8.1 Does the company operate a complaint procedure that describes actions to be taken?

8.2 Does the complaint procedure contain recall criteria?

8.3 Are complaints recorded and investigated to identify the origin and reason?

8.4 Are other batches considered during an investigation of a complaint?

8.5 Are appropriate follow-up actions including a possible recall taken?

8.6 Is there a procedure ensuring the original manufacturer and customers are informed in case of serious quality problems including recalls?