in-country review: underlying mines and added value
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In-Country Review: Underlying Mines and Added Value
by Alex Lik A-CLID
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Overview 2
‘What”s and “Why”s Workflow Virtual team Underlying mines Combat engineering Added value Take away
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… 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
In-Country Review is… 3
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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
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Players 5
LBU (ICR) Marketing RA LSP LM ISO 13485 EN 15038 Common Sense
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Workflow: Stages 6
Kick-off
Project Plan by LM (engage Marketing, RA, and TC)
Contract + Preps with Translation Agency Content Ready by TC Translation Package by LM
Translation Effort Necessity Recognized; LM Informed
Translation ICR + Draft 2 Final Translation
Translation Signed Approval and Release Post-Mortem
What documents and what languages? (Marketing and QA/RA)
Translation vendor selected; ICR instructions and personnel lists refreshed;
SLA Verified
Quote received; PO issued; instructions given to ICR and translators;Glossary and TM updated and approved
by ICR;
Docs to be translated ready at Draft 1 level
Files to be translated are packed and delivered to the translation vendor; ICR standing by
Updated translation undergoes ICR and last changes if necessary
Final translation is Approved, Released, and Archived
Parties analyze specific points of success or lack thereof during the project. Particular attention is paid to the TM changes that are deemed necessary for future activities.
Plan
Prep
Make
Release
TEP->Test DTP->QA->Final DTP In-Country Review; Content Updates, etc.
In-Country Review comments and other feedback implemented.
Content deltas translated. Final Translation QAed by the agency
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Workflow: Parties 7
QARA US QARA CAPLA QARA EMEA
Localization Management Team
Translation Agency Local Business Units
ICR Staff
Tech
Comm
PM
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Virtual Team: Must Have 8
Players Knowing who’s on board Knowing who reports to whom
Communication Neither lacking Nor noisy
Scheduling Differentiate between TC and translation Product allocation plans -> Saving on iterations
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Underlying Mines 9
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Planning 10
Translation quality Perfect … not perfect
Reviewers Trained, dedicated,
available Fresh, overloaded, it’s
August
Product Stable Dynamically changing
Content delivery Timely Ridiculously late
Content Translation-friendly Excuse me?
Executive Buy-in Drive-by
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Biosense Webster Confidential
11
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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)
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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.
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Combat Engineering 14
“Managing virtual teams” by M. Katherine Brown, Brenda Huettner, and Char James-Tanny
“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.”
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Spin the Wheel 15
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Load your guns 16
Deploy CCMS Set material delivery mechanism Give ICRs their toolbox Explain tasks and checklists Make sure you’ve been heard
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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
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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
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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
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Three “eyes” 20
Centralize Optimize
Training Communication
Formalize Team structure Procedures Certification Audits
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Accomplished all that? 21
Get your raise!
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Take Away
22
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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
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Applicability Criteria 24
Document Type Previously Approved
Product/Content Translator ICR In
stru
ctio
ns fo
r Use
No New N/A
Yes
N/A
Yes
Existing + new features Same New
Existing + new cautions and warnings
Same
New
Existing + minor textual changes/corrections/edits
Same No
New
Yes
Rel
ease
not
es
No
Items related to safe and effective use of the product
Same
New
No items related to safe and effective use of the product
Same
No New
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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
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Thank you!
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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: [email protected] www.a-clid.com