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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](https://image.slidesharecdn.com/likicrlava2011-111123163257-phpapp01/75/In-country-Review-Underlying-Mines-and-Added-Value-17-2048.jpg)
Uploaded byAlex Lik
In-country Review: Underlying Mines and Added Value
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.
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In-country Review: Underlying Mines and Added Value
- 1. In-Country Review: Underlying Minesand 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: MustHave 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 doit 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
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- 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
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- 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: [email protected] www.a-clid.com