ISO/TS16949內部稽核之製造過程稽核的規劃與實施程序-以某晶圓代工廠為例

Abstract

在邁入21世紀新經濟時代之際，世界各國均將目光焦距於中國大陸的製造業，使得台灣製造業的發展及競爭力面臨空前的挑戰，因此有人主張台灣製造業要競爭的主題應是「Made in Taiwan」與「Made in China」之區隔，強調兩者不同處主要在產品或服務的「品質」。品質是企業生存的關鍵也是客戶滿意的重要指標，提升品質是產品在市場上生存與競爭的最佳策略，台灣的產品若要在國際市場上保有競爭優勢，就需要有一套有效的品質驗證系統。隨著QS-9000於2006年12月失效，ISO/TS16949已成為取得全球汽車供應鏈品質管理系統認證必備的要求。企業通過ISO/TS16949驗證，除可獲得全球汽車零組件產業的商機外，亦可藉由ISO/TS16949品質管理系統的建立，對內可以持續提升其產品與服務品質，對外可以增加顧客的滿意度。

品質稽核是評估品質系統或是監督企業品質體系的有效方法。根據ISO/TS16949：2002條文之要求稽核計劃應含括以下三種型態之稽核：品質管理系統稽核(quality management system audit)、製造過程稽核(manufacturing process audit)，與產品稽核(product audit )。ISO/TS16949品質管理系統重視製造過程的監控與內部稽核規劃，強調缺失的防範，目的是降低汽車零組件生產過程中所産生的品質變異。三種稽核型態中又以製造過程稽核最重要。因此，本研究之主要目的是探討ISO/TS16949品質管理系統中製造過程稽核有關的國際標準，並於訪談專家後，提出一套適用於ISO/TS16949內部稽核之製造過程稽核的規劃與實施程序。本研究最後以新竹科學園區某晶圓代工廠之某一製造過程為案例，實際執行本研究製造過程稽核之規劃與實施設計，驗證了本研究確實有效。本研究所提之方法可提供汽車零組件製造商在申請ISO/TS169494系統驗證時參考之用，使其能迅速正確掌握ISO/TS169494系統中製造過程稽核的重點及精神，進而提升其內部稽核系統之績效。本研究方法不僅適用於汽車供應鏈(Automotive supply chain)之製造商，更是適用於所有欲提升內部稽核系統之製造業，本研究所提之規劃與實施程序可以提升台灣製造業之內部品質稽核系統的績效，進而增強「Made in Taiwan」的產品品質與其在全球市場上的競爭力。

ABSTRACT Companies worldwide are choosing to outsource manufacturing to China. This move has created an unprecedented challenge to Taiwanese manufacturing companies. The difference between “made in China” and “ made in Taiwan” is that the quality of products and services in Taiwan surpass those in China. Quality is central to the survival enterprises, and is the principal index of customer satisfaction. The best strategy for attaining and maintaining competitive advantage is to maximize product and service quality. Taiwanese manufacturing companies require an efficient quality certification system for their products and services to maintain their competitive advantage. As the QS-9000 system was invalidated in December 2006, the ISO/TS16949 system has become the required certification for quality management system in automotive supply chains. This certification promotes the quality of products and services continuously, and enhances customer satisfaction. Manufacturing companies with the ISO/TS16949 certification can acquire business from automotive industries worldwide. The most effective method of quality system evaluation and monitoring is the quality audit. According to IS/TS16949:2002 requirements, internal audits must include the following three audits: quality management system audit; manufacturing process audit; and, product audit. The ISO/TS16949 quality management system is concerned with the monitoring and planning of an internal audit of manufacturing processes, emphasizing failure prevention. The purpose of this audit is to decrease quality variation in manufacturing processes associated with materials and parts manufacturers in the automotive industry. The most important of these three audit types is the manufacturing process audit. This study analyzes international standards associated with the manufacturing process audit in the ISO/TS16949 quality management system. Experts are interviewed to identify appropriate planning and implementation procedures of manufacturing process internal audit for ISO/TS16949. This investigation uses the case study of a foundry wafer plant located in Hsinchu to verify the effectiveness of the planning and implementation procedures for a manufacturing process audit. This study provides a reference for automotive manufacturing companies applying to the ISO/TS16949 system. Moreover, this study improves the performance of the internal audit system. The proposed procedure can be employed to manufacturers in automotive supply chains, and to all manufacturers that seek to improve the performance of their internal audit system for Taiwanese manufacturing companies, to enhance the quality of products made in Taiwan and improve Taiwan’s global competitiveness.