DMR要求学习教程.pptx
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1、DMR1.0Device Master Record Index The device master record Index is a table of contents which is used for convenience.It may be known as a:Device Master Record IndexDocumentation or Device Master Record Unit;Documentation Plan;Product Tree;Documentation Index;Product Structure;orBill of Materials(if
2、it also lists the device master record documents).2.0Device Specifications(Device specifications are described in the chapter text.)第1页/共14页DMR3.0Manufacturing Information3.1Index(Optional.See 1.0 above for total table of contents.)3.2Formulation or top assembly drawing3.3List of components1.List of
3、 ingredients(including grade or type)2.Bill of materials(i.e.,component list usually arranged by subassembly or other sub product level or by process steps)3.Formula3.4 Procurement documentation1.Specifications2.Drawings3.Certificate of compliance requirements4.Supplier Assessment procedures第2页/共14页
4、DMR3.5Device documentation1.Fabrication drawings2.Surface finish procedures3.Subassembly drawings4.Wiring and piping diagrams5.Assembly procedures6.Assembly drawings7.Reference documentationa.Wiring and piping schematicsb.Test specifications8.Sub batch procedures9.Blending or mixing procedures10.Sol
5、ution procedures11.Final formulation procedures12.Software packages第3页/共14页DMR3.6Precautions and special notations1.Apparel2.Cleaning3.Storage conditions4.Filling,mixing conditions5.Hazards and safety precautions第4页/共14页DMR3.7Equipment,lines,and procedures1.Process lines2.Assembly lines3.Vessels4.Mi
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