USE CASE · QUALITY

Quality is not a checkpoint — it is the process itself.

Quality is managed through defined checkpoints at goods-in, during production and before dispatch. When a measurement breaches a control limit, the system flags the deviation instantly, links the non-conformance to the batch and starts the corrective action. The outcome is not a certificate but a repeatable process. From the recorded quality values, the certificates of analysis customers ask for at dispatch are generated automatically. Alongside this, CAPA documents are raised for problems found in production and the resulting actions are followed through.

Non-conformance rate

1.42%

target ≤ 2.00%

Return rate

0.85%

target ≤ 1.00%

PPM

850

target ≤ 1,000

Quality score

93.6

target ≥ 90

PROCESS CONTROL · SPC

The moment a measurement breaches the limit, it shows.

Measurement Average UCL / LCL
UCL +40 LCL −40
Measurement 18 · point exceeded the UCL → a non-conformance record opened automatically and the batch was quarantined.

QUALITY MANAGEMENT FLOW

From control plan to decision — two paths.

Control plan What is measured, where and how is defined
Sample / measurement A sample is taken and the measurement recorded
Incoming quality Incoming material is inspected
Process quality Monitored during production
Final inspection Pre-dispatch verification

Conforming → Approve / Release

If the result is within the acceptance range, the batch is released and recorded. The product moves to the next operation or to dispatch; the approval is stored with an electronic signature.

Non-conforming → Corrective action

If the result is out of limit, a non-conformance record is opened and the batch is quarantined. Root cause analysis and corrective action begin, and the process is tracked to closure.

QUALITY CHECKLIST

Every batch goes through the same steps.

Document control
Measuring equipment calibration
First-article approval
In-process control
Final inspection
Records and traceability

WHAT DOES QUALITY BRING?

Early warningA deviation is reported the moment it crosses the limit; action comes before the problem grows.
Root causeEvery non-conformance is traced down to the production record; recurrence is prevented.
Continuous improvementData-driven analysis; the quality process improves itself over time.
Audit-ready recordsEvery inspection is stored with time and user; ready at audit.

The quality module is set up to hold the process records standards such as ISO 9001 require; certification remains the organization's responsibility. Figures on this page are demo data.

YOU'VE COMPLETED THE USE-CASE TOUR

Let's build quality into your own process.

Let's define your checkpoints, acceptance criteria and non-conformance process together, so quality becomes a working system rather than a report.

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