| 摘要: | 隨著科技進步與智能傳感技術日臻完善。現今，市面上湧現出大量智能穿戴式醫療
產品，並且改變了傳統產品的功能與型態。然而，目前市場上的智能穿戴式產品種類繁
雜，品質參差不一。企業為了縮短產品開發週期，模仿風氣日益濃烈，而無法把關產品
的品質管理的重心，使人們的健康安全帶來諸多隱患。尤其是面對現今高齡化社會進程
的加速、慢性病低齡化，健康逐漸成為社會關注的焦點之下。為了提醒用戶自主健康管
理，並採取預防措施，為使用者準確地提供個性化的醫療保健以及診斷治療信息。在這
一背景下，智能可穿戴式醫療產品的品質管理扮演舉足輕重的地位。
因此，本研究以智能手錶為例，圍繞其新產品開發專案中的品質管理進行研究。運
用兩種品質管理工具在品質機能展開(Quality Function Deployment，QFD)與失效模式與
效應分析(Failure Mode and Effect Analysis，FMEA)整合性使用到產品的品質管理中。力
求從客戶的角度出發，改善產品適用性，保證最終產品品質。在實證分析中，首先利用
問卷調查法確定客戶需求，使用層次分析法(Analytic Hierarchy Process，AHP)透過專家
打分，並根據客戶需求分析出各組件的重要度。同時，建立智能手錶的品質屋(House of
Quality，HOQ) ，計算出各項改進措施與技術特性權重度。最後，根據前部分的研究基
礎上，列舉所有的關鍵失效模式，分析產品失效的潛在故障，得出各個風險因素的嚴重
度、發生度、偵測度，通過對此三個因素進行風險優先指數(RPN)的計算。此外，將會針
對風險水平超過標準值的部分實施改善措施，提升產品品質可靠度。;At present, smart wearable products on the market have a wide variety of products with
varying quality. In order to shorten the product development cycle, the imitation trend is
becoming increasingly strong, and the company cannot control the focus of product quality
management, which brings many hidden dangers to people′s health and safety. Especially in the
face of the acceleration of the current aging society and the younger age of chronic diseases,
health has gradually become the focus of social attention. In order to remind users of
independent health management, and take preventive measures, to provide users with
personalized medical care and diagnosis and treatment information accurately. In this context,
the quality management of smart wearable medical products plays an important role.
Therefore, this research takes smart watches as an example, and conducts research on
quality management in its new product development projects. Use two quality management
tools to integrate quality function deployment (QFD) and failure mode and effect analysis
(FMEA) into product quality management. Strive to improve product applicability from the
perspective of customers and ensure the quality of final products. In the empirical analysis, first
use questionnaire survey to determine customer needs, use Analytic Hierarchy Process (AHP)
to score points through experts, and analyze the importance of each component according to
customer needs. At the same time, a house of quality (HOQ) of smart watches was established,
and various improvement measures and the weight of technical characteristics were calculated.
Finally, based on the research in the previous part, enumerate all the key failure modes, analyze
the potential failures of product failure, and obtain the severity, occurrence, and detection of
each risk factor, and use the risk priority index for these three factors. (RPN) calculation. In
addition, improvement measures will be implemented to improve product quality reliability in
areas where the risk level exceeds the standard value. |
