Excessive Testing and Audit Costs
Definition
Supplier qualification demands documentation reviews, questionnaires, CoA verification, and full testing of initial deliveries. On-site audits may be required, inflating costs until reduced sampling is validated.
Key Findings
- Financial Impact: AUD 1,000-5,000 per supplier qualification (questionnaires, 3 full tests at AUD 300-1,000 each, audit travel)
- Frequency: Per new vendor or status downgrade (e.g., on test failure)
- Root Cause: Lack of digital tools for questionnaire automation, audit tracking, and test data trending
Why This Matters
The Pitch: Packaging firms in Australia spend AUD 10,000-50,000 yearly per critical supplier on mandatory full testing. Automation streamlines qualification to enable reduced sampling sooner.
Affected Stakeholders
Quality Unit, Purchasing, QA Auditor
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:
- https://www.tga.gov.au/sites/default/files/supplier-assessment-approval-and-qualification-listed-and-complementary-medicines.pdf
- https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/australia/supplier-qualification---industry-and-regulator-perspective.pdf?sfvrsn=4
- https://www.pharmout.net/supplier-qualification-ensuring-high-quality-suppliers/
Related Business Risks
Cost of Poor Quality from Unqualified Vendors
GMP Non-Compliance Fines for Vendor Failures
Cost of Poor Quality
Capacity Loss
Cost Overrun
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