🇦🇺Australia

Excessive Contract Variations

1 verified sources

Definition

Inadequate monitoring of service contract changes results in cost overruns from disputes, additional supplier fees, and rushed compliance.

Key Findings

  • Financial Impact: AUD 20,000+ per major contract in variation costs (20-40 hours/month manual effort)
  • Frequency: Per contract amendment
  • Root Cause: Lack of automated variation tracking

Why This Matters

The Pitch: Medical Equipment Manufacturing incurs AUD 20,000+ yearly in variation disputes. Automation of change management reduces overruns.

Affected Stakeholders

Procurement Managers, Contract Managers

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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

Unbilled Service Extensions

2-5% of annual service revenue (AUD 100,000+ for typical firm)

TGA Non-Compliance Fines

AUD 222,000 civil penalty per serious breach (TGA maximum)

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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