From finding to closure,
with the root cause.
Audit findings, customer complaints and process nonconformities in one record; the CAPA/8D flow is tracked step by step from root cause to verification. Data from measurement devices is compared with the control plan, the defect Pareto builds itself. Processes aligned with ISO 9001 / IATF 16949; the certificate comes from the audit body.
One quality system from audit to measurement, CAPA to certificate
The quality team records the finding, the system classifies it and opens the CAPA; root cause and actions are tied to a person, a date and a verification rule. A traceable record instead of spreadsheets and e-mail.
Audit plan and finding records
Internal/external audit calendar, checklists, auditor assignment; every finding is recorded with its class (major/minor/observation), gets an owner and a due date, and turns into a CAPA.
"Internal audit 14 Oct · 3 findings · 2 CAPAs opened"CAPA / 8D flow
D1 team, D2 description, D3 containment, D4 root cause (5 Whys, fishbone), D5-D6 action and implementation, D7 prevention, D8 closure. Every step approved, dated and traceable.
"CAPA-0142 · D5 · 2 actions · due 28 Oct"Measurement integration and control plan
Incoming, in-process and final inspection values come from devices such as CMM, scales and calipers or from the operator form; they are compared with the control-plan tolerance and a nonconformity opens on deviation.
"Diameter 12.05 mm · out of tolerance · record opened"Scrap, waste and defect Pareto
Scrap and waste by defect code, line, shift and supplier; the Pareto highlights the top 3 causes and flags recurring nonconformities.
"Surface crack: 41% of scrap cost · 3rd month"Customer complaints and supplier nonconformities
Complaints from customers and nonconformities sent to suppliers share the same skeleton; an 8D response is requested through the supplier portal and scored for time and quality.
"SUP-087 · 8D response in 7 days · score 82"Document and certificate tracking
Quality manual, procedures and instructions are versioned; expiry dates of customer and supplier certificates are tracked. Process structure aligned with ISO 9001 / IATF 16949; the certificate itself is issued by the audit body.
"PR-07 v4 live · 2 certificates expire within 60 days"The CAPA journey of a customer complaint
A representative flow: from finding to 8D closure, which step the system does automatically and where the quality team decides. The same skeleton applies to internal-audit findings, supplier nonconformities and process deviations.
- Customer complaint recorded
An automotive customer reported surface cracks on 12 bushings; the quality engineer opened the complaint with photos and the lot number. The system matched the lot from the ERP: 2026-0917, 1,800 parts. - Classified, 8D opened
Customer complaint + safety-part rule: class "major", 8D mandatory. CAPA-2026-0142 opened; the team (D1) was proposed from the template: quality, production, heat-treatment lead. - Containment (D3) decision
The quality manager quarantined the 600 unshipped parts of the same lot and decided on 100% inspection of the stock at the customer. The decision was recorded with its reason. - Measurement data and Pareto prepared
Surface-defect records of the last 90 days, furnace temperature logs and shift data were gathered on one screen; the 3rd recurrence of the same defect code was flagged. - Root cause (D4) completed
The team filled the 5 Whys on the card: thermocouple drift → temperature 20 °C low → insufficient tempering. The fishbone attachment and the measurement chart were linked to the record. - Actions (D5-D7) assigned
Thermocouple replacement and weekly calibration (maintenance, 28 Oct), a temperature-verification step in the control plan (quality, 30 Oct), prevention for 2 similar furnaces (D7). Every action is an approved task in the Workflow engine. - Verification rule and customer report
Closure rule: 3 consecutive lots with zero surface defects, 30 days. An interim 8D report was prepared for the customer as PDF; it will be sent after the quality manager approves.
Every nonconformity is one record: finding, class, containment, root cause, actions, owners and verification together. Shown to the auditor on one screen.
12 parça · lot 2026-0917majorfırın termokupl sapmasıcompletedtermokupl değişimi · kalibrasyondue 28 Octbakım şefi · kalite müh.assigned3 lot · 30 günpendingCAPA card, audit calendar, defect Pareto dashboard
Sample screens: the 8D card for the quality engineer, the plan calendar for the audit team, the recurring-defect dashboard for management.
| Date | Audit | Scope | Findings |
|---|---|---|---|
| 14 Oct | İç | Talaşlı imalat | 3 |
| 21 Oct | Tedarikçi | TED-087 | — |
| 4 Nov | Müşteri | OEM · IATF | — |
| 18 Nov | Belgelendirme | ISO 9001 | — |
How does it work in your industry?
Pick your industry to see which audit templates and flows come ready and what is shaped by your control plan.
Your OEM customer's 8D, PPAP and control-plan expectations with ready templates; process structure aligned with IATF 16949.
Customer-complaint 8D flow, control plan and measurement integration, supplier scoring and customer-audit preparation come on day one; configured for your part families and line structure.
- Customer 8D and complaint responseMajor class triggers 8D automatically; interim and closure reports in OEM format.
- Control plan and SPCCritical characteristics from CMM and calipers; nonconformity on out-of-tolerance values.
- Supplier nonconformity and scoreIncoming inspection rejection → 8D request → response time and quality score.
- Customer and certification auditsChecklist, evidence documents and finding tracking on one screen.
Which line, which shift and which defect code the scrap comes from; visible with a Pareto.
Defect codes, scrap cost and process deviations are recorded on casting, machining and welding lines; recurring nonconformities become CAPAs, material certificates are tracked.
- Scrap and waste analysisCost by line, shift and defect code; top 3 causes in a weekly summary.
