Skip to main content

πŸ“˜ Full Guide: Traceability in Manufacturing with Next Plus

Alex Merkin avatar
Written by Alex Merkin
Updated over 2 weeks ago

What this is

Traceability means knowing exactly who did what, when, and on which part, unit, or batch.
It is the backbone of modern manufacturing β€” ensuring compliance, quality, and trust.

With Next Plus, you can digitize traceability end-to-end, replacing paper logs and disconnected systems with a single source of truth. This guide explains how traceability works, why it matters, and how Next Plus makes it easy.

Why Traceability Matters

Traceability ensures:

  • Regulatory compliance – Required by AS9100 (aerospace), ISO 13485 & FDA 21 CFR Part 11 (medical), IATF 16949 (automotive), ISO 22000/HACCP (food & beverage).

  • Quality assurance – Links defects back to root causes to prevent recurrence.

  • Audit readiness – Provides evidence instantly during inspections.

  • Customer confidence – Shows that processes are standardized, controlled, and trustworthy.

⚠️ Without traceability, risks include failed audits, recalls, and loss of customer trust.

Common Challenges Without Traceability

Challenge

Impact

Example

Paper-based logs

Errors, missing records

Operator forgets to sign a step β†’ QA cannot prove compliance in an audit

Disconnected systems (ERP, QA, machines)

Gaps & duplication

ERP shows 20 units, warehouse logged 18, QA has no record

Outdated revisions

Scrap, rework, compliance failure

Operators still use Revision A when Revision C is required

Subcontractor blind spots

Lack of visibility

Supplier builds to old instructions; defects discovered at shipment

✨ Next Plus eliminates these gaps by digitally connecting all records, workflows, and approvals.

The Next Plus Approach to Traceability

  • πŸ”Ή Digital-first traceability – All actions logged with 21 CFR Part 11–compliant e-signatures.

  • πŸ”Ή Unit- and batch-level reporting – Supports serial and batch reporting, or both.

  • πŸ”Ή Contextual data capture – Workflows tie together instructions, operator input, ECOs, QC, and machine data.

  • πŸ”Ή Built-in compliance – Standards like AS9100, ISO, and FDA requirements are met automatically.

  • πŸ”Ή Audit trails – Automatically generated and ready for export.

How Traceability Works in Next Plus

1. Digital Work Instructions with Signatures

  • Every workflow step requires login and signature.

  • Signatures are timestamped, tamper-proof, and linked to the individual.

  • Supports multi-level approvals (Operator β†’ QA β†’ Supervisor).

2. Engineering Change Orders (ECO)

  • Latest revision updates are instantly available across all active workflows.

  • Logs show who approved the ECO, when, and what changed.

3. Evidence Collection

  • Operators can attach photos, videos, barcodes, or measurements.

  • AI-enabled fields auto-extract values (e.g., weight from a scale).

4. Rework & Nonconformance Handling

  • Failed steps branch automatically into Rework, Scrap, or Hold.

  • NCRs are tied directly to the affected unit.

  • The full rework chain (who flagged, who fixed, who approved) is recorded.

5. Full Audit Trail

  • Each Session generates a detailed log:

    • User

    • Timestamp

    • Action (start, pause, approve, reject)

    • Collected data (forms, notes, media)

  • Exports are available as Device History Records (DHRs) or Batch Reports.

Real-Life Use Cases

πŸ₯ Medical Devices – A weld defect was traced to a missed calibration. Next Plus linked every weld to the tool ID, allowing QA to isolate affected batches before shipment.

✈️ Aerospace – During an AS9100 audit, the auditor required unit-level proof. Next Plus produced a full log of signatures, ECO revisions, and QA approvals. The audit passed with zero findings.

⚑ Electronics Assembly – Operators uploaded solder joint photos. QA signed off remotely, avoiding shipment delays and travel costs.

Best Practices for Maximizing Traceability

  • βœ… Define critical steps β€” not every action needs a signature.

  • βœ… Enforce calibration control β€” prevent tool usage if calibration expired.

  • βœ… Require visual proof β€” photos and videos eliminate disputes.

  • βœ… Apply strict ECO enforcement β€” no outdated revisions.

  • βœ… Run internal audits β€” export and review reports before regulators do.

Common Questions

Q: Does traceability slow down production?
No β€” signatures and data entry are built into workflows, not separate tasks.

Q: Can subcontractors use the same system?
Yes β€” subcontractors log into Next Plus and follow assigned workflows. Managers see progress live.

Q: How long are records stored?
Indefinitely β€” records remain available for audits, customer requests, or analysis.

Q: What if multiple workers share one step?
Next Plus logs partial reports: Worker A signs the start, Worker B signs completion.

Conclusion

Traceability is more than a compliance checkbox β€” it is the foundation of reliable, high-quality manufacturing.

With Next Plus, you gain:

πŸ“Š End-to-end visibility over every unit and process
βœ… Compliance built in to every workflow
πŸ”Ž Audit readiness at any moment
⚑ Faster root-cause analysis
🀝 Customer trust through transparency

Did this answer your question?