4.7 Change control and deviations

Supplier Change Control Requirements

What changes require SQ approval: materials, process parameters, equipment/tooling, site, sub-tier process, test method, packaging, firmware/programming method. Required evidence and validation depth.

Deviation and Concession Control

How SQ evaluates risk for a deviation request: defect mechanism, detectability, duration/qty/lot boundaries, extra controls, expiry, post-action review.