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In-country Review: Underlying Mines and Added Value
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In-country Review: Underlying Mines and Added Value


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  • 1. In-Country Review:Underlying Mines and Added Value by Alex Lik A-CLID
  • 2. Overview2  ‘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 Review4  What  Language Quality Service (LQS)  Marketing Review  Regulatory Review  Product Quality Assurance  Why  Collect Your Arguments (CYA)  Compliance  Local buy-in  Better Product
  • 5. Players5  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: Parties7 PM QARA US QARA EMEA QARA CAPLA Tech Localization Management Team Comm Translation Agency Local Business Units ICR Staff
  • 8. Virtual Team: Must Have8  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. Planning10  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. Axiom12 Theres 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 Wheel15
  • 16. Load your guns16  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 Boss18  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 Value19  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 – Personnel23  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 Criteria24 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. Checklist25  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:  