1. June 16 | LEO Pharma research based, people driven RIGHT-FIRST-TIME PROJECT Topicals Bulk Business Unit LEO Pharma Marie Hayes OpEx Department

2. June 16 | Slide 2research based, people driven OVERVIEW PROJECT BACKGROUND GOALS - Deliverables METHODS – DMAIC model, Error-proofing ACTIONS – Data-gathering, Analysis RESULTS – Implementing findings LEARNINGS – What went well?, What can we build on?

3. June 16 | Slide 3research based, people driven BACKGROUND January 2009, a Value Stream Mapping exercise was carried out, to identify areas to focus our improvement activities 43 key priorities were identified and prioritised Error Reduction in Batch-Paperwork was identified as a key priority Project Scope: Dovobet ointment

4. June 16 | Slide 4research based, people driven METHODOLOGY 5. CONTROL 4. IMPROVE 3. ANALYSE 2. MEASURE 1. DEFINE The DMAIC Cycle SIPOC Process Map Gather data Pareto, Bar chart Root Cause Analysis Plan and implement actions to improve Sustaining the gains Close out Actions

5. June 16 | Slide 5research based, people driven ERROR-PROOFING METHODS Error-Proofing: The process of anticipating, preventing, & detecting errors which adversely affect customers & result in waste – developed by Shigeo Shingo - 950’s Error Analysis, Deviation Analysis & Error Elimination Error-proofing Documentation – Affordance Techniques: Simplify, Use Colours, Photographs, Symbols, Process Flow Diagrams, reminders, prompts, accurate work-flow Error-proof Processes – install fail-safe devices so that the system user cannot overlook the required detail Standardisation and Consistent work methods

6. June 16 | Slide 6research based, people driven 6 Verbal: Instructions, training, meetings, Sound: alarms, Siren, fire alarm. Colour: ‘red’ = danger, ‘hot- spots’, hi-visibility jackets Written: SOP’s, Signs, Notices, Manuals. Reduce: the risk (physically) Prevent Error-Proofing Hierarchy PLEASE CLOSE THE DOOR Least effective methods Most effective methods

7. June 16 | Slide 7research based, people driven TEAM COMPOSITION - ESSENTIALS CROSS-FUNCTIONAL TEAM, drawn from key stakeholder groups OPERATOR INVOLVEMENT, to gain insights into document usability from a User viewpoint COMPLIANCE, For advice and support on compliance issues

8. June 16 | Slide 8research based, people driven TEAM COMPOSITION Bulk Supervisor Morgan Cunningham Bulk Operator Brian Cummins QA/Compliance Pamela Jones RFT Executive Jason Redmond Manufacturing Development Geraldine Doyle QC Executive Manus Treacy Op Ex Facilitator Marie Hayes Project Sponsor: Area Manager Michael Bradley

9. June 16 | Slide 9research based, people driven PROJECT TIMELINES

10. June 16 | Slide 10research based, people driven DEFINE THE PROBLEM Paperwork review process: It takes around 3 hours for each bulk paperwork review, before it proceeds to Q.C. department for final batch review and release. Errors in Batch Paperwork lead to: Reduced Quality, Increased Risk to patient safety Delays to product approvals, Increased Lead-time, and Increased Costs Resources tied up in Non-Value-Add activities

11. June 16 | Slide 11research based, people driven PROJECT GOALS Maximise accuracy of paperwork completion Shorten through-put time of batch paperwork Minimise Non-Value-Add activities Achieve a 36% improvement in Right-First-Time for Dovobet batch paperwork by December 2009 Achieve 75% R.F.T. to first-reviewer, by December 2009 DELIVERABLES

12. June 16 | Slide 12research based, people driven MEASUREMENT PHASE Company RFT metric provides results on a macro level: CORRECT PAPERWORK = 1 HIT >1 ERROR = 1 MISS Batch paperwork = 500 and 700 manual entries of Signatures/ Dates/ Data Entries, for an average 12 hour period The RFT metric is recorded by QC reviewer; Some errors already resolved by the TBBU reviewer Drill-down into detailed level was required

13. June 16 | Slide 13research based, people driven DESIGN OF METRIC Reporting criteria, that were already in use, did not identify and root-cause the paperwork errors so, the following error codes were designed to analyse errors during this project:

14. June 16 | Slide 14research based, people driven ERRORS - APRIL DOVOBET CAMPAIGN TOP 3 ERRORS ACCOUNT FOR 81% OF RFT ISSUES

15. June 16 | Slide 15research based, people driven INITIAL ANALYSIS Errors, by document type Lot Processing Record (LPR) 73% Cleaning records 15% Batch Reports 7% Other 5%

16. June 16 | Slide 16research based, people driven INITIAL ANALYSIS Results indicated the area of focus: Omission Errors on the Lot Processing Record Root Cause Analysis was carried out to:  Identify risk-increasing factors  Classify defects  Identify methods to mitigate these risk factors

17. June 16 | Slide 17research based, people driven CATEGORIES OF HUMAN ERROR Learning Gap errors –E.g. New worker, or worker not familiar with operation Memory gap errors –People have learnt but are unable to remember or use the information, when needed Inconsistency errors –Variability in task performance or poor standardisation of work method Application errors –Person knows how to do the task but makes a mistake Omission errors –Person knows how to do the task but forgets to do it Decision errors –Given the relevant information, an inappropriate decision is made

