🇦🇺Australia

Rework and Waste in CAPA Processes

2 verified sources

Definition

CAPA triggered by complaints in personal care manufacturing leads to containment, rework, and scrap, increasing costs in high-volume production.

Key Findings

  • Financial Impact: AUD 20-40 hours per CAPA investigation (quality staff at AUD 100/hr); 5-10% batch value in scrap/rework
  • Frequency: Per complaint investigation (10-50 annually for mid-size firm)
  • Root Cause: Manual documentation and root cause analysis in CAPA, as per global standards applied in Australia

Why This Matters

The Pitch: Personal care manufacturers waste AUD 20-40 hours per CAPA plus 5-10% batch scrap. Automation cuts investigation time by 70%.

Affected Stakeholders

Production Supervisor, Quality Assurance Technician

Deep Analysis (Premium)

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

Cost of Poor Quality from CAPA Failures

AUD 50,000+ per major recall event (rework, refunds, disposal); 2-5% of revenue in quality failures for non-compliant manufacturers

ACCC Fines for Consumer Complaints

AUD 1.1M to AUD 50M per ACCC infringement (max penalty 10x benefits or AUD 10M); typical AUD 100,000+ settlements

Cost of Poor Quality in Batch Production

AUD 20,000-100,000 per year in rework, disposal, and stability testing for SMEs (2-5% of production costs based on industry standards)

Capacity Loss from Quality Rework

AUD 10-40 hours per rework incident (AUD 500-2,000 at AUD 50/hr labor + overhead)

GMP Non-Compliance Audit Failures

AUD 5,000-20,000 per failed GMP audit (re-audit fees, consultant costs, production halts)

AICIS Non-Compliance Fines

Fines up to $10 million AUD for corporations; product recalls and market withdrawal.

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