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  • ap962 replied to the topic Engineering change order in the forum Project Management Process and Medical Device Development 7 years, 1 month ago

    The objective of ECOs and any other change orders is to legitimately archive the proposed changes for tracebility purposes. Any necessary changes of the design or documentation go through COs. The COs are reviewed and sent to the necessary dpartments for further approval. There is a possibility of alteration of the CO based on the input recieved from various department.The redlined documentation which has been changed is also included so that changes made can be easily evaluated by approvers and auditors.
    A series of protocal needs to be followed in order for these changes to go through and for the documents to be verified. The final draft is reviewed by the companys documentation department and then recieves approval for the final change.