What’s New > Windchill > 11.0 M020 > Optionally Enabled Features > Windchill Quality Solutions: Design History File and Device Master Record
  
Windchill Quality Solutions: Design History File and Device Master Record
Product: Windchill, Windchill Quality Solutions, Windchill CAPA, Windchill Customer Experience Management, Windchill Nonconformance
Release: 11.0 M020
Benefit
The new design history file and device master record features allow customers to view and report on all design artifacts for a medical device in one place, reducing the risk of noncompliance.
Additional Details
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 also contains workflows, design documents, design reviews, and test plans.
A design 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).
In Windchill, you can interact with the DHF and DMR in the following ways:
You must configure the information page for a part before you can view information for the DHF and DMR. Create a new tab and select Customize > Quality > Design History File or Customize > Quality > Device Master Record.
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.
You can add information to a DMR by selecting Actions > Add to Device Master Record.
You can manually create or update the DHF by selecting Create Design History File or Update Design History File from the Actions menu.
The DHF is created automatically through the DHFBuilderQueue. By default, the query is run once a day. You can also manually create a design history file by selecting Actions > Create Design History File.
The file names contain the number, name, revision, and type of file (DHF or DMR).
Even if a file is deleted, it remains part of the DHF. This way, you can see the progress of a part structure over time and track the design maturation for a product.
Related Information
For more information, see Using the Design History File and Design Master Record.