What happens with projects that are currently being carried out when the Quality System for the company changes drastically? Is there a certain time where a project has just reached a point where it can be considered “grandfathered” into the previous system or handled slightly differently than a brand new project? What if the project is already completed, i.e. the DHF is complete and Design Transfer is complete and there is a change to the way the DHF’s are handled? Is it necessary to go back and redo all of the old DHF’s?

Obviously this could potentially lead to some delays in completing a project if you had to continuously go back to follow new changes, regardless of what stage of the project you were in or how close you were to being done. However the real answer varies per company. What are your thoughts on how this challenge should be tackled?