Method of managing error risk in language translation
Methods for analyzing, evaluating, and controlling risk of errors in language translation of medical device labeling are disclosed. The disclosed methods include identifying the risk level of the device; identifying the safety function(s) of the content that is translated; evaluating risks associated with the translation process; and analyzing this risk information and applying it in the selection of resources and in the design and execution of processes, to effectively mitigate the risk of safety related translation errors in labeling for medical devices.
1. A system for preparing a translation of a labeling document from a source to at least one target language, the system comprising:
a medical device having a quantifiable risk classification;
a medical device labeling document in the source language, the labeling document having an intended use in connection with the medical device and being translated from the source language to the at least one target language; and
a risk calculator for assessing the translated labeling document for potential risk to a human from use of the medical device as a function of:
the medical device risk classification,
the intended use of the labeling document in the at least one target language,
the source language, and
the at least one target language,
wherein the risk calculator requires additional translation efforts when the assessed potential risk exceeds a risk threshold.
2. The system of claim 1 , wherein the device classification is on a numerical scale from 1 to 3 progressing from lowest risk at 1 to highest risk at 3.
3. The system of claim 1 , wherein said medical device is one used in medical applications on human patients.
4. The system of claim 1 , wherein said document identification means includes means for identifying the document type from a list comprising documents relating to training, instruction, marketing, Web site, adverse event reporting, recalls, or regulatory submission.
5. The system of claim 1 , wherein said assessment-providing device is adapted to provide said assessment as a function of language hazards.
6. The system of claim 5 , wherein said assessment-providing device is adapted to provide said assessment as a function of language and language character sets between the source language and at least one target language.
7. The system of claim 1 further including means for back-editing the translation document to review the translation using a translator whose native language is the source language.
8. The system of claim 1 , wherein said assessment-providing device is adapted to provide said assessment as a function of a potential for serious consumer harm using a database having a table of error seriousness applied to the back-edition.
9. The system of claim 1 further comprising means for reviewing translation from the source language to at least one target language pertinent to the medical device as a function of the assessment relating to the translation from the source language to the at least one target language.
10. The system of claim 1 , wherein said means for accessing and said means for identifying include a database containing a table of pro-forma risk management plans for similar documents and similar device classification.
11. The system of claim 1 further including a database the list of translation vendors for performing the translation, wherein performance of each translation vendor is rated as a function of the number of translation errors in prior translations and as a function of error seriousness.
12. The system of claim 11 , wherein the rating is by document type.