Upon compilation of all documents to be included in the Master Record, a Device Master Record Index Template should be prepared to identify all items in the record and location(s) of these records. ENG104-2 DEVICE MASTER RECORD INDEX includes descriptions such as product specification and product literature.
Upon completion of the design phase of a device, a formal document plan will be initiated and will be called the Device Master Record. The configuration and structure of the master record is determined by the Engineering and Manufacturing managers. After agreement, the master record will be created, document numbers assigned, status of drawings indicated and the record approved by Engineering and Manufacturing.