RIGHTFIRSTTIME PROJECT Topicals Bulk Business Unit LEO Pharma

RIGHT-FIRST-TIME PROJECT Topicals Bulk Business Unit LEO Pharma Marie Hayes Op. Ex Department research based, people driven November 20 | LEO Pharma

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? research based, people driven November 20 | Slide 2

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 research based, people driven November 20 | Slide 3

METHODOLOGY Sustaining the gains 1. DEFINE Close out Actions SIPOC Process Map 5. CONTROL 4. IMPROVE Plan and implement actions to improve research based, people driven The DMAIC Cycle 2. MEASURE Gather data Pareto, Bar chart 3. ANALYSE Root Cause Analysis November 20 | Slide 4

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 research based, people driven November 20 | Slide 5

Error-Proofing Hierarchy Prevent Most effective methods Reduce: the risk (physically) Sound: alarms, Siren, fire alarm. Colour: ‘red’ = danger, ‘hot -spots’, hi-visibility jackets PLEASE CLOSE THE DOOR Written: SOP’s, Signs, Notices, Manuals. Verbal: Instructions, training, meetings, research based, people driven November 20 | Slide 6 Least effective methods 6

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 research based, people driven November 20 | Slide 7

TEAM COMPOSITION • • Bulk Supervisor Bulk Operator QA/Compliance RFT Executive Manufacturing Development QC Executive Op Ex Facilitator Morgan Cunningham Brian Cummins Pamela Jones Jason Redmond Geraldine Doyle Manus Treacy Marie Hayes • Project Sponsor: Area Manager research based, people driven Michael Bradley November 20 | Slide 8

PROJECT TIMELINES research based, people driven November 20 | Slide 9

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 research based, people driven November 20 | Slide 10

PROJECT GOALS • Maximise accuracy of paperwork completion • Shorten through-put time of batch paperwork • Minimise Non-Value-Add activities DELIVERABLES • 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 research based, people driven November 20 | Slide 11

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/ 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 research based, people driven November 20 | Slide 12

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: research based, people driven November 20 | Slide 13

ERRORS - APRIL DOVOBET CAMPAIGN TOP 3 ERRORS ACCOUNT FOR 81% OF RFT ISSUES research based, people driven November 20 | Slide 14

INITIAL ANALYSIS Errors, by document type Lot Processing Record (LPR) 73% Cleaning records 15% Batch Reports 7% Other 5% research based, people driven November 20 | Slide 15

INITIAL ANALYSIS Results indicated the area of focus: Omission Errors on the Lot Processing Record • Root Cause Analysis was carried out to: v. Identify risk-increasing factors v. Classify defects v. Identify methods to mitigate these risk factors research based, people driven November 20 | Slide 16

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 research based, people driven November 20 | Slide 17

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 research based, people driven November 20 | Slide 18

EXPLORING POSSIBLE CAUSES research based, people driven November 20 | Slide 19

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 research based, people driven November 20 | Slide 20

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-ofquality defects, and ask for input to improvement process research based, people driven November 20 | Slide 21

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. research based, people driven November 20 | Slide 22

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…. . research based, people driven November 20 | Slide 23

RESULTS SELF-CHECK TRIAL, JULY 2009 Comments: 31% reduction overall in error-rate in P 4 Dovobet campaign; and a knock-on paperwork improvement is also being seen in P 1 and P 3 bulk facilities research based, people driven November 20 | Slide 24

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 research based, people driven November 20 | Slide 25

TRIAL RESULTS – COLOUR-CODED LPR research based, people driven November 20 | Slide 26

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 research based, people driven November 20 | Slide 27

COMMUNICATION • RFT notice-board in the area, shows the “Top 3” errors and updates on latest RFT weekly results • A 3 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 research based, people driven November 20 | Slide 28

OVERALL RESULTS research based, people driven November 20 | Slide 29

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 research based, people driven November 20 | Slide 30

OVERALL RESULTS research based, people driven November 20 | Slide 31

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. research based, people driven November 20 | Slide 32

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 research based, people driven November 20 | Slide 33

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. NEXT STEPS • Project due to finish in December 2009. Team will quantify the benefits, prepare Close-out Reports research based, people driven November 20 | Slide 34

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 research based, people driven November 20 | Slide 35