全球化年代，我們一起經歷新冠(COVID-19)抗疫，也共同關注烏俄大戰。有一種物質卻連結了彼此；在救人的手術房內，醫療器材需要用它來滅菌，降低感染風險，但在殺人的戰場上，真空彈卻靠它填充，才能增加爆炸範圍與提高燃燒溫度。它，就是「環氧乙烷」。
個案以大瓏企業投資興建新世代環氧乙烷滅菌廠為背景，描述企業面對陌生物質與經驗困境時，如何於建廠規劃階段，參考安全管理系統之架構，開始設立目標，籌組團隊，執行危害識別與分析，落實風險評估與控制作業，最終從人員、建築、系統、原料與環境領域架構出多層保障，完成任務的過程。
主要透過經理人實際可行的視角，在確認危害物質特性及法規符合性並運用採購策略限制風險範圍後，再聚焦探索工業安全相關理論對於危害物質運作風險評估與控制領域所帶來的價值，以確保「人員安全第一，損壞範圍可控」的安全目標。包括增加多層防護的瑞士乳酪理論架構，透過 FMEA 進行系統與環境的失效風險評估，以及運用屏障理論設計多道阻隔與控制損害範圍。最後，整合企業文化後加入安全文化，藉強化溝通、長期培養與建立共識，奠基為後續推行滅菌廠的安全保證與永續發展之目標。

In the new era of globalization, we have experienced the fight against COVID-19 together and concerned about the Ukrainian-Russian war. There is one hazardous substance that connects both events. The medical devices used in the operating room for saving lives must be sterilized with it to reduce the risk of infection. The vacuum bombs that are used in the battlefield also rely on it to increase the explosion range and combustion temperature. That is the "Ethylene Oxide", also known as EO.
This case is based on NewDeantronics’s investment in the constructing a new generation of EO sterilization facility in Taiwan. It describes how the company without previous experience for dealing with hazardous substances, began to set goals and form a team to run Safety Management System (SMS) at the planning stage for the construction of EO facility, in order words hazard identification and analysis, risk assessment and risk control, finalized with the constructing of multilayer protection from the fields of personnel, buildings, systems, raw materials and, the environment.
After identifying the characteristics of hazardous substances and compliance with regulations, setting procurement strategies to limit the scope of risks, the company started the risk assessment and risk control process to achieve the goal of "Personnel Safety Comes First and Controllable Damaged Scope". This case adopted the framework of Swiss Cheese to propose multilayer protection, the failure risk assessment of the system and environment through FMEA, and the Barrier Theory to design multiple barriers and control the scope of damage. Lastly, the safety culture was incorporated by strengthening communication, continuous training to reach consensus for achieving safety assurance and sustainable development of the EO sterilization facility.

一. 中文部分
1. 詹明錦、張靜美、王甯祺、邱勝康和張峰義(2010)。滅菌起源與生物指示劑的發展。感染控制雜誌，Page.395-405。
2. 彭舒平、胥樹萍(2009)。環氧乙烷滅菌器的臨床應用探討。中國誤診學雜誌， Page.5881-5882，9 卷，24 期。
3. 王心靈(2012)。飛航安全管理系統-以美國飛航安全管理系統 AC120-92A 為例。
4. 于樹偉、林明洲、翁德宗、劉秋萍(2001)。風險評估技術指引。風險評估技術手冊，第一版。
5. 曾嶔元(2014)。風險管理概論。生物醫學期刊，Page.158-163，7 卷，3期。
6. 蕭景祥、李金泉、魏榮男、鄭世岳(2021)。危害認知。職業衛生概論，,第四版。
7. 蔡衍真(2018)。工業安全管理觀念的演進與典範轉移。工業安全衛生月刊，Page.19-46。
8. 曹常成、洪銀忠(2009)。風險評估在石化業安全衛生管理之角色與功能。行政院勞工委員會勞工安全衛生研究所。
9. 楊順天(2015)。應用 FMEA 與 FTA 於超高壓電纜製程之研究。
10. 郭俊彥(2019)。結合 FMEA 和 FTA 應用於廢水處理系統失效風險評估之研究。
11. 任義明(2020)。國道養護工作場所安全檢查與風險評估。
12. 潘志明(2017)。化工製程半量化法製程危害評估。
13. 金德(2021)。如何提升公司安全文化。工業安全衛生月刊。
二. 英文部分
1. The American Chemistry Council’s Ethylene Oxide/Ethylene Glycols Panel (2007.5), Ethylene Oxide Product Stewardship Guidance Manual, third edition, Chapter 5.0
2. Aven, T. (2016). Risk assessment and risk management:Review of recent advances on their foundation. European Journal of Operational Research, 253(1), 1-13.
