How are visual inspection defects classified as critical, major and minor?

Visual inspection defects are classified by the risk they pose to the patient and product into three grades: critical, major, and minor.

Critical defects pose a safety or sterility risk and are rejected without exception --- glass particles, metal particles, cracks, and seal or closure failures fall here. Major defects affect product quality, function, or dose but are not immediately life-threatening --- embedded particles, fibres, hair, and fill-volume deviations are typical. Minor defects are cosmetic, affecting appearance only --- light stains, minor scratches, and slight colour variation. This classification drives the acceptable quality limit (AQL) applied to each defect type and determines how a Knapp challenge set is weighted, because inspection processes must be qualified most rigorously against the critical defects.

FTI's defect matrix assigns each defect type its grade and the number of challenge units per grade, so a facility's inspection qualification reflects real risk rather than treating every defect the same. This post is the hub for the defect cluster --- it links to the particle, fibre, cosmetic, crack, seal, and fill posts.