文档介绍：Item
No. Terms Defination and Requirement
1 First Article Report This is to provide ThermoFisher the opportunity to perform overview checking that supplied parts and/or material will perform as expected in the manufactured product. A First Article is usually required when sourcing a newly designed part, New Supplier, New/Changed Specification,Changed Production Process, New Production Plant, Longer exposure of production
2 BOM BOM: Bill of material. Most updated BOM with correct revision shall be provided. The content shall cover at least part description, part number, quantity, vendor name etc.
3 Drawing Provide the drawing to confirm supplier is using correct revision and under supplier's rev. control
4 Material Certification The material shall conform with Thermofisher drawing and take the expected material supplier
The report covers physical/chemical test results position to ensure no wrong material and degradation are happened.
5 Dimensions Inspection report If supplier conducts inspections for dimension with negative result. However, waiver may be issued by Thermofisher SQE based on overall project consideration.
6 Function
and relaibilty test Function test report is required by customer and drawing. For some critical parts, 100% inspection on all parts are required based on criticality in order not to affect end users to use this product. At the same time, please concern possible something happened to product after the 3F test is conducted, for example: destructive test.
7 Final inspection certificate Final inspection certificate is required supplier inspected all the items base on supplier Standard Inspection Instruction (SIP) and let Mass production is stable and smooth.
The Final inspection report is one summary for all of testing items, it can not as substituate of each test items.
8 Process Flow Diagram When required as a Quality Plan Submittal, the Process Flow Diagram(PFD) is a graphical block diagram representing the steps material