Quality Management In Life Sciences Translation


2020-07-02 16:20 Wordbee Translator


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Quality management is a key element of the translation and localization industry. It ensures that the translation keeps the original content and intended purpose. According to ISO 9001:2015, quality is “the degree to which a set of inherent characteristics of an object fulfill requirements.” This means that the translated text must be accurate and error-free, meet the client’s requirements, and fit the purpose and target audience. In Life Sciences, this also means that translators must ensure that the final text complies with strict national and international regulations. Quality is not just the product of a meticulous translation and proofreading process. Rather, it results from a well-designed quality management framework implemented from the very start of the translation project. Quality Assurance vs Quality Control Although often used interchangeably, quality assurance (QA) and quality control (QC) are two separate but complementary components of quality management. QA is a proactive step that sets out the rules and standards to prevent non-conformities, whereas QC is a reactive step aimed at detecting potential non-compliance against these rules and standards. A quality management system that includes systematic QA and QC criteria will result in a final text that meets all linguistic and regulatory requirements. Key Aspects Of Quality Management Translation quality management is based on four key aspects that all language service providers (agencies and freelancers) should observe: 1. ExpertiseThe translator’s expertise is the most important factor in translation quality. Here, qualifications and continuous professional development play a key role, particularly in a field marked by high standards and constant innovation, such as Life Sciences. Apart from language and translation skills, translators must be qualified and understand the subject matter, the purpose, and the target audience. Life Sciences translators may have a background in the Life Sciences field and, later on, specialize in translation, or may be trained in translation and subsequently choose to specialize in Life Sciences. 2. ProcessesTranslation, editing, and proofreading – this is the basic methodology in the translation process. Even the “simplest” text should go through this standard process before being considered final. The translator produces the initial translation; the editor reviews the translated text against the source document; and finally, the proofreader checks the content for formatting, grammar, and punctuation errors. Some projects may require additional steps. For example, in clinical trials, it is recommended to include a back-translation step (translating an existing translation into its original language) for informed consent forms and other documents to ensure that all translations are accurate. 3. Translation TechnologyComputer-assisted translation (CAT) tools have certainly contributed to increasing productivity and quality. The use of translation memories, glossaries, and QA checkers allows translators to produce consistent and accurate texts more efficiently. These tools help to ensure that the whole text is translated in a consistent fashion using the correct terminology. However, without the necessary preparation steps, CAT tools cannot be used to their full extent. Before starting the translation task itself, translation memories should contain all relevant legacy texts, glossaries should list the most appropriate and relevant terms, and the QA/QC criteria should be set from the outset. 4. Workflow AutomationTraditional process management systems are error-prone. Recurrent tasks such as file management, assignment, and versioning control can be performed by a Translation Management System (TMS), allowing translators to focus on the translation task itself. Collaboration and communication features are also important since they allow all those involved in the translation steps to access the project files and specifications. A good TMS is of utmost importance during the preparation phase. Quality And Safety In Life Sciences, quality goes hand-in-hand with safety. When properly implemented from top to bottom in the translation process, a comprehensive quality management system will prevent poor translations that can jeopardize the whole product development process, compromise clinical data interpretation, or cause injury or worse of those involved.
质量管理是翻译和本地化行业的关键要素。它能保证译文传达出原文的内容,达到预期目的。 根据ISO 9001:2015,质量是“某对象的一组固有特性能满足要求的程度”。这意味着翻译文本必须准确无误,既能满足客户的要求,又符合原文目的和目标受众的需求。在生命科学领域中,这也意味着译者必须确保最终译文符合国家和国际的严格规定。 优质译文可不仅是一丝不苟的翻译和校对流程的产物。 相反,从翻译项目一开始,人们就执行着精心设计的质量管理大纲,而优质译文正是由此而来。 质量保证与质量控制 质量保证(QA)和质量控制(QC)这两个概念虽然经常可以互换使用,但它们其实是质量管理中两个独立但互补的组成部分。 QA是主动措施,用于制定规则和标准以防止出现不合格译文,而QC是反应措施,用于检测违反这些规则标准的潜在错误。 一个包含系统性QA和QC标准的质量管理体系所产出的最终译文,能够符合语言和法规方面的所有要求。 质量管理的关键方面 翻译质量管理基于四个关键的方面,所有语言服务提供商(不论是翻译机构还是自由译者)都应遵守: 1.专业水平。译者的专业水平是影响翻译质量的最重要因素。 在这方面,专业资质和专业水平的持续进步发挥着关键作用,尤其是在生命科学这样一个高标准且不断创新的领域。 除了语言和翻译技巧外,译者还必须具备一定的专业素养,比如了解内容主旨、目的和目标受众。生命科学翻译者可能有生命科学领域的学习背景,后来专攻翻译,也可能是受过翻译训练,后来选择了专攻生命科学领域。 2.翻译过程中的基本方法论——翻译处理、编辑和校对。即使是“最简单”的文本,在最终定稿之前,也应该经过这一标准流程。译者产生译文初稿;编辑对照源文档审阅翻译文本;最后,校对人员检查译本的格式、语法和标点符号错误。 有些项目可能需要额外的步骤。例如,在临床试验中,建议对知情同意书和其他文件增加一个回译的步骤(将现有译文翻译成源语言),以确保译文完全准确。 3.翻译技术。计算机辅助翻译(CAT)工具对提高生产率和翻译质量的贡献毋庸置疑。利用翻译记忆库、术语库和QA检查器能使译者更高效地产出连贯而准确的译文。这些工具有助于确保翻译的连贯性和术语的准确性。但是,如果没有进行十分必要的前期准备步骤,CAT工具就无法充分发挥作用。在正式开始翻译任务之前,翻译记忆库应该包含所有相关的遗留文本,术语库里应该列出最恰当的相关术语,并且QA/QC标准应该从一开始就设定好。 4.工作流程自动化。传统的翻译流程管理系统很容易出错。诸如文件管理、任务分配和版本控制之类的重复性工作可以由翻译管理系统(TMS)来执行,从而让翻译人员能专注于翻译任务本身。协作和沟通特性也很重要,因为只有通过沟通协作,所有参与翻译步骤的人才能访问项目文件和规范说明。在项目准备阶段,一个优秀的TMS至关重要。 质量与安全 在生命科学领域中,质量与安全是密切相关的。一个全面的质量管理体系若在翻译过程中自上而下实施得当,可以防止出现劣质翻译,从而防止其危及整个产品开发过程,阻碍临床数据分析,或对有关人员造成伤害甚至更糟的结果。