leo human error network event dec 2nd 2009

8/10/2019 Leo Human Error Network Event Dec 2nd 2009

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November 14 | LEO Pharma research based, people driven

RIGHT-FIRST-TIME PROJECT

Topicals Bulk Business UnitLEO Pharma

Marie Hayes

OpEx Department



November 14 | 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?




BACKGROUND

• January 2009, a Value Stream Mapping exercise wascarried out, to identify areas to focus our improvementactivities

• 43 key priorities were identified and prioritised

• Error Reduction in Batch-Paperwork was identified as akey priority

• Project Scope: Dovobet ointment




METHODOLOGY

5. CONTROL

4. IMPROVE 3. ANALYSE

2. MEASURE

1. DEFINE

TheDMAIC

Cycle

SIPOC

Process Map

Gather data

Pareto, Bar chart

Root Cause AnalysisPlan and implement

actions to improve

Sustaining the gains

Close out Actions




ERROR-PROOFING METHODS

• Error-Proofing: The process of anticipating, preventing, &

detecting errors which adversely affect customers & resultin waste – developed by Shigeo Shingo - 950’s

• Error Analysis, Deviation Analysis & Error Elimination

• Error-proofing Documentation – Affordance Techniques:Simplify, Use Colours, Photographs, Symbols, ProcessFlow 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

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

PLEASECLOSE

THE

DOOR

Leasteffectivemethods

Mosteffectivemethods

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http://slidepdf.com/reader/full/leo-human-error-network-event-dec-2nd-2009 7/35November 14 | Slide 7research based, people driven

TEAM COMPOSITION - ESSENTIALS

• CROSS-FUNCTIONAL TEAM, drawn from key stakeholdergroups

• OPERATOR INVOLVEMENT, to gain insights into document

usability from a User viewpoint

• COMPLIANCE, For advice and support on complianceissues



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



PROJECT TIMELINES

ID ERROR-PROOFING PROJECT Start by: Finish by: Duration

Apr May Jun Jul Aug Sep

1 3w10/04/200923/03/2009DEFINE : Based on Data Analysis:

Identify top 3 paperwork RFT problems

3 2w12/05/200929/04/2009 ANALYSE: - Based on top 3

problems, draft a range of solutions

5 1w29/05/200925/05/2009 ANALYSE: - Present data to Ops and

draft solutions with Operators’ help

7 1w19/06/200915/06/2009CONTROL: Measure to determine

impact of changes, Adjust, if needed

Q2 09

6 1w04/06/200929/05/2009IMPLEMENT solutions - In place 3

days before wk 24 d/bet campaign

2 1w28/04/200922/04/2009MEASURE: - Define which measure

will demonstrate impact of actions

8w18/08/200924/06/2009PHASE 2: Repeat project steps above

for next round of problem-solving

Q3 09

8

8w26/10/200901/09/2009PHASE 3: Repeat project steps abovefor next round of problem-solving

Q4 09

Oct Nov Dec

4 1w29/05/200925/05/2009 ANALYSE: - Gather RFT data on the

current dovobet campaign

10

9

8w18/12/200926/10/2009PHASE 4: Repeat project steps above

for next round of problem-solving



DEFINE THE PROBLEM

Paperwork review process: It takes around 3 hours for each bulkpaperwork review, before it proceeds to Q.C. department forfinal batch review and release.

Errors in Batch Paperwork lead to:

• Reduced Quality, Increased Risk to patient safety

• Delays to product approvals, Increased Lead-time, andIncreased Costs

• Resources tied up in Non-Value-Add activities




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




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 ofSignatures/ Dates/ Data Entries, for an average 12 hourperiod

• The RFT metric is recorded by QC reviewer; Some errors

already resolved by the TBBU reviewer

• Drill-down into detailed level was required




DESIGN OF METRIC

• Reporting criteria, that were already in use, did not identify and

root-cause the paperwork errors so, the following error codes weredesigned to analyse errors during this project:

DESCRIPTION OF ERROR

1 MISSING SIGNATURE

2 WRONG DATE FORMAT3 MISSING DATE4 WRONG DATE ENTERED

5 N/A NOT SIGNED AND DATED

6 OVER-WRITES7 INCORRECT DATA ENTRY

8 CALCULATION ERRORS




ERRORS - APRIL DOVOBET CAMPAIGN

Breakdown of Errors in April Campaign of Dovobet Ointment in P4 facility

1%

1%

16%

1%

15%

23%

43%

Missing Signature

Missing Date

Incorrect Data Entry

N/A Not Signed & Dated

Overwrites

Wrong Date Entered

Missing Data Entry

TOP 3 ERRORS ACCOUNT FOR 81% OF RFT ISSUES




INITIAL ANALYSIS

Errors, by document type

Lot Processing Record (LPR) 73%

Cleaning records 15%

Batch Reports 7%

Other 5%




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




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 workmethod

• Application errors – Person knows how to do the task but makes a mistake

• Omission errors

– Person knows how to do the task but forgets todo it

• Decision errors

– Given the relevant information, an inappropriate decision is made




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




COUNTER-MEASURES

• QUICK FEEDBACK ON ERRORS - Detect errors before

they turn into defects

• DOCUMENT DESIGN – Reduce complexity, Standardisedocuments

• OWNERSHIP FOR QUALITY – Hold RFT awarenesssessions with Operators, Seek Operator involvement

• CULTURE - Foster a supportive reporting culture




IMPLEMENTATION – 3 KEY AREAS

• 1. QUICK FEEDBACK ON ERRORS: Perform a trial of

100% source inspection, Goal: to eliminate errors beforethey turn into paperwork defects.

