Supplier risk management
Risk-based process of qualifying, monitoring and re-evaluating suppliers based on the criticality of what they supply and their performance history.
21 CFR 820.50, ICH Q10 §2.7, ISO 13485 §7.4.1 and every GFSI scheme require purchasing controls proportionate to supplier criticality. A defensible programme classifies suppliers (Critical/Major/Minor), defines qualification activities for each tier (questionnaire, document review, on-site audit, sample testing), sets re-evaluation frequency, monitors performance via scorecard, and triggers requalification or disqualification on threshold breaches.
V5's supplier portal collects qualification documents (CoAs, ISO certs, FSMA training, allergen statements) on a schedule, scores expirations, and routes incoming-inspection failures into NCR/CAPA automatically.
- 21 CFR 820.50
- ICH Q10 §2.7
- ISO 13485 §7.4
- FSMA Subpart G
Free trial, no credit card, onboard in days, not months.