Lean Professional Deliverables - Week 4 of 6

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Deliverables Report
Lean Professional®
Training Week 4
Name: Brandon Kingcaid

Deliverables Report Lean Professional Training
© Lean Alliance GmbH • All rights reserved • www.lean-alliance.com Page 2
 2009 YTD Bag Forming Rejects.
Total Quality Control
2.1
2009 YTD Bag Forming Rejects
412,143
197,147
161,471
46,748
34,871 34,443
10,807 7,893 3,469 1,831 1,712 974 667 393 203 28 25 20
45.1%
66.6%
84.3%
89.4%
93.2%
96.9% 98.1% 99.0% 99.4% 99.6% 99.7% 99.9% 99.9% 100.0% 100.0% 100.0% 100.0% 100.0%
-
50,000
100,000
150,000
200,000
250,000
300,000
350,000
400,000
450,000
FillV
o
lu
m
e
P
ro
c
es
s
S
a
m
p
les
L
e
ake
rs
D
ro
p
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ed
B
ag
sE
x
tra
U
n
its
B
ag
D
am
a
ge
M
iss
in
g
C
a
p
sL
in
e
J
am
P
lea
ts
D
irty
M
isa
lig
n
e
d
S
ad
d
leA
ir
V
o
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m
e
P
M
B
a
d
O
/W
labe
l
S
a
dd
le
D
am
ag
e
D
e
f.
S
to
p
p
ers
M
iss
in
g
H
a
n
g
e
r
0.00%
20.00%
40.00%
60.00%
80.00%
100.00%
120.00%
Reject Qty Cum %
Top 3 (84%):
1) Fill Volume
2) Process Samples
3) Leakers

 Fishbone diagram – Fill Volume Defects
Focus areas to reduce Fill Volume Defects
1) Machine settings; setup & in-process adjustments → DOE
2) Interruptions in filling cycle → eliminate root causes to increase OEE 2.1

 Nominal = 1075 ml
Some consistency, but many spikes 4.2

 Create a SPC chart for a critical parameter in your process.
Need to find sources of variation - DOE 4.2

 Fill Volume Histogram
Distribution leans towards
the high spec, possible
solution cost savings in
shifting distribution to lower
spec
4.2

Before Improvement After Improvement
Description of the process
Process: Sample bag identification for pressure cuff testing
Problem: Mistakes made while writing the pallet information and when
reading the written pallet information
Solution: Use an automated printer scanner to scan the pallet information
from the sterilizer tag and print it legibly to attach to bag
Key improvement: Possibility of marking wrong pallet information was
eliminated
Inspection Method
Escapement/
Release Mechanism
Regulation Method
Source Inspection X Contact Method X Control Method X
Inspection with direct
feedback (SeCS)
Fixed Value Method Warning Method
Inspection with
indirect feedback
(SuCS)
Motion Step Method
Hand written pallet
id info can be
mistakenly written
or read.
Automated printing
prevents errors in
bag id.
 Create a Poka Yoke system matrix.Poka Yoke
2.4

Process: Pallet jack battery connects to the pallet jack for operation.
Problem: Pallet jack is connected to an incompatible battery.
Solution: Shorten connecting wires and add an adapter that requires the
correct battery port to be installed
Key improvement: Incompatible pallet jacks and batteries cannot be
connected
Inspection Method
Escapement/
Release Mechanism
Regulation Method
Source Inspection Contact Method X Control Method X
feedback (SeCS)
Inspection with
indirect feedback
(SuCS)
X
Motion Step Method
Incorrect charging
ports can be
connected and lead
to battery
malfunction
Battery ports cannot
be connected
without the correct
adapter
2.4

Process: Operator manually records key process parameters into batch
record to verify validated state
Problem: Omissions and out of spec parameters cause a non conforming lot
report to be issued
Solution: The electronic batch record requires input of parameters that are
within spec to close out the batch
Key improvement: Omissions and out of spec parameters are immediately
addressed while the batch is still open
Inspection Method
Escapement/
Release Mechanism
Regulation Method
Source Inspection Contact Method Control Method
feedback (SeCS)
Inspection with
indirect feedback
(SuCS)
Motion Step Method
Documentation
errors occur such as
omissions and out of
spec parameters
EBR requires that all
parameters be taken and
indicates when a parameter
is out of spec
2.4