• 2. DOCUMENT RE-DESIGN - Perform an Operator-drivenreview of paperwork design to identify opportunities for

improvements to the content, sequencing, layout orprocess of paperwork review.

• 3. COMMUNICATION: Hold RFT sessions with TBBUteams, to present RFT results, build awareness of cost-of-

quality defects, and ask for input to improvement process




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 towork on value-add activities.




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 animmediate way to check for errors as they crop up, ratherthan letting the defect get through to the end and

inspecting it out.

• Carried out Trial of Self-Inspection in July…..




RESULTS SELF-CHECK TRIAL, JULY 2009

No. of Errors in 3 Campaigns of Dovobet

Ointment in P4

01020

304050607080

M i s s i n g

S i g n

a t u r e

M i s s i n g

D a t e

I n c o r r e c t D a

t a E n

t r y

N / A N o t

S i g n e

d & D a t e

d

O v e r w r i t e

s

W r o n g D

a t e E n t e

r e d

M i s s i n

g D a t a

E n t r

y

N o . o f E r r o r Before Self-check

Self-check trial

After Self-check

Comments: 31% reduction overall in error-rate in P4 Dovobet campaign; and aknock-on paperwork improvement is also being seen in P1 and P3 bulk facilities




DOCUMENT RE-DESIGN

Carried out in collaboration with Operator to

isolate the problem areas:

• Do users have persistent difficulty with certain sections ofLPR?

• Are certain forms hard to fill in? Team posted the LPR in acommon area – asked Operators to highlight areas ofdifficulty & make remarks

• Colour-coding was introduced to improve readability andprovide better visual prompts




TRIAL RESULTS – COLOUR-CODED LPR

Comparison of Daivobet Errors - Trial of colour-coded LPR

0

5

10

1520

25

30

35

40

45

50

M i s s i n

g S i g

n a t u r e

M i s s

i n g D a

t e

I n c o

r r e c t D a t a E n

t r y

N / A

N o t S

i g n e d

& D a t e d

O v e r w r

i t e s

W r o n g D a

t e E n t e r e d

M i s s i n g

D a t a E n

t r y

Error Category

E

r r o r s

5 batches (Black& White LPR)

5 Batches (Colour-coded LPR)




OVERALL RESULTS

AVERAGE NO. OF ERRORS (per batch) 2009

0

10

20

30

40

50

60

70

2 3 2 4 2 5 2 6 2 7 2 8 2 9 3 0 3 1 3 4 3 5 3 6 3 7 3 8 3 9 4 0 4 1 4 2 4 3 4 4 4 5 4 6 4 7

Week

E r r r o r C o

u n t

Average Error-count, (perbatch)

Trendline




OVERALL RESULTS

NUMBER OF ERRORS - BULK BATCH

PAPERWORK WEEKLY 2009

0

10

20

30

40

50

60

70

80

90

100

2 2 2 3 2 4 2 5 2 6 2 7 2 8 2 9 3 0 3 1 3 4 3 5 3 6 3 7 3 8 3 9 4 0 4 1 4 2 4 3 4 4 4 5 4 6 4 7

Week number

ERROR-PROOFING PROJECT

N o

o f e r r o r s

MISSING SIGNATURE

MISSING DATE

INCORRECT DATA ENTRY

N/A NOT SIGNED AND DATED

OVER-WRITES

WRONG DATE ENTERED

WRONG DATE FORMAT

MISSING DATA ENTRY

CALCULATION ERRORS

Trendline

REMARKS: Week 43 and 44: Decline in RFT to TBBU reviewer: Last dovobet campaign was week 41/42, usingthe colour-coded LPR. There were no Daivobet campaigns in week 43/44, so TBBU reverted to LPR with no colourcoding




OVERALL RESULTS

Errors in Dovobet Paperwork7 consecutive campaigns - April to Oct 2009

0

10

20

30

40

50

1 2 3 4 5 6 7

7 Dovobet Campaigns

N o

o f E r r o

r s Missing Signature

Missing Date

Incorrect Data Entry

N/A Not Signed & DatedOverwrites

Wrong Date Entered

Missing Data Entry




OVERALL RESULTSRIGHT FIRST TIME TO TBBU REVIEWER -

WEEKLY RESULTS 2009

0% 0%

8% 9%

0%

14%

0%

15%

38%

64%

88%

80%

75%

55%

44%

0%

10%

20%

30%

40%50%

60%

70%

80%

90%

100%

18 19 20 21 22 23 24 25 26 27 28 29 30 31 35 36 37 38 39 40 41 42 43 44 45 46 47

Right-First-Time

TREND-LINE

Target 75%

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 reviewwhether colour-coding makes it easier to get sign-offs correct.




WHAT WORKED WELL?

• RFT is over 75% since week 45

• Life is now easier for document reviewers – less errorsand less review time

• DMAIC model, Structured problem-solving model

• Operator Empowerment – Getting involvement from

process operators is invaluable




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 appealto 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



IN CONCLUSION...

• In many cases, the system can be improved to reducepropensity for human error

• There is considerable scope for addressing usability issuesin our document design

• We need to evaluate design, from each user’s Perspective,across the entire document life-cycle