsIncidentClosed action
- Triage incidents and near misses
- Assign and track corrective actions
- Close out audit findings
Lab Manager
OwnsOOS resultRelease
- Review OOS investigations
- Release results, approve methods
- Sign off stability programs
Continuous Improvement Lead
OwnsRoot causeEffectiveness
- Run 8Ds on recurring findings
- Track benefits against the effectiveness window
- Report progress to the steering committee
APQP Engineer
OwnsControl planPPAP
- Build control plans, lead PFMEAs
- Chair phase gate reviews
- Coordinate PPAP and supplier sub-PPAPs
OwnsDispositionClosure
- Approve higher-risk dispositions and CAPA closures
- Lead internal and ISO audits
- Chair management review
What quality teams say when the proof stays on the record.
Short, candid accounts of non-conformances, CAPAs, audits, and supplier quality from the people who run them.
The Will-Burt CompanyTedd Carr, Director of Quality ControlInternal NC closure down from 4 to 5 weeks to 7.2 days
Harmonic BionicsClarissa ArcherNCs, deviations and CAPAs linked to part, lot and supplier
ApplechemWilson LinEach corrective action step has an owner and a due date
Harmonic BionicsDenis MachokaAudit prep without trawling through thousands of emails
Biovation LabsJesse Kolstad, Director of QualitySupplier scorecards that show the bad actors and the good
Biovation LabsJesse Kolstad, Director of QualityA mock recall done in 18 minutes against a 4-hour window
One governed quality system, whatever you are audited against.
Control the quality record once, then prove it against whatever governs your operation.
- ISOISO · Global
ISO 9001
Quality management system requirements.
- ISOISO · Global
ISO 13485
QMS for medical devices.
- FDAFDA · US
21 CFR 820
Quality System Regulation for device cGMP.
- IATFIATF · Global
IATF 16949
QMS for automotive production.
- IAQGIAQG · Global
AS 9100
QMS for aviation, space, and defense.
- ECEC · EU
EU GMP
GMP for medicinal products (EudraLex Vol. 4).
- ICHICH · Global
ICH Q10
Pharmaceutical quality system across the lifecycle.
- IMDRFIMDRF · Global
MDSAP
One device audit across US, Canada, Australia, Brazil, and Japan.
Validated across
- Medical Devices
- Pharmaceuticals
- Automotive
- Aerospace
The questions quality and procurement ask first.
Anything else, bring it to the walkthrough.
Six modules on one governed record: Non-conformance, Corrective and Preventive Actions, Complaint Handling, Audit Management, Supplier Quality, and Quality Risk Management. An event that starts as a non-conformance escalates into a CAPA without re-entry.
Close the finding. Keep the proof.
Bring the finding that has been open too long and watch it run from the event to root cause to a verified, effectiveness-checked close in a 30-minute walkthrough.