1. Identify variables in a device and how these variables occur in the manufacturing process. 2. Assess the criticality of these variables based on device function and manufacturing capabilities. 3. Plan tests to find the limits of critical variables. 4. Design fixtures and methods to reproduce critical steps of the assembly process. 5. Find solutions to reduce the likelihood of operator related errors. 6. Configure software for the test machines. 7. Organize activities to comply with the intent of regulations and standards. 8. Document results from tests. 9. Imagine new design features and manufacturing concepts to improve manufacturability/efficiency. 10. Communicate and pull in relevant information (either yourself or through another person if language is a barrier). 11. Participate in developing process control strategy.

瑞健集團(SHL)成立於1989年，目標以西方管理模式在亞洲打造具有國際水準的生產中心。如今，在全球製藥及生物科技領域，SHL已成為藥物輸送系統的OEM/ODM領導製造商，如自動安全注射器。除此之外，SHL還擴展許多產品線，像是軟性結構類醫療產品、醫療氣墊床、醫療床、腦神經手術器具、工業 設備和醫療用吊昇設備等，目標市場為北美、歐洲及亞洲。 SHL (Scandinavian Health Ltd) is currently the world's largest privately-owned designer, developer and manufacturer of advanced drug delivery systems. The organization was established in 1989 by Swedish entrepreneurs Roger Samuelsson and Martin Jelf with the goal of combining world-class manufacturing in Asia with the strengths of Western Management practices. SHL manufactures devices including pen injectors, auto injectors and inhaler systems. We also manufacture a range of other products including pressure mattress systems, patient lifting slings, medical soft goods, beds, neurosurgical devices, catheters and industrial equipment.