Process: Label plates are stored in racks when not being used in machines.
Problem: During insertion and removal, the plates can get scratched on the
steel dividers and other plates.
Solution: Designed a rack that allows only one plate per slot and soft pvc
construction.
Key improvement: Plates no longer damaged during storage.
Inspection Method
Escapement/
Release Mechanism
Regulation Method
feedback (SeCS)
Inspection with
indirect feedback
(SuCS)
Motion Step Method
Label plates were
stacked on
themselves and
scraped on the steel
dividers
Label plates are stored in a
pvc rack with no way of
being oriented incorrectly
2.4

Process: Pallets are manually transported between areas.
Problem: Non-sterile product can be transported to the sterile side.
Solution: Install a one way spike system to restrict pallet transport from
non-sterile to sterile side.
Key improvement: Empty pallets can travel to non-sterile side, but full pallets
cannot travel to the sterile side.
Inspection Method
Escapement/
Release Mechanism
Regulation Method
feedback (SeCS)
Inspection with
indirect feedback
(SuCS)
Motion Step Method
Non-sterile product
can be transported
to the sterile side.
Pallets can only be
brought to the non-
sterile side
2.4

PDCA 1
• normally
handwritten in the
sheet (scan) or
exceptionally
typed.
Product/type:
Plant: Line:
When was the problem/ the defect observed for
the first time?
Description of the problem (facts!):
Shift:Machine:
3
1. Parts lists/bills of materials
2. Graphs, drawings
3. Pareto analysis
4. Diagrams / analysis
5. Tracing of quanitities (LPMS)
6. Defect logs
7. Assembly losses
8. Machinery break downs
9. Specification limits (capabilities)
10. SPC-diagrams
11. Process data sheets
12. Quality gate
13. Other data
14. Shift records
15. Control plans
16. Production flow
17. Process descriptions
18. Manufacturing instructions
19. ...
No.
!
Is the problem a repetition defect?
no, defect is always found at the shop floor
2.2
Owner:
What is the problem report of the machine?
Department:
Date of issue:
NA
sketch, component drawing, photo …(highlight location)
#
Sheet 1
(problem specification)PDCA Sheet Shopfloor CIP
customer(s):
Time:
0Status
Discoverer of the defect (employee):
Which problem occurred?
Date of breakdown:
Component: Defect part:
WhoX
Can this defect go up to the client, and there respectively lead to a breakdown ?
Present teamleader:
yes
Immediate actions (which actions assure that no defectivet parts go through to the client?)
Until when StatusAction
Long Pham /
Brandon
12/31/2008
Retrained operators to pull and ID samples at the pallet
Until all are
trained
Supervisors
1
Escalationmodel - Which supervisors got informed?Problem solving team:
Problem owner:
Team members:
Long Pham
All Excel Supervisors
2
Status
Supporting data:
Long Pham, Catherine Ho, Brandon Kingcaid, Robert Otanes, Ed Martinez, Junior Arriaga
Supervisors
How is the trend
(increasing, staying steady, decreasing)?
What has to be completed before the start of the analysis?
Supervisors
steady
Interview involved employee to see how the defect occurred
No. Who?
1
Since the first discovery, the recurrent has been intermittent - YTD 12 occurrences
At the final batch record review
Complete investigation report (IR) indicating corrective / preventive action plan
At the samples collecting step, component still deemed ok
NA
How has the process performed since then (Is
the occurence regular or irregular?)
At which manufacturing step can you observe
the problem/ the defect?
At which manufacturing step was the
component still o.k., respectively the problem
not there yet?
How many components dropped out since the
defect appeared?
Pressure cuff samples identified incorrectly
and verified through the following Poka-Yoke/source inspection/fast reaction cycle:
Yes
Problem first identified in late 2007
2.1
2 Identify alternative method for ID samples
1
6.2

