I'm fairly new in ceating a QMS and I have been tasked to improved our change control system. I have used QCBD software in the past and have had no issues opening a change order, determining the risk level from FMEA's, knowing what documents needing changes, if a validation is required, implementing tasks, uploading redlines and sending out the approvals through document control. I used the design risk assessment for critical changes under 510 (k) 2017 and presented this checklist but the TEAM felt it was good for design changes only for new products. Our system is all paper based until the final version of a document is loaded in Master Control and group training is signed off. The issue at hand is changes are being requested all the time, change order request forms are being filled out and process change order numbers are being given out on the PCR form with missing tasks for the implementation plan. Forms aren't being fully filled out and activities are begining. I'm responsible to get the change control process under control and was asked to create a decision tree that is super high level where the employee won't misinterpret the questions to go to the yes/no section of the decision tree and they will know if an SOP is required, a document needs updating, a validation is required and I need to set up whether it is a minor, major or critical risk. Currently we don't have FMEA's so I'll take any advice please. The decision tree is the largest task at hand per bosses request. Thanks!