Blue Hot Stamp and Barcode Machine Issues

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Deliverables Report
Lean Professional® Training Week 3
Name: Brandon Kingcaid

Deliverables Report Lean Professional Training
© Lean Alliance GmbH • All rights reserved • www.lean-alliance.com Page 2
Visual Management – LPMS at Bottleneck
2.3
M/C: _________ Shift: __________ Date: __________
Time Size Goal Actual Reject
Reject
%
Downtime >
5 mins
C/O
5:30 AM 1000 mL 1800 1500 20 1.3% 3 -
7:30 AM 1000 mL 1800 2 -
9:30 AM 1000 mL 1800 4 -
11:30 AM 1000 mL 1800 4 -
1:30 PM 1000 mL 1800 0 -
3:30 PM 1000 mL 1200 750 5 0.7% 1 22 mins
5:30 PM 1000 mL 1800 -
7:30 PM 1000 mL 1800 -
9:30 PM 1000 mL 1800 -
11:30 PM 1000 mL 1800 -
1:30 AM 1000 mL 1800 -
3:30 AM 1000 mL 1800 -
5:30 AM 1000 mL 1800 -
Changeover Target
CS Corner Seal L Leaker
XS Cross Seal F Fill Volume
S2 Station 2 D Dropped Bag
BP Barcode Printer
BHS Blue Hot Stamp
LPMS 1 Board
Codes / Comments
BP, BHS addressed by mechanic. L, F addressed by FFS
attendant
Reject Target Downtime / Reject CodesShift Action Items
Identify root causes of small downtimes < 5 mins
22
mins
1%

Visual Management – LPMS 2 Rolling Area Board
2.3
Front
Back

.
 These lights indicate the status of the line. Green is
running, yellow is ready to start and red is stopped.
 The FFS operators were having trouble seeing these
lights through the tiny window. To improve the situation,
lights were installed inside the primary to indicate that
downstream is ready.
Visual Management – Andon Walk
 The message board displays the date, lot number, lot
quantity and expiration date for each production line.
 Currently, the board is updated by remote to the new lot
information during the changeover.
 A possible improvement would be to have the board
automatically updated when the operator scans the
process order into EBR (Electronic Batch Record).
2.1, 2.4, 4.2

 The main hallway is the path for many forklifts and
pedestrian traffic.
 These overhead lights turn on to indicate to the forklift
drivers that a person is exiting the room.
 A possible improvement would be to add a buzzer to
have both visual and audible indicators.
Visual Management – Andon Walk
 The primary gowning room is a highly regulated GMP
area. There are signs all over to remind people of what
is required to enter into the next room.
 To prevent two doors from being open at the same time,
a possible improvement would be to have an automatic
locking mechanism that allows only one door to open at a
time.
2.1, 2.4, 4.2

 Irvine, CA KPIs
Visual Management - KPI
Most KPIs do not drive Lean behavior
1,2,3,4,5,6
KPI’s for Quarter 1
*PA Jan Feb Mar Q1
Month
Target
Month
Actual
Month’s Performance
Stock Status (%) 1 85% 87% 2% Favorable to Target
Back Order ($000) 1 $300 $414.8 $114.8K Unfavorable to Target
NLR’s (%) 1 5.3% 6.9% 1.6% Unfavorable to Target
PIR’s (DPM) 1 4.0 2.2 1.8 DPM Favorable to Target
Total Inventory (ROC in weeks) 1 13.6 13.2 0.4 weeks Favorable to Target
Cost Savings (reported Quarterly) 3 $0 $225 $225K Favorable to Target
Material Scrap ($000) 1 $236.5 $206.2 $30.3K Favorable to Target
Standard Cost Variance ($000) 2 ($44.3) ($839.2) ($794.8K) Favorable to Target
- PA = Points Available Total Points 5/8 4/8 9/11 18/27
Score 63% 50% 82% 67%
Gainsharing
($000) Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec YTD
MV $34 ($879) ($476) ($1,321)
Irvine Manufacturing Variance (MV) = YTD MV excluding Purchase Price Variance (PPV)

 Suggested KPI’s to Drive Lean Behavior
Visual Management - KPI
Focusing on these Lean metrics will lead to an
increase in quality and decrease in product cost.
KPI’s for Quarter 3
*PA July Aug Sep Q3
Month
Target
Month
Actual
Month’s Performance
Inventory Turns 1
On Time Delivery 1
Overtime 1
OEE 1
Average Kanban Replenishment
Time
1
Cost Savings (reported Quarterly) 3
Material Scrap ($000) 1
Leadtime 2
- PA = Points Available Total Points 8/8
Score 100%
Gainsharing
($000) Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec YTD
MV $34 ($879) ($476) ($1,321)
1,2,3,4,5,6