PDCA 2
--
--
-- --
does this happen?
does this happen?
does this happen?
does this happen?
does this happen?
does this happen?
does this happen?
Why ...
does this happen?
does this happen?
Repetitive information
similar to other batches
Handwriting legibility
does this happen?
Human error making
assumption
Illegible written
information
Pallet location too far
5 x Why …
Operator writes down
wrong pallet #
Pressure cuff personnel
misreads samples
Samples pulled from the
line instead of the pallet
Step 2: asign / priortize the 3 most likely ones of the possible causes.
Step 1: generate possible causes of defects / basis is sheet 1 (problem specification)
cause 4 cause 5 cause 6
man machine
Step 3 / round 2 - only if needed: question exactly the most possible causesStep 3 / round 1: question exactly the most possible causes
4
Pressure cuff
samples
identified
incorrectly
defect:
cause 1 cause 2 cause 3
methodology environment
PDCA Sheet Shopfloor CIP
#
Sheet 2
(root cause analysis)
material
measurement equipment
Operator writes wrong pallet
number
Too many activities going on
causes distraction
Pressure cuff personnel misreads
the identified samples
Operator pulls sample from line
instead of at pallet
6.2

PDCA 3
Research NLR Team 8/1/08
5
+
6
StatusUntil when?Who?Prio
Brandon 12/1/08
#
Who?Result:
Assess programming
requirements
Brandon 1/1/094 Submit purchase order
StatusHow? Who? Until when? Status
1
Until when?No.
2 Select vendor for handheld barcode scanner/printer 11/1/08
3 Bring in loaner to test unit Brandon
4/1/09
Check robustness
Brandon/
Supervisors
Implementation
(if actions are successful)
Effectiveness Inspection (attempt)
7/1/09
Implementation plan
Brandon/
Supervisors
PDCA Sheet Shopfloor CIP
Sheet 3
(Actions)
5 Implement handheld barcode scanner/printer NLR Team 2/1/09 Submit CCR
Brandon/
Supervisors
Actions (also for evidence of the causes)
2/1/09
11/1/08
Brandon
More focus needed on check and act 6.2

Many steps can contribute
to a reject – fragile process
 Process Flow Diagram: Form, Fill, Seal (primary bag forming)
4.2

Project list
Before After
%
Improvement
Annualized
Savings ($)
1-off
cashflow
Value Stream Projects
1 Value Stream Planning
1.1 VSM Waste identification 90.0% 100%
1.2 VSD Future state vision to drive towards 0.0% #DIV/0!
2 Basic Waste Reduction (Point Kaizen)
2.1 Increase OEE in Bag Forming and Packing
Availability, Performance, Quality
Calculations
60.5% 100% percentage
2.2 6S 6S Audit Score 40.0% 100% radar chart
2.3 LPMS Boards Increased awareness and teamwork 5.0% 100% open action items
2.4 Mistake Proofing (Poka Yoke) Decreased employee/machine defects 20.0% 100% Deviations
3 Pacemaker
3.1 Increase Sterilization Capacity Increased capacity and flow 60.0% 100% capacity
3.2 SMED Reduced changeover of a vessel 60.0% 100% minutes
3.3 Level Load Production Decreased Waiting for a sterilizer 40.0% 100% waiting time
4 Flow production (Flow Kaizen)
4.1 Tray Load/Unload Automation Decreased Labor Costs 15.0% 100% dollars
4.2 Standard Work in Primary, Overwrap & Packing Consistent, Repeatable Cycle Times 10.0% 100% seconds
4.3 Pre-sterile / Post-sterile pallet staging system Decreased Tray Damage & Repairs 5.0% 100% dollars
4.4 Reduce Quarantine Cycle Time Release Time #DIV/0! seconds
5 Kanban (Pull Kaizen)
5.1 Kanban Loop Kanban Cards #DIV/0!
5.2 Transport Kanban #DIV/0!
5.3 Production Kanban #DIV/0!
5.4 Milkrun Level Loading #DIV/0!
5.5 Triangle Kanban/ Batch Building Level Loading #DIV/0!
5.6 Saddle Kanban Days Inventory 80.5% 100% days
5.7 Inventory Reduction Days Inventory days
5.8 Heijunka Scheduling Board Level Loading
6 PDCA
6.1 Training
Percentage of workforce taken Lean
fundamentals
#DIV/0! percentage
6.2 Implementation CI feedback loop 5.0% 100% completed forms
6.3 Process Confirmation #DIV/0!
6.4
Variation/Error Management & Rapid Reaction
System
#DIV/0!
Lean Assessment
Indicator Metric

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Lean Professional Deliverables - Week 4 of 6

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