Professional Documents
Culture Documents
OVERVIEW
PROJECT BACKGROUND
GOALS - Deliverables
METHODS DMAIC model, Error-proofing
ACTIONS Data-gathering, Analysis
RESULTS Implementing findings
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
November 14 | Slide 3
METHODOLOGY
Sustaining the gains
1. DEFINE
SIPOC
Process Map
5. CONTROL
4. IMPROVE
Plan and implement
actions to improve
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
November 14 | Slide 5
Error-Proofing
Hierarchy
Most
effective
methods
Prevent
Reduce:
the risk (physically)
Sound: alarms,
Siren, fire alarm.
PLEASE
CLOSE
THE
DOOR
November 14 | Slide 6
Least
effective
methods
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
Michael Bradley
November 14 | Slide 8
PROJECT TIMELINES
Q2 09
ID
ERROR-PROOFING PROJECT
Start by:
Finish by:
Apr
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
Q3 09
Q4 09
Duration
November 14 | Slide 9
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
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
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
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
November 14 | Slide 13
1%
Missing Signature
43%
Missing Date
Incorrect Data Entry
N/A Not Signed & Dated
Overwrites
16%
November 14 | Slide 14
INITIAL ANALYSIS
Errors, by document type
Lot Processing Record (LPR)
73%
Cleaning records
15%
Batch Reports
7%
Other
5%
November 14 | Slide 15
INITIAL ANALYSIS
Results indicated the area of focus:
November 14 | Slide 16
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
November 14 | Slide 17
November 14 | Slide 18
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
November 14 | Slide 20
November 14 | Slide 21
November 14 | Slide 22
November 14 | Slide 23
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
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
November 14 | Slide 25
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
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
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
November 14 | Slide 28
OVERALL RESULTS
AVERAGE NO. OF ERRORS (per batch) 2009
70
50
40
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
November 14 | Slide 29
OVERALL RESULTS
NUMBER OF ERRORS - BULK BATCH
PAPERWORK WEEKLY 2009
MISSING DATE
100
90
80
No of errors
MISSING SIGNATURE
OVER-WRITES
70
60
50
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
10
0
1
7 Dovobet Campaigns
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.
November 14 | Slide 32
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
November 14 | Slide 34
IN CONCLUSION...
In many cases, the system can be improved to reduce
propensity for human error
November 14 | Slide 35