🇦🇺Australia

Audit-Triggered Production Halts from DMR Gaps

1 verified sources

Definition

Failure to produce complete DMR on demand leads to mandatory production stops, causing lost sales and equipment idle time.

Key Findings

  • Financial Impact: AUD 5,000 - 20,000 per day production halt; 20-40 hours record retrieval per audit[7]
  • Frequency: Per TGA inspection request
  • Root Cause: Decentralized manual DMR storage, poor indexing

Why This Matters

The Pitch: Australian medtech companies lose AUD 10,000+ daily in idle capacity from DMR audit shutdowns. Real-time DMR automation prevents inspection delays.

Affected Stakeholders

Operations Manager, QA Auditor

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Financial Impact

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Current Workarounds

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Methodology & Sources

Data collected via OSINT from regulatory filings, industry audits, and verified case studies.

Evidence Sources:

Related Business Risks

TGA Non-Compliance Fines for DMR Deficiencies

AUD 10,000 - 500,000 civil penalties per breach; 40+ hours per audit remediation[2][7]

DMR Errors Triggering Warranty Claims

2-5% of revenue in warranty claims and rework; AUD 50,000+ per batch recall[5]

Rework from CAPA Delays

AUD 5,000 - 20,000 per major CAPA event in rework costs; 2-5% production scrap increase

TGA CAPA Non-Compliance Fines

AUD 20,000 - 100,000 per TGA enforcement action; 100-500 hours per CAPA audit remediation

Bußgelder wegen verspäteter Meldung von Vorkommnissen an die TGA

Logic-based estimate: AUD 50,000–150,000 per significant late or missed MDR case in combined legal, internal investigation, consultant, and recall-preparation costs; plus risk of additional civil penalties set under the Therapeutic Goods Act 1989.

Überhöhte interne Kosten für manuelle Bearbeitung von Beschwerden und MDR‑Bewertungen

Logic-based estimate: AUD 800–1,800 internal labour cost per escalated or potentially reportable complaint; equating to roughly AUD 120,000–540,000 annually for 150–300 such complaints at a mid‑size manufacturer.

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