【云南】罗氏制药技术操作部门中英文专题配音文案_解说词

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Hello. My name is Yavuz Goktas.

I am part of the Business Process Excellence Group and also the lead for development and deployment of a harmonized and robust root cause methodology for Pharma Technical Operations at Roche.

I’d like to take a moment to thank you for joining us in this journey through Root Cause Analysis, or “RCA”. 

You might be familiar with the term “Root Cause Analysis” from your work within Pharma Technical Operations. You may have even performed an RCA using some RCA tools or some other quality investigation methods. Our purpose today is to expand on what you have done so far and standardize and strengthen your knowledge of RCA. 

In this course, you’ll receive an introduction to our new, more robust and harmonized RCA methodology called the 7-Step RCA Methodology. You’ll gain an awareness of how this methodology will work for you and see an overview of the steps, tools, and most importantly, the statistical analyses that make the 7 steps so important to conducting an RCA in PT. Also, you’ll see how the benefits of speaking the same “RCA language” can strengthen our company as a whole. 

In PT, our highest priority is engraining quality in everything we do. This begins with our internal processes and strategies. You’ll see that our definition of RCA specifies a standardized, structured approach that is aligned with our GSPs associated with discrepancy management. It provides a level of rigor and documentation that ensures solutions are verified and validated with facts and data. You’ll see how the sustainment and ongoing evaluation of solutions is an integral part of our process. 

We now have a systematic, standardized and robust way of doing RCA across PT. 

So, let’s get started. Enjoy the ride!

您好，我的名字是 Yavuz Goktas。

我是业务流程卓越团队的成员，是为罗氏制药技术操作部门开发和部署一套统一且稳健的根本原因方法的负责人。

我想借此机会感谢您加入我们的根本原因分析或 "RCA" 之旅。

您可能已经从制药技术操作工作中熟悉了“根本原因分析”一词。您甚至可能已经使用某些 RCA 工具或一些其他质量调查方法进行了 RCA。今天，我们的目的旨在扩大您目前的工作范围并规范和巩固您的 RCA 知识。

在本课程中，您将了解更稳健、统一的新 RCA 方法（名为 7 步 RCA 方法）。您将了解此方法如何为您工作以及有关步骤和工具的概述，*重要的是了解统计分析，这些分析使 7 个步骤对执行 PT RCA 极为重要。此外，您还会了解使用同一种“RCA 语言”的好处如何增强公司的整体实力。

在 PT 中，我们的*高优先事项是在我们的所有工作中树立质量标准。这始于我们的内部流程和策略。您将了解到 RCA 定义指定了一种标准化、结构化的方法，此方法与差异管理相关性 GSP 保持一致。它提供了严谨性水平和确保通过事实和数据核实和验证解决方案的文档。您将了解解决方案的支持和持续评估如何成为流程中不可分割的一部分。

我们现在有一套系统化、标准化和稳健的方法来执行 PT RCA。

所以，让我们开始吧。享受旅程！

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