Kosten durch mangelhafte Lieferantenaudits und Rückrufrisiken

Definition

ISO 13485 and the MDSAP audit approach explicitly require medical device organisations to exercise proper control over outsourced processes and critical suppliers, including through qualification, monitoring and re‑evaluation.[2][5] MDSAP guidance notes that auditors may extend audits to external suppliers where controls are critical to meeting regulatory requirements.[5] Industry guidance for medical device supplier management emphasises that Tier One and Tier Two suppliers should be audited before approval and then every 1–3 years based on risk and performance, with monitoring of supplier performance feeding into re‑evaluation.[4] When supplier audits are superficial, infrequent or poorly documented, critical nonconformities can remain undetected until they manifest as device defects, nonconforming lots or complaints, requiring scrap, rework, additional testing and sometimes field corrective actions. While Australian‑specific cost figures are rarely published, international benchmarking for medical device manufacturers typically places the cost of poor quality (COPQ) at 2–5% of sales, with supplier‑related failures representing a substantial share. For a manufacturer with AUD 20–50 million in annual Australian turnover, this implies AUD 400,000–2.5 million in avoidable cost annually attributable to inadequate supplier control, part of which is directly driven by immature supplier qualification and audit processes.

Why This Matters

The Pitch: Medical equipment players in Australia 🇦🇺 lose 2–5% of device revenue on scrap, rework and complaint handling linked to poorly controlled suppliers. Automation of risk‑based supplier qualification, performance monitoring and audit follow‑up reduces defects at incoming inspection and downstream failure costs.

Affected Stakeholders

Quality Manager, Supplier Quality Engineer, Regulatory Affairs Manager, Head of Manufacturing, Operations Director, Risk Manager

Related Business Risks