Perils of Translation Quality Validation in International Labeling. By Sonia Monahan

Transcription

1 Perils of Translation Quality Validation in International Labeling By Sonia Monahan 12

2 Every single day, another international labeling project is set up with its highest element of risk directly at the end of the project. Quality validation is hugely important; that goes without saying, especially in regulated industries. But even from a purely practical project management perspective, allowing the largest element of risk to fall at the end of the project timeline would be absolutely unacceptable in almost all other circumstances. ForeignExchange Translations, a language services provider focused on serving medical device, biomedical and pharmaceutical companies, recently performed a linguistic quality survey targeting respondents from the medical device industry, translation service providers and professional language translators. When they were asked, What is your biggest translation challenge? their number one answer was in-country review. The top answer to How is quality measured? was, ironically, in-country review feedback. It is surprising that the international labeling development process continues to rely so heavily on in-country review for quality validation. To get a sense of the risk it presents, consider a typical five-language release (a small project by medical device standards) of instructions for use labels, which will often bring together up to 29 professionals all focused on one goal: multi-language release of international labeling documentation (see Figure 1). The risk of delay is very real: one person, in one language, can bring a five-language project to a complete halt, effectively discounting the efforts of 28 other professionals who completed their tasks in a timely fashion. Many companies in regulated industries cannot ship product until the documentation is completed in all required languages. Consider that this example is small in scale, as many medical device companies release their products in 15 to 30 languages, exponentially increasing the risk of delay. Challenges of the In-country Review Process Quality The objective of quality validation is typically to confirm technical accuracy of the translations, consistency with brand messaging and accuracy of company standard terminology. However, personal preferences often dictate the process, making editorial and stylistic changes a common theme. Most reviewers are not professional linguists. Worse, inconsistencies are often introduced during this quality validation step because reviewers are not familiar with previous translations or agreed-upon company standard terminology. Additional quality issues surface when the main reviewer is out of the office and the person covering is not familiar with the Figure 1. Typical Resources for International Labeling Projects Language Services Company Account manager 1 Project manager 1 Technical lead 1 Resource manager 1 Professional translator (all languages) 5 Professional editor (all languages) 5 Professional proofreader (all languages) 5 Graphic designer 1 In-country reviewer (all languages) 5 Professional QA staff 1 Medical Device Company Technical writer 1 Manager 1 Graphic designer 1 in-country task process or terminology glossaries or stylistic conventions (see Figure 2). Turnaround time Product marketing personnel or distributors in-country are likely candidates for performing the task of review. They are often knowledgeable about products and technical issues but reviewing the written word, whether on labeling, marketing materials or software strings, is typically not their job. Therefore, the task is usually done in any spare time they may have. Some in-country reviewers do turn their work in on time, but others may take months to complete a review. Product releases can be held up based on these review delays or further errors introduced into the translations (see Figure 3). Cost If the documentation release is late because of the issues mentioned above, the product launch could be delayed, which means a large-scale impact on cost. If errors are introduced into the translations at the quality validation stage, companies will need to pay more money to fix these errors. If the errors remain undetected until after product launch, it will cost even more money to redo and reprint international labels. It is important to recognize that properly setting up a standard, in-country review process to validate the quality of your international labeling will contribute to its success. There are companies that do have success using in-country review for quality validation. Following are some best practices that will increase the likelihood of achieving your project goals and meeting your project timelines. Regulatory Focus 13

