Supplier programs commonly fail in one of two directions: every supplier receives the same intensive treatment regardless of risk, or qualification consists of a questionnaire filed and never revisited.
Classify by risk, then act accordingly
- Material criticality and effect on product quality
- Whether the supplier performs a GMP operation on your behalf
- Availability of alternative sources
- Compliance history and prior performance
- Complexity of the material or service supplied
Quality agreements should describe reality
An agreement that assigns responsibilities neither party performs is worse than none. Review agreements against how the relationship actually operates, especially notification of deviations and changes.
Monitoring closes the loop
Qualification is a starting condition. Performance data, complaint history, change notifications and periodic reassessment determine whether the supplier remains qualified.