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Medical Device Vendor (Supplier) Audits - Foreign Languages and Translations

H

HPLC_Help

#1
Hi, everyone -

My company has just completed a vendor audit. The vendor is in Taiwan, and all its SOPs (and most of its documentation) are, as expected, in Chinese.

The vendors told us what the documents are for during the audit, and some of the forms had English translations on them. They also let us take photos of some of the docs. Everything they showed us made sense (that is, documents that we were told were SOPs were formatted like SOPs; docs that were forms looked like forms.)

My question is how far are we expected to go in translating documents. How far have you gone in translating documents?

We were very impressed by the operation, and everything we saw, and what was described to us made sense. But there is always the nagging concern that the actual translation of the documents would be something like, "Only Use This Version When Being Audited by People Who Can't Read Chinese."

Thank you -

H_H
 
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H

HPLC_Help

#3
Re: Vendor Audit - Foreign Language

Thank you, Jim.

Purpose was to qualify a vendor, as per 820.50 "Purchasing Controls." We were evaluating the vendor of a key component of our device. (Which isn't really a device, but that's another story ...)

H_H
 

Jim Wynne

Staff member
Admin
#4
Re: Vendor Audit - Foreign Language

Thank you, Jim.

Purpose was to qualify a vendor, as per 820.50 "Purchasing Controls." We were evaluating the vendor of a key component of our device. (Which isn't really a device, but that's another story ...)

H_H
I just realized that this is a medical device question, and I have no experience in the field, so I'll defer to others here who do have experience. I will say, however, that it's a good idea to get copies of process documents in advance (even if it's just a sampling) especially when the potential supplier is on the other side of the globe.
 
M

MIREGMGR

#5
My question is how far are we expected to go in translating documents. How far have you gone in translating documents?
If you were evaluating (or auditing) a vendor in USA and everything they showed you was in a language you couldn't understand, and they offered you a translation prepared by them but the authoritative documents were the ones in the non-English language, would you consider the evaluation/audit to have been adequate?

My guess is that US FDA's answer to that question, based on "Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements", would be "no", and the answer still would be "no" wherever that vendor happens to be.

Perhaps your overseas audit team could include a team member that speaks/reads the vendor language. Or, that team upon arrival in the vendor-country could temporarily hire and bring along their own technical translator(s).

To answer the original question: the company for which I work would use one of those two approaches.
 
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swathi.sp

Involved In Discussions
#7
Hi all,

We are into radiotherapy and radiology equipment manufacturing in india, and we are looking for medical device language translators.
Please hep us with list of language translators certified with ISO 17001.
 
#8
Hi HPLC_Help,

In short, you need to go far enough that the individual putting their signature on a binding document regarding this supplier can do so confidently and comfortably. One level above that is the comfort level of your organization.

This hits close to home and is relevant. We are a Thai company with most of our SOPs in Thai, a few dual Thai-English SOPs and some purely English SOPs. Our U.S. subsidiary was notified of a CTPAT audit this year and needed to review all related SOPs. Because the English level of the employees actually executing these SOPs was very poor, they were all in Thai, with a couple dual-language.

The concern of our employee in the U.S. was that he was the one signing off on compliance making a personally binding legal commitment to a U.S. federal agency, and if he couldn't review the SOPs personally, he wasn't going to do it.

So we translated all of the SOPs for him. Due to cost concerns, the translations were done in-house (I question the opportunity costs) and were mediocre at best. So now he is stuck in endless Video Conferences with the factory trudging through the SOPs with his questions. Again, a big opportunity cost. Maybe he's being unreasonable but I don't fault him a bit. Also note that we own his company and every problem ultimately comes back to us so there is no incentive for us to behave badly - this is not the case for your situation.

There are a few factors to consider here:

1. Your leverage as a customer to demand dual-language and certified translations.
2. Whether Chinese can be easily translated into English (e.g. Spanish is pretty much word for word accurate while Thai language literal translations produce nonsensical English).
3. Costs. See how much it would cost to have them professionally done. This will certainly benefit your supplier in the long run on international markets.
4. Risks of a bad translation. Certified translations will reduce your personal risk.

I'll say that of all the producers in the region, Taiwan ranks quite high in terms of its reputation for integrity and reliability. It's no Japan, of course, and the judgment needs to be made on an individual basis. Southeast Asian suppliers are hit and miss - we are pretty good because of a 25+ year JV with a Western company with a strong reputation for quality.

Good luck and happy to clarify if I can. :)
 
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