The Importance of Quality Language Services
High-quality translations in the Medical Device, Pharmaceutical, or Biotech fields are a necessity, not a luxury. These services certainly don’t come cheap, and if you do receive a low-cost proposal, it likely means that some quality processes are being jeopardized in the pursuit of cost reduction. Today, we explore best practices and key procurement considerations when vetting a Language Service Providers (LSP).
What certifications should a provider have? What certifications are available to them?
Certifications (as we know) cost time, money, and resources. When providers hold certifications, it demonstrates that they have a vested interest in quality. There are many unreliable companies penetrating the eMarketplace, this makes evaluating ISO certifications a critical component of any external assessment.
Below are three important ISO standards for a translation company:
- ISO 9001 – General quality management standard that provides requirements for companies to follow regarding quality practices.
- ISO 17100 – Quality standard for translation providers. It’s tailored to translation companies and provides requirements for things like processes, resources, and translator competency requirements. All of which are crucial to quality translations.
- ISO 13485 – Quality standard for businesses that provide medical devices and related services. It extends to suppliers, such as translation companies. In order to get this certification, a translation company must have at least 50% of their business connected to medical devices, If a company has this certification, it shows a huge commitment to the medical device industry.
Questions that help differentiate providers during the RFx process
There are some obvious questions to ask (pricing, payment terms, account management structure, client references, etc.). However, the following are our top 10 questions may help further assist in differentiating the supply base and identifying a strategic partner.
- What is the provider’s capabilities relative to your company’s language requirements/ distribution network? Do they employ in-country reviewers with medical industry background?
- Does the provider have expertise in languages that may be needed in the future?
- Does the provider offer any value-added services that may support/streamline your internal processes and/or generate additional cost savings (i.e. Total Cost of Ownership)?
- Are consulting services offered to support globalization strategy development?
- Does the provider have an experienced team, including project managers, internationalization and localization engineers, medical industry experts, IT and web specialists, multilingual QA testers and proofreaders?
- What is the turnover-rate for provider translators/project managers?
- What are the processes and mechanisms for handling inquiries and reporting problems? How does the provider measure and report client satisfaction? How are satisfaction deficiencies escalated, addressed, and resolved?
- Is the provider using proprietary or public technology?
- Does the provider leverage effective file management, storage and transmission procedures to optimize project management, file transfer, and document archiving?
- Does the provider have the capability to provide needed formats, including eLearning, file types, etc.?
I’m under contract with provider holding all required certifications – Why am I still finding errors?
While there’s no room for error in medical translations, perfection is unrealistic. In order to ensure a seamless, quality-centered, translation process, we recommend the following customer-driven strategies:
- Supplier/Project Management. It’s ultimately the customer’s responsibility to manage the project and allow enough time for a translation provider to produce quality localization content. By clearly articulating expectations, pro-actively communicating inaccuracies with Translation Memory (TM), and coordinating Quarterly Business Reviews (QBRs) to manage and track problems, you can ensure higher-quality translations.
- Insist on CAPA. When errors are found in the review stage of a translation or when something has gone wrong in the project – it is the customer’s duty to demand Corrective and Preventative Action (CAPA). Failing to demand a CAPA eliminates root cause, and provides no assurance that the same issue will not occur again. While this requires not only time, but resource commitment, it’s necessary for effective evaluation.
- Negotiation. Customers should not only negotiate contract rates and fee schedules, but also negotiate defined standards, procedures, service levels, monitoring and continuous improvement processes.
Translations are required during various stages of bringing a drug or medical device to market, including clinical research, regulatory submissions, manufacturing, marketing and packaging. While the direct cost of tactical translation may be small, translation quality can carry substantial liability risks downstream relative to total cost of clinical trials, time to market, the possibility of lawsuits or rejection by regulators, and even the safety and efficacy of the marketed product.