After label preparation, Engineering Services will forward the labeling documentation with a Labels Labeling Approval Template to the originating department. The labeling and ENG103-1 APPROVAL FORM FOR LABELS AND LABELING should be circulated through Engineering, Customer Service, Marketing, and Quality Assurance.
Engineering Services will coordinate and track all label approvals and approval forms. Upon approval, the label or manuscript is assigned a drawing number and is released and added to the device master record file and DMR index. When the labels or labeling is produced or printed, Quality Control must inspect the material in accordance with receiving procedures and proofread the material and verify that it is correct and so indicate by signing an appropriate document (first article inspection).