Loc world 2006 10 ocd and foreignexchange

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Translation memory challenges in a compliance environment (Ortho-Clinical Diagnostics and ForeignExchange Translations, June 2006, Localization World Montreal)

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Loc world 2006 10 ocd and foreignexchange

  1. 1. Translation memory challenges in a compliance environment Jim Niziurski, Ortho-Clinical Diagnostics Sonia Monahan, ForeignExchange Translations, Inc.
  2. 2. Agenda <ul><li>Introduction </li></ul><ul><li>Requirements Overview </li></ul><ul><li>Client Case Study </li></ul><ul><ul><li>Customer profile </li></ul></ul><ul><ul><li>Management of linguistic assets </li></ul></ul><ul><ul><li>In-country review requirements </li></ul></ul><ul><ul><li>Performance reporting and certification requirements </li></ul></ul><ul><li>Questions & Answers </li></ul>
  3. 3. 1. Introduction
  4. 4. Introduction <ul><li>Jim Niziurski has worked in the medical diagnostics industry for 25 years. He is a certified Project Management Professional (PMP). His current responsibilities include management of global labeling strategy for Ortho-Clinical Diagnostics (a Johnson & Johnson company). </li></ul><ul><li>Sonia Monahan is a localization industry veteran of 15 years, with an extensive background in medical localization. She is currently Vice President of Operations for ForeignExchange Translations. </li></ul>
  5. 5. 2. Requirements Overview
  6. 6. Requirements <ul><ul><li>Corporate requirements </li></ul></ul><ul><ul><li>FDA regulations </li></ul></ul><ul><ul><li>EU regulations, including: </li></ul></ul><ul><ul><ul><li>IVD Directive (98/79/EC) </li></ul></ul></ul><ul><ul><ul><li>EN 1041 (information provided with medical devices) </li></ul></ul></ul><ul><ul><ul><li>EN 980 (medical device symbols) </li></ul></ul></ul><ul><ul><ul><li>EN 375 (labeling IVDD for professional use) </li></ul></ul></ul><ul><ul><ul><li>EN 376 (labeling IVDD for self-testing) </li></ul></ul></ul><ul><ul><ul><li>ISO 15223 (medical device symbols) </li></ul></ul></ul>
  7. 7. Requirements <ul><ul><li>Control and management of linguistic assets </li></ul></ul><ul><ul><li>Requirements for use of multiple language service providers </li></ul></ul><ul><ul><li>Translation validation and in-country review requirements </li></ul></ul><ul><ul><li>Performance reporting requirements </li></ul></ul><ul><ul><li>Translation certification </li></ul></ul>
  8. 8. 3. Case Study
  9. 9. Linguistic assets <ul><li>Challenge #1 </li></ul><ul><li>Work is divided by language across two suppliers. Consistent TM SOP approach required for both suppliers. </li></ul><ul><li>Solution #1 </li></ul><ul><li>Create joint OCD and supplier translation memory SOP to ensure streamlined sharing and reuse of TM’s. </li></ul><ul><li>Individual language TM’s maintained by supplier who is the owner for that language. </li></ul>
  10. 10. Linguistic assets <ul><li>Challenge #2 </li></ul><ul><li>Changes to both source and translated content must be controlled. </li></ul><ul><li>Changes to English (source) content controlled through OCD’s systems </li></ul><ul><li>Suppliers must provide audit trail for all changes to existing translated segments. </li></ul>
  11. 11. Linguistic assets <ul><li>Solution #2 </li></ul><ul><li>Implement TM SOP. </li></ul><ul><li>Implement process for controlling creation of duplicate translations, when they are required. </li></ul><ul><li>Create custom utilities, allowing leveraging from legacy TM, while highlighting for reviewers changes to 100% matches from the previous version of the same document. </li></ul><ul><li>Audit trail ensures that all changes to 100% matches are reviewed and approved by OCD. </li></ul>
  12. 12. ICR and Validation <ul><li>Challenge #3 </li></ul><ul><li>Audit trail required for all changes to existing translations. </li></ul><ul><li>Need to focus reviewers on identifying errors rather than stylistic changes, and on reviewing only that which has changed since the last approved version. </li></ul><ul><li>Validation of adherence to glossary, boilerplates and style guides. </li></ul>
  13. 13. ICR and Validation <ul><li>Solution #3 </li></ul><ul><li>Utilize automated tools to validate use of glossary translations in target languages. </li></ul><ul><li>Implementation of translation metrics to quantify results (SAE J2450). </li></ul><ul><li>Integration of online terminology management tool, which provides approval and audit trail. </li></ul>
  14. 14. Performance reporting <ul><li>Challenge #4 </li></ul><ul><li>Performance reporting required for pricing, linguistic leveraging, linguistic quality, and on-time deliveries of both ForeignExchange and OCD reviewers. </li></ul><ul><li>Requirement of translation certificates with each project delivery (confirmation that the prescribed translation process was followed). </li></ul>
  15. 15. Performance reporting <ul><li>Solution #4 </li></ul><ul><li>Utilize integrated reporting features of FXTracker to provide ongoing visibility into ForeignExchange performance. Online and customized reporting implemented. </li></ul><ul><li>Translation certification integrated into project requirements and delivery package. </li></ul>
  16. 16. 4. Questions & Answers
  17. 17. Questions? <ul><li>Jim Niziurski </li></ul><ul><li>Ortho-Clinical Diagnostics </li></ul><ul><li>Tel. +1. 585.453.3443 </li></ul><ul><li>jniziurs @ ocdus . jnj .com </li></ul><ul><li>Sonia Monahan </li></ul><ul><li>ForeignExchange Translations, Inc. </li></ul><ul><li>Tel. +1.303.926.7177 ext. 105 </li></ul><ul><li>[email_address] </li></ul>

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