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

6、xers,tools5.Molds6.Machine maintenance procedures7.Calibration procedures8.Setup procedures9.Operating procedures10.Process flow charts第5页/共14页DMR3.8Sterilization procedures1.Procedures for ethylene oxide,radiation,filtration,steam,etc.2.Handling and flow procedures3.Cycle parameter specifications4.

7、Diagrams for loading products in the chamber第6页/共14页DMR3.9Production control documentation1.Inspection procedures2.Test procedures3.Blank job travelers4.Blank inspection/test forms5.Instrument charts6.Reporting forms第7页/共14页DMR4.0Labeling and Packaging4.1Index(Optional.see 1.0 above.)4.2Labeling1.La

8、bel drawings2.Labeling drawings3.Label/labeling review procedures and forms4.Production control procedures and history record forms5.Instruction manuals6.Service manuals7.Customer software8.Customer feedback forms第8页/共14页DMR4.3Packaging1.Package drawings(usually includes labeling information)2.Closu

9、re drawings3.Filling and/or packaging procedures4.Packing procedures5.Special shipment procedures4.4Storage requirements1.Temperature2.Humidity3.Shelf life第9页/共14页DMR5.0Control Procedures and Activities5.1Index(optional.see 1.0 above.)5.2Inspection procedures1.Incoming2.In process3.Finished devices4

10、.Process control charts5.Blank data reporting forms第10页/共14页DMR5.3 Test procedures1.Incoming2.In process3.Pretest conditioning4.Finished device5.Process control charts6.Blank device history record forms7.Automated test programs and/or software第11页/共14页DMR6.0Final Release6.1Release document review list6.2Distribution procedures6.3Blank device history record forms第12页/共14页DMR产品主文档产品实现过程程序/作业指导书记录部门UL/QP-01UL/WI-03采购IQC第13页/共14页感谢您的欣赏！第14页/共14页