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Using the Design History File and Device Master Record
Design History File
A design history file (DHF) is the collection of artifacts used in the design process for a finished medical device. The design history file contains information related to a part structure (reference documents, change notices, change records, problem reports, variances, and so on). It contains anything that a managed baseline can contain.
The Design History File Objects table on the information page renders all the objects in the DHF baseline where the current part revision combination is the primary object. The table filter includes all objects by default and allows configuration to add additional filters. You can filter by category, the type of object, and the state.
To view the Design History File Objects table, do the following:
1. On the information page for a part, create a new tab.
2. Select Customize > Quality > Design History File.
To manually refresh the Design History File Objects table, select Actions > Update Design History File.
To manually create a DHF, select Actions > Create Design History File. The system creates a DHF baseline file with the current part as the primary object. The file contains items associated with the object, such as change notices and documents. The file appears in the Design History File Objects table.
If a described by or referenced document is removed from a part, or a subpart is removed from a tree structure, the removed document or subpart remains in the DHF. This way, you can see the progress of a part structure over time and track the design maturation for a product. If a document or part itself is deleted, it does not remain in the DHF.
You cannot delete the primary object for a DHF.
The DHF is created automatically through the DHF builder queue (DHFBuilderQueue) using the com.ptc.qualitymanagement.qms.dhf.dhfBuilderSchedule property in the wt.properties file. By default, the value for this property is 00\:30,1,DAY for the DHF builder to run at 12:30 a.m. daily. Examples for this property include the following:
com.ptc.qualitymanagement.qms.dhf.dhfBuilderSchedule=00\:30,2,DAY
com.ptc.qualitymanagement.qms.dhf.dhfBuilderSchedule=15\:30,12,HOUR
com.ptc.qualitymanagement.qms.dhf.dhfBuilderSchedule=23\:00,5, MINUTE
Device Master Record
A device master record (DMR) is the compilation of all the information used to produce a device. It contains the bill of materials (all the materials used to construct a product) and the bill of operations (all the processes used to manufacture, distribute, and service the product).
The Device Master Record Objects table on the information page contains objects in the DMR. The table is configurable but not editable.
To view the Device Master Record Objects table, do the following:
1. On the information page for a part, create a new tab.
2. Select Customize > Quality > Device Master Record.
Because the DMR only contains approved objects, the DMR is not synchronized with the DHF. To add objects to a DMR, select the objects from the Design History File Objects table. Select Actions > Add to Device Master Record. The objects appear in the Device Master Record Objects table.
If a DMR exists, the elements are added to the existing DMR. If a DMR does not exist, the system creates a new DMR with the name, number, and revision of the part as the name of the DMR.
Exporting DHF and DMR Information
You can export DHF and DMR tables to all exportable formats including PDF and Excel. To export this information with a cover page, select Actions > Export List to File > Export List to PDF with Cover Page. The cover page includes the name of the report generator and the time that the report was generated. It also includes the part name, part number, version, and context.
To learn more about PTC Solutions for Medical Device Innovators, see PTC.com.