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  • srg36 replied to the topic How to ensure your DHF is audit ready ? in the forum Introduction to Design Controls 7 years, 9 months ago

    I agree that consistently updating all DHF documents throughout the project is very critical. I have found from my experience that it is very easy to let these things slip, especially in very dynamic projects with frequently changing team members. In fact, I heard of one project where they did not update their project team assignment form, and an auditor noticed that people were signing documents who were not listed as part of the project team, leading to an audit finding. I think that a good way to check that all DHF documents are updated and audit ready is to conduct internal audits regularly throughout the project. This way it forces the team to keep the documentation up to date.