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 > > or > > .
• You can export DHF and DMR tables to all exportable formats including PDF and Excel. To export this information with a cover page, select > > .
• You can add information to a DMR by selecting > .
• 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 > .
• 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.
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