18. June 16 | Slide 18research based, people driven SOLVING OMISSION ERRORS Review fields and document layouts Use of colour, symbols, shapes, words to gain attention Use triggers and focusing aids to prevent Omission Errors Analyse & design documents for effectiveness of layout Documents must follow the real flow of a process The position of information affects processing and recall – place instructions in sequential order. www. Talsico.com

19. June 16 | Slide 19research based, people driven EXPLORING POSSIBLE CAUSES

20. June 16 | Slide 20research based, people driven COUNTER-MEASURES QUICK FEEDBACK ON ERRORS - Detect errors before they turn into defects DOCUMENT DESIGN – Reduce complexity, Standardise documents OWNERSHIP FOR QUALITY – Hold RFT awareness sessions with Operators, Seek Operator involvement CULTURE - Foster a supportive reporting culture

21. June 16 | Slide 21research based, people driven IMPLEMENTATION – 3 KEY AREAS 1. QUICK FEEDBACK ON ERRORS: Perform a trial of 100% source inspection, Goal: to eliminate errors before they turn into paperwork defects. 2. DOCUMENT RE-DESIGN - Perform an Operator-driven review of paperwork design to identify opportunities for improvements to the content, sequencing, layout or process of paperwork review. 3. COMMUNICATION: Hold RFT sessions with TBBU teams, to present RFT results, build awareness of cost-of- quality defects, and ask for input to improvement process

22. June 16 | Slide 22research based, people driven QUICK FEEDBACK ON ERRORS We had been using a final inspection model to attempt to catch paperwork defects, after the batch is completed. If these errors and omissions can be removed, at source, it reduces lead-time and frees up to valuable resources to work on value-add activities.

23. June 16 | Slide 23research based, people driven QUICK FEEDBACK ON ERRORS Proposed Solution - “Real-time review” - Self-check of paperwork while it is in progress, at regular intervals Operator self-inspection - On-line review offers an immediate way to check for errors as they crop up, rather than letting the defect get through to the end and inspecting it out. Carried out Trial of Self-Inspection in July…..

24. June 16 | Slide 24research based, people driven RESULTS SELF-CHECK TRIAL, JULY 2009 Comments: 31% reduction overall in error-rate in P4 Dovobet campaign; and a knock-on paperwork improvement is also being seen in P1 and P3 bulk facilities

25. June 16 | Slide 25research based, people driven DOCUMENT RE-DESIGN Carried out in collaboration with Operator to isolate the problem areas: Do users have persistent difficulty with certain sections of LPR? Are certain forms hard to fill in? Team posted the LPR in a common area – asked Operators to highlight areas of difficulty & make remarks Colour-coding was introduced to improve readability and provide better visual prompts

26. June 16 | Slide 26research based, people driven TRIAL RESULTS – COLOUR-CODED LPR

27. June 16 | Slide 27research based, people driven COMMUNICATION RFT Sessions were held with Operators: To build awareness of errors that occur with paperwork entries To ask for Operator input, to the improve the layout of paperwork To focus on finding the joint solutions Provide refresher training on record-keeping

28. June 16 | Slide 28research based, people driven COMMUNICATION RFT notice-board in the area, shows the “Top 3” errors and updates on latest RFT weekly results A3 project format, displayed in Main lobby area, updates everyone in company about progress of project Lean Philosophy – the Visual factory – will develop and improve communication over the coming months & years

29. June 16 | Slide 29research based, people driven OVERALL RESULTS

30. June 16 | Slide 30research based, people driven OVERALL RESULTS REMARKS: Week 43 and 44: Decline in RFT to TBBU reviewer: Last dovobet campaign was week 41/42, using the colour-coded LPR. There were no Daivobet campaigns in week 43/44, so TBBU reverted to LPR with no colour coding

31. June 16 | Slide 31research based, people driven OVERALL RESULTS

32. June 16 | Slide 32research based, people driven OVERALL RESULTS REMARKS: Week 43 and 44: Decline in RFT to TBBU reviewer: Last dovobet campaign was week 41/42, using the colour-coded LPR. There were no Daivobet campaigns in week 43/44. We will review the results of week 46 daivobet campaign data, to review whether colour-coding makes it easier to get sign-offs correct.

33. June 16 | Slide 33research based, people driven WHAT WORKED WELL? RFT is over 75% since week 45 Life is now easier for document reviewers – less errors and less review time DMAIC model, Structured problem-solving model Operator Empowerment – Getting involvement from process operators is invaluable

34. June 16 | Slide 34research based, people driven KEY CHALLENGES At early stages of this project, much useful debate was generated about the sources of human error Diagnosis of the underlying issues is challenging; Team avoided extra secondary checks; We did not appeal to people to try harder to achieve RFT. Project due to finish in December 2009. Team will quantify the benefits, prepare Close-out Reports NEXT STEPS

35. June 16 | Slide 35research based, people driven IN CONCLUSION... In many cases, the system can be improved to reduce propensity for human error There is considerable scope for addressing usability issues in our document design We need to evaluate design, from each user’s Perspective, across the entire document life-cycle