If you rely on a packaging vendor for critical launches or medical device products, you should know how they operate. Use this supplier audit checklist as a practical starting point.
Quality & Compliance
- Documented quality management system (e.g., ISO 9001, ISO 13485)
- Change control procedures for materials and processes
- Traceability of materials and lots
- Corrective and preventive action (CAPA) process
Production Capabilities
- Core substrates and formats they run well
- Print technologies available (digital, offset, flexo)
- In-house vs. outsourced finishing (foil, embossing, coating)
- Capacity and lead-time norms for your volumes
Documentation & Data
- Specification and drawing management
- Inspection and test records
- Certificates of analysis when needed
- Support for validation testing (for medical devices)
Communication & Service
- Named account manager or technical contact
- Typical response time for emails and RFQs
- Project management tools or methods
Want Support Conducting a Supplier Audit?
Influence Packaging can help plan and execute supplier audits, especially for Bay Area and regulated companies.