3. Fukuoka, K. (2016).Visualization of a hole and accident preventive measures based on the Swiss cheese model developed by risk management and process approach. WMU Journal of Maritime Affairs, 15(1), 127-142.
4. Haddon, W. (1963). A note concerning accident theory and research with special reference to motor vehicle accidents. Annals of the New York Academy of Science 107, 635-646.
5. Cox, S. & Cox, T. (1991)The structure of employee attitudes to safety: A European example Work and Stress, 5, 93-106.
三. 網路部分
1. 烏控俄用「真空彈」 軍事專家:無差別衝擊恐傷及平民(發布日期:3.1.2022)
https://tw.news.yahoo.com/%E7%83%8F%E6%8E%A7%E4%BF%84%E7%94%A8-E7%9C%9F%E7%A9%BA%E5%BD%88-%E8%BB%8D%E4%BA%8B%E5%B0%88%E5%AE%B6-%E7%84%A1%E5%B7%AE%E
5%88%A5%E8%A1%9D%E6%93%8A%E6%81%90%E5%82%B7%E5%8F%8A%E5%B9%B3%E6%B0%91-095932440.html
2. CSB Safety Video: Ethylene Oxide Explosion(出版日期:3.6.2007)
https://www.youtube.com/watch?v=_2UnKLm2Eag
3. FDA: Why Is Ethylene Oxide Used to Sterilize Medical Devices?( datePublished: 2022-02-17)
https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxide-sterilization-medical-devices
4. 醫材廠大火急撤易爆鋼瓶(發布日期:7.15.2015)
https://news.ltn.com.tw/news/society/paper/898008
5. 勞動部勞動及職業案全衛生研究所:被刺破的環氧乙烷桶爆炸(發布日
期：2.21.2008)
https://www.ilosh.gov.tw/menu/1169/1172/%E6%90%AC%E9%81%8B%E6%98%93%E7%87%83%E7%89%A9%E7%9A%84%E8%BB%8A%E8%BC%9B%E8%AB%8B%E5%8A%A0%E8%A3%9D%E6%BB%85%E7%84%B0%E5%99%A8/
6. 中國安全生產協會:環氧乙烷鋼瓶汙染聚合爆炸(发布日期：11.24.2018)
https://www.china-safety.org.cn/Article/Detail_1796_36_143_8_206.html
7. U.S. Chemical Safety Board(CSB):Sterigenics Ethylene Oxide Explosion(發布日期:3.30.2006)
https://www.csb.gov/sterigenics-ethylene-oxide-explosion/
8. 蘇貞昌舉「乳酪理論」導致停電挨批 | NOWnews 今日新聞 | LINE TODAY(發布日期:3.29.2022)
https://today.line.me/tw/v2/article/JPXromM?utm_source=lineshare
9. 維基百科:瑞士奶酪理論(最後修訂日期:11.4.2021)
https://zh.wikipedia.org/wiki/%E7%91%9E%E5%A3%AB%E5%A5%B6%E9%85%AA%E7%90%86%E8%AE%BA
10. Wikipedia:Swiss Cheese Model (Last edited on 25 April 2022)
https://en.wikipedia.org/wiki/Swiss_cheese_model
11. 維基百科: 失效模式與影響分析(最後修訂日期:9.3.2021)
https://zh.wikipedia.org/wiki/%E5%A4%B1%E6%95%88%E6%A8%A1%E5%BC%8F%E4%B8%8E%E5%BD%B1%E5%93%8D%E5%88%86%E6%9E%90
12. Wikipedia:Safety culture (Last edited on 26 November 2021)
https://en.wikipedia.org/wiki/Safety_culture
13. 百度百科:安全文化(最後修訂日期:11.19.2021)
https://baike.baidu.hk/item/%E5%AE%89%E5%85%A8%E6%96%87%E5%8C%96/7266464
14. Wikipedia:Organizational_safety (Last edited on 9 March 2022)
https://en.wikipedia.org/wiki/Organizational_safety