- Process deviation and CAPAHardness, dimension and surface deviations; root cause and permanent action.
- Material certificate trackingSteel and casting certificates per lot; alert on missing certificates.
- Welding and NDT recordsInspection results and personnel qualification dates.
Processes aligned with HACCP and BRC/IFS; CCP deviations recorded instantly, recall traceability.
Critical control point measurements (temperature, pH, metal detector) come from scales and sensors; a deviation opens a nonconformity, customer complaints and supplier raw-material nonconformities are tracked in the same flow.
- CCP monitoring and deviationTemperature and pH readings compared with limits; CAPA on deviation.
- Customer complaints and recallComplaint → lot → shipment trace; mock-recall record.
- Supplier raw-material nonconformityIncoming inspection rejection, supplier 8D response and score.
- Hygiene and internal auditsDaily/weekly hygiene audits from mobile; findings and actions.
Deviation, OOS and change control in a GMP-aligned flow; every record signed and immutable.
Deviation, out-of-specification (OOS) and change-control flows; lab measurements are shared with the LIMS, document versions and training records are audit-ready.
- Deviation and OOS flowRecord → impact assessment → root cause → CAPA; QA approval.
- Change controlProcess, equipment and document changes in an approved flow.
- Documents and training recordsSOP versions; a training task for affected staff on each new version.
- Supplier qualificationAudit, certificates and performance score on one card.
Processes aligned with ISO 13485; complaints, CAPA and design changes in one traceability chain.
Customer/user complaints, adverse-event assessment, CAPA and design-change records are linked per product and lot; technical-file documents are kept versioned.
- Complaints and adverse eventsRecord, risk assessment, reporting decision; CAPA link.
- CAPA and effectiveness checkRoot cause, action, effectiveness verification; QA closure approval.
- Design and production changesChange control; affected documents and training.
- Supplier and sterilization recordsCritical supplier audits, batch records and certificates.
Live in four steps, in-house
- 01
Discovery
We map your current CAPA, audit and measurement practice together: defect codes, classification rules, control plans, customer format expectations. Open CAPAs in spreadsheets are listed.
- 02
Configuration
8D/CAPA templates, audit checklists, the defect-code tree and control plans are set up; roles come from the directory (AD/IdP), approval steps are defined in the Workflow engine.
- 03
Data migration and integration
Open CAPAs and audit history are migrated; ERP/MES lot and work-order links, measurement devices (CMM, scales) and the supplier portal are connected.
- 04
Go-live and training
Live with a pilot line or plant; the quality team and operators are trained, Pareto and CAPA closure-time reports are reviewed together in the first month.
Start with one module, grow on the shared platform
All 12 modules share the same user directory, authority matrix, workflow engine and audit trail; they run on-premise or in your own cloud.
Runs in-house
Quality records, customer complaints and measurement data never leave the company; the module runs on-premise or in your own cloud. KVKK rules and retention periods apply.
Role-based permissions
Operators enter measurements, quality engineers run CAPAs, the quality manager closes them, auditors read only; suppliers see only their own record on the portal. The authority matrix is shared with the other modules.
Immutable audit trail
Every CAPA step, measurement and document version is kept with who-and-when; exportable for the audit body. Process structure aligned with ISO 9001 / IATF 16949; the certificate itself is issued by the audit body.
Shared platform
The same user directory and workflow engine as Asset & Inventory (device calibration), Workflow (approval steps), Procurement (suppliers) and the other modules; start with one module.
The Quality module works together with assets, workflow and operations
Asset & Inventory ManagementCalibration dates of measurement devices come from the asset card; a measurement taken with an overdue device is flagged.
Workflow & Approval EngineCAPA actions, closure approval and document publishing flow through this engine's approval and SLA rules.
Operations & Logistics AgentSees recurring defects and the effect of a quarantined lot on the production plan ahead of time and proposes re-planning.Common questions
Does it prepare us for IATF 16949 / ISO 9001 certification?
Processes are set up in alignment with these standards: CAPA/8D, audits, document control and record traceability produce the evidence the audit body looks for. The certificate itself is issued by an independent audit body; the module is not a certification promise but the infrastructure for preparation and maintenance.
Does it connect to our measurement devices?
CMMs, scales, calipers and sensors are connected according to their output format (file, serial port, OPC UA, MES); an operator form is used for devices without a connection. The device list is drawn up in discovery and a connection path is set for each.
Can we send a CAPA to a supplier?
Yes. A supplier nonconformity is forwarded through the portal, an 8D response is requested in the same format; response time and quality are scored and accumulate on the supplier card. The supplier sees only its own record.
Does it connect to our existing ERP/MES?
Yes. Lot, work-order, material and supplier data are read from the ERP/MES; quarantine and scrap decisions can be written back. Where each piece of data lives is drawn in discovery.
On-premise or cloud?
Both. Because quality data and customer complaints are sensitive, most customers prefer on-premise or their own cloud; the architecture is the same.
Do we have to buy it together with the other modules?
No. The Quality module works on its own; the workflow engine needed for approval steps is included. Asset & Inventory (calibration) and Procurement (supplier portal) are added to the same platform later.
What happens to our open CAPAs in spreadsheets?
They are listed in discovery, mapped to the template and migrated with their open status; closed records are optionally loaded as history. This way the Pareto and recurring-defect analysis cover the past from day one.
Let's close one of your open CAPAs together
In a 30-minute demo we work one of your hardest nonconformities (customer complaint, audit finding, supplier defect) through the 8D card together; see the root cause, action and verification steps live.