The document discusses in-country review (ICR), which involves having native speakers in local markets review translated materials. This is important for regulatory compliance and safety. An effective ICR process requires defining roles and responsibilities, centralizing management of the process, providing proper training and tools to reviewers, and engaging upper management support to prioritize reviews. With the right procedures in place, ICR can add value by improving translation quality and memory, ensuring better product compliance, and allowing more work to be done faster while reducing costs and recalls.

1. In-Country Review:
Underlying Mines and Added Value
by Alex Lik
A-CLID

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

9. 9 Underlying Mines

10. Planning
10
 Translation quality  Product
 Perfect  Stable
 … not perfect  Dynamically changing
 Reviewers  Content delivery
 Trained, dedicated,  Timely
available  Ridiculously late
 Fresh, overloaded, it’s  Content
August  Translation-friendly
 Excuse me?
 Executive
 Buy-in
 Drive-by

11. 11
Biosense Webster Confidential

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

15. Spin the Wheel
15

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

21. Accomplished all that?
21
Get your raise!

22. 22
Take Away

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

26. Thank you!

27. Who is…
27
 Alex Lik
 Interpreter and translator
 Technical communicator
 Editor
 Localization Manager
 Auditor
 A-CLID™
 LSP Assessment and Certification
 Localization Management
 Information Design
 Contact:
 alex@a-clid.com
 www.a-clid.com