A DHF is a design history file which is a formal document that is prepared for each document. The DHF contains all the documents needs to produce the product. It contains all the design stuff along design review meetings and every small thing required. It should contain all the SOP’s required for it and all the documents should have the current revision in the file. To ensure that the DHF is audit ready, make sure all documents are in order and have the updated revision(printed and electronically) and the training for the SOP’s is done also. One key factor is for any audits to have everything ready to be given but should not give out too much information. Only give what the auditors are asking for. That is the main thing I have learned from participating in the previous audits. Audits maybe be overwhelming but having everything proper will ease the auditing.