In-Country Review: Underlying Mines and Added Value

by Alex Lik A-CLID

Overview 2

‘What”s and “Why”s Workflow Virtual team Underlying mines Combat engineering Added value Take away

… 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

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

Players 5

LBU (ICR) Marketing RA LSP LM ISO 13485 EN 15038 Common Sense

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

Workflow: Parties 7

QARA US QARA CAPLA QARA EMEA

Localization Management Team

Translation Agency Local Business Units

ICR Staff

Tech

Comm

PM

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

Underlying Mines 9

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

Biosense Webster Confidential

11

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)

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.

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.”

Spin the Wheel 15

Load your guns 16

Deploy CCMS Set material delivery mechanism Give ICRs their toolbox Explain tasks and checklists Make sure you’ve been heard

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

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

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

Three “eyes” 20

Centralize Optimize

Training Communication

Formalize Team structure Procedures Certification Audits

Accomplished all that? 21

Get your raise!

Take Away

22

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

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

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

Thank you!

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