04 / Acceptance and handover
Prove the result under a representative production condition
Execute a risk-based plan and trace every sample to process history, methods, limits and lot disposition. Retain measured evidence for critical product and package attributes and method, quantity and release use with method, position, limit, deviation, witness, approval and requalification trigger. Map product and package temperature by time and position with calibrated measurements, challenge line stops and thermal disturbances, verify closure contact, container dimensions, vacuum or pressure, seal integrity and product quality, and retain approved deviation and release decisions. Put the sample or test material, method, instrument, production state, duration, limit, witnesses, retained record and deviation authority in the protocol before testing begins. Requalify when a product, package, site, speed or connected system invalidates the accepted basis.