2. Overview
2
‘What”s and “Why”s
Workflow
Virtual team
Underlying mines
Combat engineering
Added value
Take away
3. 3 In-Country Review is…
… critical for regulatory compliance and process reliability. Inaccuracy of
translated materials can put at risk patient or user safety, the company’s
reputation, revenues, and profitability, which can be damaged by a product recall.
Bert Esselink
4. In-Country Review
4
What
Language Quality Service (LQS)
Marketing Review
Regulatory Review
Product Quality Assurance
Why
Collect Your Arguments (CYA)
Compliance
Local buy-in
Better Product
5. Players
5
LBU (ICR)
Marketing
RA
LSP
LM
ISO 13485
EN 15038
Common Sense
6. Translation Effort Necessity Project Plan by LM
Recognized; LM Informed (engage Marketing, RA, and TC)
Plan Kick-off
Translation vendor selected;
What documents and what languages? ICR instructions and personnel lists refreshed;
(Marketing and QA/RA) SLA Verified
Contract + Preps with
Content Ready by TC Translation Package by LM
Translation Agency
Prep
Quote received; PO issued;
instructions given to ICR and translators; Docs to be translated ready Files to be translated are packed and delivered to the
Glossary and TM updated and approved at Draft 1 level translation vendor; ICR standing by
by ICR;
Translation ICR + Draft 2 Final Translation
Make
In-Country Review comments and other feedback
In-Country Review; implemented.
TEP->Test DTP->QA->Final DTP
Content Updates, etc. Content deltas translated.
Final Translation QAed by the agency
Translation Signed Approval and Release Post-Mortem
Release
Parties analyze specific points of success or lack thereof
Updated translation undergoes ICR and Final translation is Approved,
during the project. Particular attention is paid to the TM
last changes if necessary Released, and Archived
changes that are deemed necessary for future activities.
6 Workflow: Stages
7. Workflow: Parties
7
PM QARA US QARA EMEA QARA CAPLA
Tech Localization Management Team
Comm
Translation Agency Local Business Units
ICR Staff
8. Virtual Team: Must Have
8
Players
Knowing who’s on board
Knowing who reports to whom
Communication
Neither lacking
Nor noisy
Scheduling
Differentiatebetween TC and translation
Product allocation plans -> Saving on iterations
12. Axiom
12
There's never enough time and budget to do it properly
but always enough of both to do it again.
(I believe I heard Bernard Aschwanden say that about 3 years ago at STC conference)
13. So, we do it or what?
13
Inaccuracy of translation can
put at risk the company’s
reputation, revenues, and
profitability.
ICR is a major slow-down
factor for TTM, which can put
at risk the company’s
reputation, revenues, and
profitability.
14. 14 Combat Engineering
“In-Country reviews do not have to be onerous if you clearly
define the process and the reviewer’s responsibilities, and if
upper management recognizes the importance of the reviews
and provides the infrastructure to support them.”
“Managing virtual teams”
by M. Katherine Brown, Brenda Huettner, and Char James-Tanny
16. Load your guns
16
Deploy CCMS
Set material delivery mechanism
Give ICRs their toolbox
Explain tasks and checklists
Make sure you’ve been heard
17. Shake your … [beep]
17
Communicate
Establish procedures
Run your virtual team
Get involved in project planning
Communicate
Continuously optimize process
No such months as July and August
Communicate
18. Stir Your Boss
18
Engage upper management
Get buy-in for centralized LM
Make ICR part of job description
Make it to the core team meetings
Communicate
19. Added Value
19
Better TM
Cheaper Localization
Better docs
Happy customer
Better compliance
Happy auditor
Do more in less time
Happy boss
Less recalls
Happy CEO
BETTER PRODUCT
20. Three “eyes”
20
Centralize
Optimize
Training
Communication
Formalize
Team structure
Procedures
Certification
Audits
23. In-Country Review – Personnel
23
Key skills
Native speaker of target language
Adequate language training
Dialect awareness
Fluent in source language
Product knowledge
Target audience knowledge
Team player
Staffing
Assigned by LBU
Approved by RA
Trained and tested by LM
24. Applicability Criteria
24
Document Type Previously Product/Content Translator ICR
Approved
N/A
Instructions for Use
No New
N/A
Same
Existing + new features
New Yes
Same
Existing + new cautions and
warnings New
Yes
Same
No
Existing + minor textual
New
changes/corrections/edits
Same
Yes
Release notes
Items related to safe and
New
effective use of the product
No Same
No items related to safe and
New No
effective use of the product
25. Checklist
25
Know why you are doing this
Have reviewers permanently assigned
Give heads-up as early as possible
Create glossaries and style guides before the translation begins
Communicate early, often, and widely
Document the processes and track review metrics
Establish delivery dates for when reviewers will receive materials for review
Establish deadlines for when the reviewers’ feedback is due
Establish the method in which review comments are captured
Provide specific guidelines for reviewers to follow
Consolidate multiple reviewer comments
Facilitate communication between the translators and in-country reviewers when questions
arise
Put in place a training program for keeping the ICR mechanism greased and warmed-up
Put in place a continuous improvement process specifically for in-country reviews
