隨著全球醫療器材產業以及藥物傳輸系統技術的蓬勃發展，產品需求預測提升。為了滿足客戶訂單與配合客戶設計製造之需求，企業規模不斷地成長，卻也帶來一連串的挑戰，客戶的要求越來越嚴苛，產品趨向少量多樣，產品上市時程縮短，時間與效率逐漸成為企業保持競爭力的關鍵。 精實六標準差結合精實生產與六標準差的優點，具有減少浪費、加速流程、降低流程變異的功能，廣泛應用於製造業，是一套熱門的管理方法。本研究便以導入精實六標準差於個案S公司，運用DMAIC的手法配合精實生產的精神，探討現有流程可能存在的缺失。改善的焦點在首件前置作業流程，目的是要提升首件成功率進而改善生產績效。研究中發現工程師為首件前置作業的關鍵影響因素，是改善的主要標的；經過改善團隊重新規劃流程，利用標準化的作業程序，並提出一套在職訓練與資格認證的方案執行之後，一次首件成功率從75.10%提昇至86.15%，改善11.5%，平均首件花費時間減少2.32小時，改善率59.79%，結果顯示運用精實六標準差提升生產績效具有顯著之成效。 / The rapid growth of global medical device industry and technology of drug delivery system accompany with the increment of demand forecast. In order to fulfill the customer orders and requirements, the scale of the enterprise keeps growing and brings a serious of challenges: the higher level of customer requirements, the growing trend of small- volume- large- variety production, shortened time-to–market schedule. Time and efficiency have gradually become essential for the enterprise to retain competitive. Lean Six Sigma combines the advantages of lean production and six sigma, it can reduce the waste and speed up the process as well as decrease the process variation through statistical approach, which is a popular management methodology and widely applied in manufacturing industry. The purpose of this study is to introduce Lean Six Sigma (LSS) to S company, trying to find the potential failure in current process via DMAIC steps and lean thinking. The improvement is focus on operation before first article pass, project goal is to increase first article pass rate. We find the engineer is key input variable during the process. After reorganized the process flow and implemented new On-Job Training (OJT) and qualification programs, the study result shown that first article pass rate has increased from 75.10% to 86.15%, the improve rate is 11.5%; the average waste time of first article has reduced 2.32 hours, the improvement rate is 59.79%. We can conclude that there is a significant improvement on production performance by applying Lean Six Sigma