Regulatory Open Forum

Hi Kate.

I am by no means an expert on this topic but I can tell you what I have always done in my career with respect to this and provide my rationale.  I always believe that any time you translate anything from one language to another you should always perform the back or "reverse" translation from the second language back to the first.  Here's why - when you perform the initial translation you sometimes may be "choosing" one option for a term versus another.  When it is reverse translated it will show you if there are holes within the initial translation that might not make sense or worse might be completely wrong.  Additionally, it is also very helpful to have the document translated by one person and the reverse translation done by another so that you can determine if the translation will make sense to other people.  I can provide a real-life example of a situation where we did this (thankfully!) and found that the original translation had no utility whatsoever because the statement made absolutely no sense in context.

We were asked for a document (SDS) to be translated from English to Korean.  OK - not a big deal - plenty of translation houses (especially in the NYC area) who could handle such a translation and all of them very reputable.  Great.  So we send out the document to be translated by one of the translation houses.  They send the document back to us "translated" into Korean.  Great.  No one in my company at the time was able to read Korean so we sent the same document back to the translation house about a week later for "translation" of the document from Korean to English.  This time a second translator did the reverse translation work and sent back the document.  We compared the original document to the reverse translation and found the following sentence in both:

Original - "Keep out of eyes.  If eyes are exposed to product flush with water and seek medical attention" (a very common phrase to be found in SDS documents!)
Reverse translation - "Avoid eyes.  If in eyes use steel wool to remove.  If irritated go to hospital." (not very common as I am sure you would agree!)

When we went back to the translation house with all three documents the answer we received was that there are several meanings to the character (think words here) that was used by the original translator and the document would be considered an accurate translation as well as the reverse translation being accurate because of this multiple meanings situation.  Wow - first we never used that translation house again and second from that day forward I have always done the reverse translation of any document either with different translators or even with different translation houses!

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Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
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Original Message:
Sent: 17-May-2023 18:04
From: Kate Bartelli
Subject: Document Translation

I would like to know if there are actual requirements regarding the translation of processes and documents.

I know that it is recommended to translate to a new language and then translate back to English but I wonder if this or something similar is an official regulatory or ISO requirement.

Thank you 

Kate,

There is ISO 17100 though this is more about translation services and not really about the process itself.  There are some different methods and best practices which can be employed for translation such as just simply using a translation service or application (Google translate - though most will not recommend) or using a professional service with expertise in the documentation being translated.  Typically a best practice is to translate to the target language by one person and then independently back-translate to original language by another person to ensure it is consistent.  But as you can imagine the more robust it is, the more expensive it can be.  It really depends on what you are translating too, internal documentation can be done internal, but say an Instructions for Use probably needs more thorough translation process.  And this process can and does get reviewed by external auditors.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 18-May-2023 09:30
From: Victor Mencarelli
Subject: Document Translation

Hi Kate.

I am by no means an expert on this topic but I can tell you what I have always done in my career with respect to this and provide my rationale.  I always believe that any time you translate anything from one language to another you should always perform the back or "reverse" translation from the second language back to the first.  Here's why - when you perform the initial translation you sometimes may be "choosing" one option for a term versus another.  When it is reverse translated it will show you if there are holes within the initial translation that might not make sense or worse might be completely wrong.  Additionally, it is also very helpful to have the document translated by one person and the reverse translation done by another so that you can determine if the translation will make sense to other people.  I can provide a real-life example of a situation where we did this (thankfully!) and found that the original translation had no utility whatsoever because the statement made absolutely no sense in context.

We were asked for a document (SDS) to be translated from English to Korean.  OK - not a big deal - plenty of translation houses (especially in the NYC area) who could handle such a translation and all of them very reputable.  Great.  So we send out the document to be translated by one of the translation houses.  They send the document back to us "translated" into Korean.  Great.  No one in my company at the time was able to read Korean so we sent the same document back to the translation house about a week later for "translation" of the document from Korean to English.  This time a second translator did the reverse translation work and sent back the document.  We compared the original document to the reverse translation and found the following sentence in both:

Original - "Keep out of eyes.  If eyes are exposed to product flush with water and seek medical attention" (a very common phrase to be found in SDS documents!)
Reverse translation - "Avoid eyes.  If in eyes use steel wool to remove.  If irritated go to hospital." (not very common as I am sure you would agree!)

When we went back to the translation house with all three documents the answer we received was that there are several meanings to the character (think words here) that was used by the original translator and the document would be considered an accurate translation as well as the reverse translation being accurate because of this multiple meanings situation.  Wow - first we never used that translation house again and second from that day forward I have always done the reverse translation of any document either with different translators or even with different translation houses!

------------------------------
Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States

Original Message:
Sent: 17-May-2023 18:04
From: Kate Bartelli
Subject: Document Translation

I would like to know if there are actual requirements regarding the translation of processes and documents.

I know that it is recommended to translate to a new language and then translate back to English but I wonder if this or something similar is an official regulatory or ISO requirement.

Thank you