Key quality assurance processes for medical/pharmaceutical translations

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The medical and pharmaceutical industry’s need for translations is undeniable. Everything from regulatory documentation, patient safety forms, and marketing materials needs translating, and it needs to be done well. Perfectly, actually. Non-compliance with the requirements of the end user (patient, healthcare professional or a regulatory agency) or errors in the text can have devastating consequences. This is where quality assurance steps in – a process specifically designed to find and eliminate errors, inconsistencies, and other problematic features in the translated (sometimes even source) text. The client can thus rest assured the translation is in tip-top shape and ready to be used as-is.

In our experience, which spans over 15 years of translating medical and pharmaceutical texts, the industry allows very little margin for error. Mistakes can be costly at best and fatal at worst, which is why translation quality management is vital. Alamma ensures quality management in two distinct ways:

• corrective actions, the less optimal, but necessary and unavoidable, part of quality assurance
  and
• prevention, aimed at ensuring the required quality of the texts from the get-go.

Corrective actions

Corrective actions are carried out during the translation process and after it. This is a complex and multi-layered process, comprised of several steps.

Firstly, we make sure the translation undergoes careful revision and proofreading. This service is provided by a knowledgeable reviser with extensive linguistic experience in the given field. Each translation goes through five stages of quality assurance. The reviser performs the first three checks in this process:

• Linguistic check: inspects whether the translator has followed all the applicable grammar rules of the target language and thus ensures the translation is grammatically impeccable. This step is, in essence, proofreading the target text.
• Stylistic check: the reviser analyses the style of the source text and determines which stylistic means its writer used to achieve the desired effect. This involves answering the following two questions:
  Which linguistic tools, if any, did the author use to make an impact on the reader?
  Is the text highly factual or is it trying to influence the reader’s opinion?
  Based on these two questions, the reviser makes sure the translation achieves the same effect on the reader and puts the information across in the same manner as the source text. This can only be achieved by using linguistic means that are appropriate for the target language.

• Terminological check: the reviser makes sure the terminology used is suitable for conveying the desired meaning and message, as well as that it reflects the meaning of the source text. The reviser also checks that the translator has used the client’s preferred style and terms.
• Revision check: the translator who prepared the initial translation reviews and implements the reviser’s changes. They have the option to reject any changes that might not be in line with their vision of the translation, ensuring a coherent final product in terms of voice and style. This also gives them a chance to learn from the reviser’s changes and improve their translations in the future. We aim to provide our linguists with regular feedback, and thus the opportunity to grow as language specialists.
• Quality check: (both manual and automated), performed by the project manager. This final stage in the quality assurance process includes checking numbers in the text (i.e., automated comparison of numbers appearing in the source and target documents) and a layout check to ensure source formatting has been retained during the translation process.

These processes ensure that any issues that may have been introduced into the text during the translation process (we are human, after all) are spotted and amended. They also guarantee that the integrity of the translated text in terms of meaning, terminology, style, tone and formatting has been retained.

Preventive actions

Preventive actions are more difficult to pin down as they vary depending on the client and the type and content of the source text. At Alamma, we strongly believe that these preventive actions are non-negotiable and should be diligently implemented with every translation project, as they assure the best possible quality of the translation.

They include:

• Careful choice of experienced and knowledgeable translation teams with suitable formal qualifications. All our translators, revisers, and proofreaders must hold a university degree in translation or an internationally recognised diploma from any other field of expertise, have a minimum of three years’ experience (for general texts) and five years’ experience (for specialist texts) in translation, revision and/or proofreading, have good knowledge of software essential for translation (Computer Assisted Translation tools, MS Office tools), and embody promptness, responsiveness, responsibility, diligence and accuracy.
• Experienced, prevention- and solution-oriented project managers. Members of our team hold a university degree, possess excellent business communication skills in Slovene and English, are proactive, committed and independent, as well as good team players.
• Adherence to reference materials, i.e., glossaries, term bases, existing translations, relevant dictionaries, guidelines, standards, and other materials that may define the appropriate terminology/wording for a particular type of text. You will be able to read more about how we choose reference materials in a future article, so stay tuned!

The translation process is as alive as the language itself. We are all human and mistakes happen, but the processes above are put in place so errors are identified before they get the chance to wreak havoc for everyone involved. Though quality assurance may seem like an objective and measurable multi-step process, it is more often than not an art in itself – a careful act of balancing all translation process stakeholders in an effort to provide a perfect translation.

The question remains: is a perfect translation even possible? If not, what more can we do to get one step closer to this ideal?
We would love to hear your thoughts!