Quality that is recorded, acted on, and ready to trace
Quality management is more than recording inspection results. When a deviation occurs, the system can raise a non-conformance, hold the affected unit, and keep the entire history in a record that can be verified.
What quality and traceability cover
- Non-Conformance Management Record deviations in real time, from operator input or automatically when a measurement falls outside specification. Every non-conformance follows an Open → Investigation → Disposition → Closed flow, with auto-hold based on severity.
- End-to-end genealogy and traceability Trace a product backward to its raw material lots and forward to its final product or destination. Splits and merges stay recorded, including the comparison between the material that should have been used and what was actually consumed.
- Rule-based production transactions Every activity (move, consume, scrap, rework, hold/release, split, merge) runs under the rules of the process. Where an exception arises, an override still requires a reason and is recorded in the audit trail.
- Real-time inventory control The inventory ledger updates at lot and location level as transactions happen. The system supports FIFO, FEFO, or manual allocation, QA quarantine controls, and blocks the use of expired or non-compliant stock.
- Batch and unit records ready for audit An EBR summarises the material, process, and signature history for a batch. An EDHR gives the same level of detail for a single unit, while a generic report covers any production view or time range. Every document is hashed at generation, so the export can be verified.
Non-conformances follow a clear flow
Every deviation has a clear process from start to finish. Status changes are recorded, and closing one requires a signature where the rules demand it.
| Stage | What happens |
|---|---|
| Open | Recorded by an operator, or created automatically when a data collection result falls outside specification. |
| Under review | The team triages severity, the non-conformance code, and the affected units. |
| Investigation | The root cause is traced and supporting evidence is recorded on the same record. |
| Disposition | Decide the action, whether use as-is, rework, reprocess, scrap, or reject, with QA sign-off where required. |
| Closed | The non-conformance is closed with a signature, and its entire history remains in the audit trail. |
Auto-hold when the system finds a problem
- Out-of-specification results raise an NC automatically When a data collection result falls outside its defined limits, the system can raise a non-conformance without waiting for an operator to notice it first.
- Critical severity holds the unit immediately The affected batch or lot cannot continue through the process until the hold has been handled according to procedure.
- Expired stock cannot be consumed Expired lots are blocked from consumption. If an operator chooses a lot outside the FEFO or FIFO recommendation, the reason must be recorded.
Evidence that can be verified independently
- Hash-chained signatures Every signature is cryptographically linked to the record before it, so a change to an older record can be detected through the hash chain.
- The audit trail is append-only The audit trail provides no edit or delete path, administrators included. Append-only is part of the system design, not a permission that can be changed.
- Verification without a login Exported documents carry a hash that a third party can use to check the document's integrity without holding an account on the system.
- EBR and EDHR ready to export Material, process, and signature history can be exported as documents carrying their integrity information, so the result stays verifiable after it is printed or shared.