3 Figure 2 Standard In-country Review Companies should identify objectives of the review and expectations for the reviewers, including expected turnaround times. Discuss these expectations and gain agreement from the reviewers. Also, take the time to train the reviewers regarding how the review process will be conducted, the tools used during the process and primary communication mechanisms. Be prepared to identify primary and back-up reviewers for each language. Implement a standard terminology glossary and style guide and make sure they are kept current and periodically reviewed by the in-country review team. At the start of any translation project, provide anticipated dates and the scope of work to the reviewers and identify any conflicts (vacations, travel dates, meetings) that would require the back-up reviewer to be used. Once the reviews are completed, evaluate the changes from the reviewer against the glossary, style guide and specifications. Categorize the changes by error type, noting also stylistic and preferential changes made. Provide feedback to the reviewers on quality of the changes, noting also where they have introduced errors. The objective is continuous improvement of quality (see Figure 4). Even with all of these items completed, in-country review remains a challenge. Delay from one reviewer can potentially stop a product launch. What are some viable alternatives then to allow a product release to go on schedule? Alternatives for Quality Validation One option to address turnaround time challenges is to assume if the review is not received by the agreed upon delivery date, the document is approved with no changes. While we have seen a few clients adopt this approach, it may not stand up to an audit because no actual validation has been done. Back Translation Back translation is the process of translating back into the source language. This allows validation of the translation by a non-native speaker (a native speaker of the source language can do this validation). It is probably most appropriate for small documents, since it is very time-consuming and expensive to complete the back translation and to review and resolve discrepancies. Sampling By utilizing data on quality, a number of our clients have been able to switch to reviewing only a subset or sampling of the translations. In this 14

4 Figure 3 Figure 4 16

5 scenario, if a project consists of only updates to existing products (meaning no new terminology), in-country review is eliminated from the process. If projects are over a certain size and are new, only 10% of the projects are reviewed in-country and the translators apply the terminology or stylistic changes to the remainder of the translations. Third-party Review This step consists of a comprehensive review of the translation against the source text by subject matter experts with an eye toward technical accuracy, as well as adherence to glossaries and style guides. Reviewers are evaluated in terms of specific scientific or medical experience, as well as linguistic expertise. The key advantage to this approach is the consistency of turnaround time and, ultimately, the quality received. Because these reviewers are paid for this task, they are held accountable to delivering to the specific deadline and task specifications. Measured Quality Quality validation of international labeling at the end of the process is clearly a high-risk proposition. If quality could be validated throughout the project s lifecycle from start to finish it would be possible to build quality into the DNA of every project at several stages, not simply check it at the end. This approach reduces the risk, will ultimately reduce the volume of work that needs review, and may eventually eliminate the need for quality validation at the end of the process, since validation has been performed all along the way. But, there are significant obstacles to the whole idea of implementing quality throughout the process that prevent its active pursuit in today s world. It is too expensive. It slows down delivery. To increase quality, additional process steps are needed, i.e., more in-country review, more editing, more proofreading, etc. The value of adding steps is questionable. Comparisons of edited and proofed files against original translations often show additional editors and proofers actually detract from quality as much as they improve it. In traditional processes, none of these numerous steps captures the translation quality level desired. What is needed is a paradigm shift that can change the way localization projects are managed. METRiQ, a quality measurement methodology, can be used to increase quality and drive efficiency improvement. The challenge is to measure in the most objective manner possible, though translation quality will always retain a subjective aspect. When integrated into a translation quality system, measurable quality methodologies like METRiQ can dramatically improve results. Delivered quality can be increased and project costs and turnaround times reduced. Again, the typical approach to delivering translation quality has been to add steps. In the absence of an accurate measurement, language service providers and the clients they serve have approached this problem by adding manual quality assurance (QA) steps, as well as automated QAs, end-client review cycles and more. The assumption is the more people who review the translation, the better it will be. On the contrary: involving more people increases the possibility these QA resources may have less knowledge of the linguistic requirements for that particular project or product and may, in fact, add errors. But, if you can identify problem areas early in the project lifecycle with a methodology like METRiQ, which provides a framework to easily and accurately determine benchmarks for improvement, then you can implement changes early in the process reducing risk of project delay and increasing project quality early on. The cost-time-quality trinity can coexist through smart implementation of a measured QA program. Measured quality methodologies permit focused, surgical improvements rather than siege-style QA processes. By measuring the quality of your translations, you set the bar to the high standard you want and hold it there. And quality validation is no longer that black box at the end of a process. Author Sonia Monahan is a Six Sigma Black Belt and a 17-year localization industry veteran with an extensive background in the medical sector. Sonia holds a Masters in education from Lesley College. For more information on measured quality, contact Sonia Monahan at smonahan@fxtrans.com. Regulatory Focus 17