Managing the Design History File
Windchill CAPA, Windchill Nonconformance, Windchill Customer Experience Management are key components in the Design History File (DHF) for medical devices.
Include Objects in the DHF
If an object does not have the DHF Category attribute assigned, it is included in the DHF by default.
The presence and value of the DHF Category attribute determine whether an object is included in or excluded from the DHF.
The inclusion of an object in the DHF depends on the presence and value of the DHFCategory attribute:
• If the attribute is not present, the object is included in the DHF by default.
• If the attribute is present and has a non-null value, the object is included in the DHF.
• If the attribute is present and the value is null, the object is excluded from the DHF.
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When new objects (such as parts or documents) are added to a part structure, their inclusion in the DHF depends on whether the DHF Category attribute is defined and how it is set. Objects with a null value are excluded, while objects with a value or without the attribute are included.
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Exclude Objects from the DHF
You can exclude any object, including Windchill CAPA, Windchill Nonconformance, and Windchill Customer Experience Management from the DHF by adding and configuring the DHF Category attribute.
To exclude objects:
• Determine the objects to exclude from the DHF, including Windchill CAPA, Windchill Nonconformance, and Windchill Customer Experience Management.
• Add the DHF Category attribute to each object type and leave the attribute value null for objects that you want to exclude from the DHF.
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• Although a global attribute named DHF Category exists in QMS_PDS, it is recommended to use a local IBA.
• The internal name for the DHF Category attribute must match DHFCategory, including uppercase and lowercase letters.
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