11.1 Are there written procedures on how to handle non-conforming, returned and rejected lots?

11.2 Is there a procedure ensuring that non-conforming materials are prevented from reintroduction into market unless downgraded or reprocessed?

11.3 Are activities with non-conforming products documented (including downgrading and disposition)?

11.4 Are product non-conformances investigated including consideration of other batches?

11.5 Is feedback from customers entered into the non-conformance system?

11.6 11.6
Is there a procedure in place to prevent blending of non-conforming materials with compliant materials?