🇦🇺Australia

Cost of Poor Quality

3 verified sources

Definition

PRAC simplifies recalls but mandates strict reporting; failures trigger penalties, adding to quality failure costs like rework and refunds.

Key Findings

  • Financial Impact: AUD 50,000+ per non-compliance incident (fines, legal action); 20-40 hours per recall event on manual steps
  • Frequency: Per recall event, mandatory for all sponsors
  • Root Cause: Complex manual processes in legacy URPTG (10 steps reduced to 5 in PRAC), risking delays

Why This Matters

The Pitch: Medical equipment manufacturers in Australia waste AUD 50,000+ per recall event on manual compliance and penalties. Automation of recall notifications and tracking eliminates this risk.

Affected Stakeholders

Recall Coordinators, Compliance Officers, Sponsors

Deep Analysis (Premium)

Financial Impact

Financial data and detailed analysis available with full access. Unlock to see exact figures, evidence sources, and actionable insights.

Unlock to reveal

Current Workarounds

Financial data and detailed analysis available with full access. Unlock to see exact figures, evidence sources, and actionable insights.

Unlock to reveal

Get Solutions for This Problem

Full report with actionable solutions

$99$39
  • Solutions for this specific pain
  • Solutions for all 15 industry pains
  • Where to find first clients
  • Pricing & launch costs
Get Solutions Report

Methodology & Sources

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

Evidence Sources:

Related Business Risks

Compliance Penalties

AUD 100,000+ in financial penalties per violation; potential TGA registration revocation

Administrative Cost Overrun

AUD 20,000-50,000 per recall in admin costs (20-40 hours/phase at AUD 100/hr)

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.

Request Deep Analysis

🇦🇺 Be first to access this market's intelligence