應用失效模式分析方法於製程改善之研究-以S公司線性傳動器為例

Application of FMEA methods in manufacturing process improvement - A Case Study of Linear Actuator

楊獻中(Hsien-Chung Yang)

指導教授 ： 陸元平

國立臺北科技大學/機電學院/機電整合研究所/碩士(2011年)

摘要

面對全球市場競爭劇烈的時代裡，企業不斷降低成本以及增加產品品質的可靠度，來獲得顧客的滿意度已是經營的關鍵因素。產品品質等到顧客從市場反應或是由客訴管道客訴回饋時，都只能靠事後補救的措施，往往不只是金錢方面的損失而已，也會造成企業形象受損、競爭者有機可趁等影響。因此，事前的防範會比事後的補救來得重要，將產品潛在失效問題提前討論，讓失效風險降到最低，以確保產品品質的穩定性，才能具有市場的競爭優勢。
尤其在醫療輔具方面的產品是使用在人員身上，因攸關人員生命安全的考量，是絕不允許產品失效的事件發生，所以產品的設計與製造更需要作事前的失效風險分析與驗證工作。
失效模式與效應分析(Failure Mode and Effects Analysis，FMEA)方法，已廣泛被用在產品設計面與製程面的失效風險評估。FMEA的活動是透企業內部有關單位的專業人員來組成專案小組，對於產品在開發階段針對潛在失效風險進行評估與探討，預估當失效模式發生時的嚴重度、發生度及偵檢度分別給予評價，將風險優先數值經計算後排列出嚴重程度的順序，再針對風險優先數值偏高的部份一一提出改善對策。
對於醫療輔具製程面的失效風險評估探討文獻較少，因此本研究將以S公司所生產的醫療輔具型線性傳動器為例，對產品製程進行失效風險分析，結果發現可以提高產品的製程良率，同時也等於降低重工的時間與作業成本，減少廢棄物產生，也等於減少對環境品質的衝擊，提供產業界參考。

關鍵字

失效模式與效應分析 ； 風險優先數值 ； 線性傳動器

並列摘要

In this day and age to face the highly competitive global market, to the enterprise business it has been a key factor for gaining the customer satisfaction to continuously reduce the cost as well as improve the product quality and reliability. If the quality is relying on the remedies those are coming from the aftermarket response and customer complaint feedback, the losses are not only in the money but also damaged the Corp. image and will be an opportunity for other competitors. Therefore the prevention in advance will more important than the subsequent remedy. To assure the stability of product quality, it should discuss in advance the potential product failures to minimize the risk of failure that will have the competitive advantage in the market.
Especially in the products of the health care assistive device is used for human beings, it is the matter of human life safety that does not allow to happen the product failure incident. So it must need to do the pre-failure risk analysis and verification.
The Failure Mode and Effects Analysis (Failure Mode and Effects Analysis, FMEA) has been widely applied to the failure risk assessment of product design and manufacturing process. FMEA activity is to form a special team by the professionals of related units in the enterprise. This team has to assess and discuss the risk for potential failure in the product development stage, also rate the degree of severity, occurrence and detection when the failure mode occurs. And to calculate the risk priority value and rank the severity list. Then to propose the improvement measures for the higher ranking part of risk priority value in the list.
The FMEA literature for the medical assistive device is quite few. Therefore, this study will be S company produced the linear actuator for Medical assistive device as the example to analyze the failure risk of production process, the result shows that it can improve the production yield by, also it reduce the re-work time, operation cost, waste and the impact of environmental quality that can be provided to the industry for reference.

並列關鍵字

(Failure Mode and Effects Analysis, FMEA) ； (Risk Priority Number, RPN) ； Linear Actuator

參考文獻

[2] 楊憲忠，利用FMEA於新設產線工程招標選商最佳化決策模式之研究，碩士論文，國立屏東科技大學企業管理研究所，屏東，2008。

[15] 許芳勳、彭鴻霖，「失效模式、效應與關鍵性分析結果之應用」，中華民國第二屆可靠度與維護度技術研討會論文集，1997，第169-174頁。

[24] 莊寶鵰、張添盛、黃仕慶等，電子組裝製程失效模式與效應分析之討，中華民國品質學會，第38屆年會暨第8屆全國品質管理研討會。

[9] 黃加昌，創新研發管理之前端預防設計資訊系統建置－以自行車產業為例，碩士論文，國立台北科技大學工業工程與管理研究所，台北，2010。

[20] 正緯顧問，FMEA失效模式與效應分析，訓練教材，正緯管理顧問股份有限公司，2005。