Controls for Suppliers of Translation Services - Receiving and Verification

[Mark Meer]

Curious how others handle suppliers of translation services.

As far as evaluation/approval, we currently we require ISO 17100 certification, some references, and a supplier agreement.

...but I'm more curious how people handle the receiving/verification side of such services.

For example, suppose you are getting a document translated from English to Italian. Upon receiving the translated document, do you:
a) Trust in the credentials and competence of the translator, and just confirm that everything has been translated?
OR
b) Find a native Italian-speaker to verify the translation.

If (b), then:
- what should their credentials be? Do people hire "lay-person" speakers of various languages to verify documents that are professionally translated?
- what if there is a dispute between the translated document, and a "better" wording suggested by the native speaker?

 

[yodon]

Re: What Controls for Suppliers of Translation Services?

When I've engaged with a translator, I get THEM to do a validation. They use an independent person from the original translator so to me it meets the sniff test.

I'm in the medical device space so it's important that the translator (and the individual validating) has experience translating for medical use.

 

[Mark Meer]

Re: What Controls for Suppliers of Translation Services?

Yes, I'm in medical device space as well... As far as the experience goes, we include that as part of the initial supplier evaluation by way of references or supplier history.

When I've engaged with a translator, I get THEM to do a validation.

Does this get documented? If so, how? A signed declaration?...or is there some established process?

I'd still be curious: what are the qualifications of such a person? Just that they are "independent" (albeit, in your case, part of the same organization)? Are they a "lay person", or a qualified translator specializing in medical translations?

 

[yodon]

Re: What Controls for Suppliers of Translation Services?

Does this get documented? If so, how? A signed declaration?...or is there some established process?

Yes, in a validation report. So, yes, they have an established process for conducting the validation.

I'd still be curious: what are the qualifications of such a person? Just that they are "independent" (albeit, in your case, part of the same organization)? Are they a "lay person", or a qualified translator specializing in medical translations?

The latter (plus independence from the original translator). They provided the qualifications of the translator (mostly just years of experience in the role) in the validation report, as I recall.

 

[Mark Meer]

Re: What Controls for Suppliers of Translation Services?

The latter (plus independence from the original translator). They provided the qualifications of the translator (mostly just years of experience in the role) in the validation report, as I recall.

Interesting. Did you have to specifically request this service? Did it take a lot of shopping around?

I looked through the services offered by a lot of different translation companies, and this is a under-advertised (I don't recall ever seeing it) service, despite its apparent utility.

 

[yodon]

Re: What Controls for Suppliers of Translation Services?

I don't recall exactly how it came about but it was extra $$ on the contract. I've worked with several translators and both offered the service.

 

[EmiliaBedelia]

- what should their credentials be? Do people hire "lay-person" speakers of various languages to verify documents that are professionally translated?
- what if there is a dispute between the translated document, and a "better" wording suggested by the native speaker?

The latter (plus independence from the original translator). They provided the qualifications of the translator (mostly just years of experience in the role) in the validation report, as I recall.

Reviving this thread, as I am struggling to find a good answer to this topic... my company faces this same issue, with "certified" translations provided from our vendor that end up being heavily revised by our our distributors and native-speaking employees. Our translation vendor stands by their work and refuses to make changes to their translations (this is its own issue, I know...). Our internal procedures dictate that the translations must be "certified", but when I've asked what exactly that means, no one has an answer other than "they just have to provide a cert for the translation". So, our internal employees/distributors providing feedback on the official translations is not sufficient because there's no piece of paper attached to it that says they are certified.

My understanding is that there are basically 2 sides to "certified" translation - 1) supplier certification that they are qualified to do the work, ie ISO17100 and 2) a statement for the individual translation that says the translator is qualified to complete the work.

IMO the supplier certification should be part of the purchasing/supplier controls process so some kind of verification of capability should be required up front.

I am fully aware that our vendor sucks and this is probably the biggest issue in this situation, but I am struggling to understand how to incorporate review/revision by our personnel while still documenting a "certificate" for the translation. Is this even necessary if we use a "qualified" supplier? I don't really see any clear-cut requirements in the MDR that point to a requirement for how to execute the translations so I'm wondering if this is even something we need to do, or is it something we can otherwise justify?
Is there an accepted or standardized "validation" process out there that we need to ask for, or is this something we just need to shop around translators for?

 

[yodon]

Unfortunately, I'll lead off with "I don't know" for much of this.

Translation is, in my thinking, just another design output that requires some kind of confirmation. Since it has to meet user needs, I lump this confirmation under validation.

My understanding is that the risk with translations by native speakers is that idioms and possibly slang can creep in whereas the professional translators know to avoid that. Some medical terminology may not be very well translated by native speakers whereas professional translators are supposed to be able to properly translate medical-related information.

I understand the concern about how the employees / distributors want to mold the translations. One thought would be to treat the translations as a formative study. There may well be cases where "formal" translation doesn't work as well as hoped. That will at least give you a paper trail on what was done.

 

[EmiliaBedelia]

Thanks for the input!

With many things, I think the fact that there is no clear answer means it's up to us to come up with a strategy and defend it. I do think that's a great point that this should be considered as a "user need" so that's something I'll definitely have to address.