🇦🇺Australia

Rework from CAPA Delays

2 verified sources

Definition

CAPA management failures cause ongoing production waste and quality escapes in medical equipment manufacturing.

Key Findings

  • Financial Impact: AUD 5,000 - 20,000 per major CAPA event in rework costs; 2-5% production scrap increase
  • Frequency: Per production batch non-conformity
  • Root Cause: Manual CAPA handling creating bottlenecks and idle equipment

Why This Matters

The Pitch: Australian medical device makers incur AUD 50,000+ yearly in CAPA rework waste. Streamlined CAPA automation reduces scrap by 20-30%.

Affected Stakeholders

Production Manager, Process Engineer, Quality Technician

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

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.

Teure Rückrufe und Korrekturmaßnahmen durch verspätete Trendanalyse von Beschwerden

Logic-based estimate: AUD 200,000–1,000,000 total cost for a large‑scope device recall in Australia triggered late due to poor complaint trend detection (field service, logistics, replacement, and administration).

Kapazitätsverlust durch doppelte Meldungspflichten (Hersteller, Sponsor, Krankenhäuser)

Logic-based estimate: 200–800 specialist hours per year lost to duplicate processing and reconciliation of hospital and sponsor reports, equivalent to roughly AUD 16,000–96,000 annually in staff cost for a mid‑size manufacturer.

Kosten durch mangelhafte Rückverfolgbarkeit in Design History Files

Estimated: AUD 50,000–200,000 per product line over its lifecycle in avoidable verification/validation, test, and engineering rework caused by incomplete or poorly structured DHF traceability.

Request Deep Analysis

🇦🇺 Be first to access this market's intelligence