Bilingual Documentation - Large Hispanic workforce

D

Dan Larsen

#1
I'm working with a client in the states with a rather heavy Hispanic workforce. Apparently the previous MR felt that bilingual documentation would create some kind of control problem. The President of the company asked my opinion.

I suggested that the policy and procedures could probably exist as English language documents, but I saw no reason documents of an instructional nature (at least some of them, depending on the audience) couldn't or shouldn't be bilingual. He mentioned then that the previous MR felt control would be a problem. I told him I didn't think it would be provided he had access to a translator (and he has several qualified bilingual management personnel) to accommodate changes. I also suggested that instructions with less text and more pictures might also be an avenue to explore.

My question: What issues have others run across in applying bilingual documentation? Any particular pitfalls or problems?
 
Elsmar Forum Sponsor
W

WALLACE

#2
Dan,
I have came across this issue a few times and, I have found that it all depends upon the number of users of bilingual documents within an organization, there is the problem of interpretation from one language to another, I had a very intersting experience with a Norwegian organization some years ago, whilst conducting an assessment of the QMS, I noticed that this organization had all documentation available only in english, I was surprised to say the least as, I spoke norwegian quite well at that time and, the reason that I was there was, to be able to respond to the bilingual issues that may come up. I was informed that the organization was advized by the registrar to compile all levels of docs in english as, it was one of the official languages of ISO.
I later found out that this caused some problems with the interpretation of the standard by the employees who were not very fluent with english.
Wallace.
 
L

Laura M

#3
I work at a company with mostly Spanish speaking people. We have the master list reflect whether or not a translated version of the document exists. So far we have translated the quality criteria as they are primarily an inspection service facility.

Other documents I'm finding the folks can read/understand English, just prefer Spanish so we haven't translated. We used training to supplement the English documents. Then the plant manager translates if there are too many questions and we generate the Spanish version.

Small company ~50 people so control has not been an issue as yet.

Laura
 
S
#4
IMO;
Limit your translated documents to as few as possible. Problems exist with proper translation and are compounded with a variety of dialects.
Implement training and pictures/examples. Closer surveillance of new people during their first 60/90 days on the job.

A previous company that I worked for employed hispanic, chinese, vietnamese, korean and one person from indochina; Each with many, many different dialects.
They all preferred to speak their own language. Nightmares!!
 
Thread starter Similar threads Forum Replies Date
S Can medical device labels in EU be bilingual? EU Medical Device Regulations 2
P VDA 2 - Where to find EMPB (Erstmusterpr?fbericht) bilingual forms VDA Standards - Germany's Automotive Standards 2
Q Bilingual ISO 9001 Implementation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
ScottK What is more impressive: Six Sigma Certification or being bilingual Career and Occupation Discussions 16
Q Minimal Documentation Method & 4.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Technical Documentation EU Medical Device Regulations 4
D Swiss Documentation Requirements for Class 1 Medical Device Other Medical Device Related Standards 0
M Should DoC be updated every time Technical Documentation is revised? EU Medical Device Regulations 2
P Controls over Systems Documentation in 21 CFR Part 11 Qualification and Validation (including 21 CFR Part 11) 1
D Does the DoC require a technical documentation version? ISO 13485:2016 - Medical Device Quality Management Systems 1
Y EU MDR Technical Documentation - Defined Review EU Medical Device Regulations 3
P AS9100D clause 8.6 - Documentation required to show evidence of conformity AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
E Discussion: How do you split up your Technical Documentation? EU Medical Device Regulations 4
B Technical Documentation for a medical device accessory Medical Device and FDA Regulations and Standards News 6
I Request for information regarding remote medical monitoring software (its technical documentation and the IUD system) IEC 62304 - Medical Device Software Life Cycle Processes 2
G Technical documentation for UKCA UK Medical Device Regulations 4
xfngrs Multi-lingual documentation IATF 16949 - Automotive Quality Systems Standard 6
R Configuration Management - Identifying Documentation IEC 62304 - Medical Device Software Life Cycle Processes 3
A Technical Documentation => Responsibilities when signing documents ISO 13485:2016 - Medical Device Quality Management Systems 7
A Update of Technical Documentation EU Medical Device Regulations 3
C FDA 510k documentation requirements US Food and Drug Administration (FDA) 1
M Documentation accompanying an aerospace part AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
G Seeking reference guides/ documentation /tips on verification best practices Other Medical Device Related Standards 6
P MDR documentation submissions EU Medical Device Regulations 4
dubrizo Good Documentation Practice (GDP) as it Applies to External Contractors or Vendors Document Control Systems, Procedures, Forms and Templates 4
A Updating Technical Documentation regularly => Leaner Release Advice EU Medical Device Regulations 2
P Updates to Technical Documentation EU Medical Device Regulations 7
R Good Documentation practices SOP US Food and Drug Administration (FDA) 2
S Documents belonging to Technical documentation to be stored in one file or spread in the QM system? EU Medical Device Regulations 10
O MDD 93/42 and making documentation available EU Medical Device Regulations 1
J Advice on documentation for project I am working on... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
H Characteristics related to safety - format of documentation ISO 14971 - Medical Device Risk Management 3
H Do you repeat information throughout your documentation submission? EU Medical Device Regulations 4
J How many hours for a NB to review Technical Documentation? EU Medical Device Regulations 6
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
J Technical Documentation as per MDR / subpoint 6.1 EU Medical Device Regulations 3
B UKRP to what level should you audit Class I Technical Documentation? UK Medical Device Regulations 0
A Technical documentation ce marking pippete tips CE Marking (Conformité Européene) / CB Scheme 0
S Medical Device - Technical Documentation structure EU Medical Device Regulations 1
I "Usability" for technical documentation EU Medical Device Regulations 1
Azaarus Help with CAPA for an IATF finding regarding inspection documentation IATF 16949 - Automotive Quality Systems Standard 10
E Technical documentation for IVDD General/ other CE Marking (Conformité Européene) / CB Scheme 3
B ISO13485 Standard Documentation Packages ISO 13485:2016 - Medical Device Quality Management Systems 2
C Requirement for Revision of Standard in all Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Z Data sheet from McMasterCarr enough for RoHS/REACH documentation? REACH and RoHS Conversations 4
K Addressing Missing Documentation Document Control Systems, Procedures, Forms and Templates 7
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
H MD Technical Documentation and SALES possibility EU Medical Device Regulations 0
A DMDIV-Variants : definition and technical documentation CE Marking (Conformité Européene) / CB Scheme 4

Similar threads

Top Bottom