RIGHT-FIRST-TIME PROJECT

Topicals Bulk Business Unit

LEO Pharma
Marie Hayes
OpEx Department

research based, people driven

November 14 | 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 14 | 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 14 | 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 14 | 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 - 950s
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 14 | Slide 5

Error-Proofing
Hierarchy

Most
effective
methods

Prevent
Reduce:
the risk (physically)

Sound: alarms,
Siren, fire alarm.

Colour: red = danger, hotspots, hi-visibility jackets

PLEASE
CLOSE
THE
DOOR

Written: SOPs, Signs,

Notices, Manuals.

Verbal: Instructions, training,

meetings,
research based, people driven

November 14 | Slide 6

Least
effective
methods

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 14 | 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 14 | Slide 8

PROJECT TIMELINES
Q2 09

ID

ERROR-PROOFING PROJECT

Start by:

Finish by:

Apr

DEFINE : Based on Data Analysis:

Identify top 3 paperwork RFT problems
MEASURE: - Define which measure
2
will demonstrate impact of actions
ANALYSE: - Based on top 3
3
problems, draft a range of solutions
ANALYSE: - Gather RFT data on the
4
current dovobet campaign
ANALYSE: - Present data to Ops and
5
draft solutions with Operators help
IMPLEMENT solutions - In place 3
6
days before wk 24 d/bet campaign
CONTROL: Measure to determine
7
impact of changes, Adjust, if needed
PHASE 2: Repeat project steps above
8
for next round of problem-solving
PHASE 3: Repeat project steps above
9
for next round of problem-solving
PHASE 4: Repeat project steps above
10
for next round of problem-solving
1

23/03/2009

10/04/2009

3w

22/04/2009

28/04/2009

1w

29/04/2009

12/05/2009

2w

25/05/2009

29/05/2009

1w

25/05/2009

29/05/2009

1w

29/05/2009

04/06/2009

1w

15/06/2009

19/06/2009

1w

24/06/2009

18/08/2009

8w

01/09/2009

26/10/2009

8w

26/10/2009

18/12/2009

8w

research based, people driven

Q3 09

Q4 09

Duration

November 14 | Slide 9

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec

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 14 | 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 14 | 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/ 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

research based, people driven

November 14 | 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:

1
2
3
4
5
6
7
8

DESCRIPTION OF ERROR
MISSING SIGNATURE
WRONG DATE FORMAT
MISSING DATE
WRONG DATE ENTERED
N/A NOT SIGNED AND DATED
OVER-WRITES
INCORRECT DATA ENTRY
CALCULATION ERRORS

research based, people driven

November 14 | Slide 13

ERRORS - APRIL DOVOBET CAMPAIGN

Breakdown of Errors in April Campaign of Dovobet Ointment in P4 facility
15%
1%

1%

Missing Signature
43%

Missing Date
Incorrect Data Entry
N/A Not Signed & Dated
Overwrites

16%

Wrong Date Entered

Missing Data Entry
1%
23%

TOP 3 ERRORS ACCOUNT FOR 81% OF RFT ISSUES

research based, people driven

November 14 | 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 14 | Slide 15

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

research based, people driven

November 14 | 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 14 | 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 14 | Slide 18

EXPLORING POSSIBLE CAUSES

research based, people driven

November 14 | 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 14 | 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 14 | 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 14 | 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 14 | Slide 23

RESULTS SELF-CHECK TRIAL, JULY 2009

No. of Errors in 3 Campaigns of Dovobet
Ointment in P4

Before Self-check

at
M
ur
is
s
e
or
in
N
g
r
ec
/A
D
at
No t D
t S ata e
ig
ne Ent
ry
d
&
Da
W
te
O
ro
d
v
er
ng
w
D
rit
a
es
te
M
is
sin Ent
er
g
ed
D
at
a
En
try

Self-check trial

After Self-check

In
c

M
is
sin
g

Si
gn

No. of Errors

80
70
60
50
40
30
20
10
0

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

research based, people driven

November 14 | 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 14 | Slide 25

TRIAL RESULTS COLOUR-CODED LPR

Comparison of Daivobet Errors - Trial of colour-coded LPR
50
45
40

Errors

35
30

5 batches (Black
& White LPR)

25
20

5 Batches (Colour
-coded LPR)

15
10
5
y
En
tr
a
D
at

at
e

ro
ng

is
si
ng

En
te

rw
ri
te
ve

D
&

re
d

d
at
e

y
Si
gn
ed

N
/A

N
ot

or
re
ct

at
a

En
tr

D
at
e
is
si
ng

In
c

is
si
ng

Si
gn
at
ur
e

Error Category

research based, people driven

November 14 | 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 14 | Slide 27

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

research based, people driven

November 14 | Slide 28

OVERALL RESULTS
AVERAGE NO. OF ERRORS (per batch) 2009
70

50
40

Average Error-count, (per

batch)
Trendline

30
20
10

47

45
46

43
44

41
42

39
40

37
38

35
36

31
34

29
30

27
28

25
26

0
23
24

Errror Count

60

Week

research based, people driven

November 14 | Slide 29

OVERALL RESULTS
NUMBER OF ERRORS - BULK BATCH
PAPERWORK WEEKLY 2009

MISSING DATE

100

INCORRECT DATA ENTRY

90

N/A NOT SIGNED AND DATED

80
No of errors

MISSING SIGNATURE

OVER-WRITES

70

WRONG DATE ENTERED

60

WRONG DATE FORMAT

50

MISSING DATA ENTRY

40

CALCULATION ERRORS

30

Trendline

20
10
0
22 23 24 25 26 27 28 29 30 31 34 35 36 37 38 39 40 41 42 43 44 45 46 47

Week number
ERROR-PROOFING PROJECT
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 14 | Slide 30

OVERALL RESULTS
Errors in Dovobet Paperwork
7 consecutive campaigns - April to Oct 2009
50

No of Errors

40

Missing Signature

30

Missing Date

20

Incorrect Data Entry

10

N/A Not Signed &

Dated
Overwrites

0
1

7 Dovobet Campaigns

Wrong Date Entered

Missing Data Entry
Linear (Missing
Signature)

research based, people driven

November 14 | Slide 31

OVERALL RESULTS
RIGHT FIRST TIME TO TBBU REVIEWER WEEKLY RESULTS 2009
100%
90%

88%

80%

80%
75%

Target 75%

70%
64%

60%

55%

50%

Right-First-Time

44%

40%

38%
TREND-LINE

30%
20%
0%

15%

14%

10%

9%

8%
0%
18

19

20

0%
21

22

0%
23

24

25

26

27

28

29

0%
30

31

35

36

37

38

39

40

41

42

43

44

45

46

47

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 14 | 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 14 | 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 14 | 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 users Perspective,
across the entire document life-cycle

research based, people driven

November 14 | Slide 35