SECOND PARTY AUDITS • GLOBAL COVERAGE
Know your critical suppliers before their failures become yours
Our critical supplier audits examine the processes and controls that protect your products, customers and regulatory commitments. We support supplier qualification, ongoing monitoring and follow up.
The right fit
Who this service is for
- Medical device manufacturers evaluating critical component or contract manufacturing suppliers
- OEMs managing outsourced special processes, assembly, sterilization or testing
- Organizations responding to recurring supplier escapes, late delivery or ineffective CAPA
- Purchasing and quality teams needing independent evidence from distant supplier sites
Scope & expertise
What we can assess or deliver
- Initial supplier qualification and due diligence based on risk
- Routine supplier surveillance and reassessment based on performance
- Focused process audits of production, traceability, inspection, validation and change control
- Supplier corrective action verification after major quality events
- Remote supplier document and process reviews when appropriate
- Supplier assessments across multiple sites coordinated with qualified local or travelling auditors
A clear way forward
How the engagement works
Define criticality
Review supplied product, failure modes, outsourced processes, applicable requirements and risk.
Set audit criteria
Agree scope, supplier access, confidentiality, criteria, agenda and audit language.
Assess at source
Sample manufacturing records, controls, process validation and actual product traceability.
Report clearly
Provide objective evidence, findings based on risk and supplier follow up priorities.
Verify closure
Review supplier containment, root cause, corrective actions and effectiveness evidence.
Tangible deliverables
Typical project outputs
- Supplier audit plan and criteria matrix
- Independent report with process evidence
- Findings based on risk and supplier qualification input
- Optional follow up verification and supplier action tracking
Global assignments depend on supplier access, travel rules and availability of suitably qualified auditors; onsite attendance is agreed before quoting.
Start a conversation
Request a tailored proposal
Only company name, contact person and email are required. Choose the options that apply; there is no need to write a lengthy specification.