 OEE for Excel Filling Line
TPM - OEE
A well developed tracking system is
needed to properly calculate OEE and
bring problems to the surface.
2.1,2.3,4.2
Lead:
Plant Operating Time
Shift Length Hours =
Minutes
Planned Shut Down
Minutes Each
Meetings Breaks @ 30
Min Total= 30
Total Planned DT Minutes
Equipment Availability 85.64%
Changeovers Minutes
Sanitization Minutes
Total UnPlanned DT Minutes
Performance (Efficiency) 97.89%
Size 250 mL 500 mL 1000 mL Total
FFS Machine Cycles 19500 19500
Units Transferred 19089 19089
Ther. Output/Min 33.0 33.0 33.0
Theoretical Time
Required @ 100% 0 578 0 578
Speed Loss (Time) Minutes
Quality Rate 97.89%
Total Pieces (Gross) Pieces
Reject Pieces Pieces
Quality Loss (Time) Minutes
Fully Productive Time
OEE Factor My OEE%
Availability 85.64%
Efficiency 97.89%
Quality 97.89%
Overall OEE 82.07%
75.0%
19,500
411
12
92.0%
98.0%
67.6%
578
Target
720
0
12
40
0
99
30
DAY
1
Shift:
#
DAYS Total Time
Available vs. Losses
578
120
99
30
0
50
100
150
200
250
300
350
400
450
500
550
600
650
700
750
Minutes used in
Shift
Minutes
Planned Shutdown
Downtime Loss
Speed Loss
Quality Loss
Day Shift OEE
85.64%
97.89% 97.89%
82.07%80%
90%
100%
Avail. Perf.
Qual. OEE
Quality Rate 97.89%
Total Pieces (Gross) Pieces
Reject Pieces Pieces
Quality Loss (Time) Minutes
OEE Factor My OEE%
Availability 85.64%
Efficiency 97.89%
Quality 97.89%
Overall OEE 82.07%
75.0%
19,500
411
12
92.0%
98.0%
67.6%
578
Target
0
50
100
150
200
250
Minutes used in
Shift
Day Shift OEE
85.64%
97.89% 97.89%
82.07%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
OEE
Avail. Perf.
Qual. OEE
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
OEE
Avail. Effic.
Qual. OEE
We need to improve tracking of our
downtime and primary room rejects.

TPM – Downtime Pareto
More work is needed to further break down the top reason codes
2.1,3.2,4.2

TPM – Downtime Pareto
Some root cause analysis should be done
on why we hit the Overwrap Emergency Stop so often.
2.1,3.2,4.2

 Ask 5 times “Why” for your pareto #1!
TPM – 5 Why?
Downtime reason WHY?
Operator engages the Overwrap E-Stop Fault Overwrap machine is chopping bags
Bags not properly spaced out as the overwrap is
applied
As the overwrap film roll unwinds, the tension does
not remain consistent
The older design overwrap machine has more
variation in its cycles
The overwrap machine on line 7 was never
upgraded
Upgrade the overwrap machine to the newest technology 2.1,3.2,4.2

x y z
Impactontheproductionsystem
PositionintheValeStream
Impactonthecustomer
RANKING
FFS Machine 8 7 4 F
Checkweigher 8 7 4 F
HVLD 8 7 4 F
Overwrap Machine 8 7 4 F
Automated Loader 2 2 1 A
Automated Unloader 2 2 1 A
Case Sealer 3 2 4 A
Robot Palletizer 9 9 4 F
TPM – Machine priority cube
A – Not critical to value stream
Disruptive to production system
Low effect on customer
F – Critical to value stream
Disruptive to production system
Low effect on customer
1,2.1

TPM – Ishikawa Diagram
The analysis shows that we need: 1) A system for tracking label plates / type chase characters
and 2) A system for separating operator / maintenance tasks 2.1,2.4,4.2
MACHINE METHOD /
PROCEDURES
MAN
Handling
Temperature
Humidity (lo, controlled)
Setup
Storage
Heat Plate
Fear of reporting bad print = NLR
Schedule
Water
Settings
Settings
Location
Latch left off of pad drawer (unlocked)
Pad adjustment not done
by qualified personnel
Too much torque applied
to screws on heat plate
Dropping label plates causes damage
Handling label plates carelessly causes damage
Check pad for flatness
when replacing
Adding shims to compensate
for parallelism of worn characters
Screws get stripped
Key inserts missing
Belts Break
Cylinder Leaks Air
Heater not heating sufficiently
RTD malfunction
Foil tracking / Bad bearings
Accuracy
Repeatability
Lack of measure
No measuring when plates /
characters are worn
No measuring how many cycles
a plate has been used
No preventive maintenance / replacement for label plates / characters
Character / type chase storage
Using two pads for backing
Hot Stamp
Barcode
We do not check pad performance when changing
Too many adjustments to blocks / characters (exp, etc)
Shimming with pads has loose tolerances that affect consistency of label quality
Ineffective system for red flagging bad plates
Hot stamp check sheet insufficient
Unit Labeling Failure Modes:
Blue Hot Stamp and
Barcode Machine
ENVIRONMENTMEASUREMENTMATERIALS
Controller
Roller position for pitch
Scanner Position
R-Value
Air Pressure
Gap
Not running label out far enough after lot change
Barcode Settings
Forcing Pieces Together
Hot Stamp can be disengaged while machine is running
Too many small adjustments
Hot stamp belts break too often (right material?)
Dirty plates / type chase characters
Dirty plates / type chase characters
Manual manipulation of film throws
off shift register
Wrinkles in barcode foil
Film wavy on barcode side
Printhead
5
5
5
5
5
5
5
5
5
5
4
4
3
5
5
5
Setup new characters at some frequency
No measure for human
readable quality
5
Dwell time may not allow heat transfer
Solenoid located too far away
E stop causes next cycle no print
Solenoid fails
Barcode ribbon cable issues
Tension on blue foil take up roll
Heater control design
Hot Stamp
Barcode
The enclosure for the unit
controller box heats up
Room not kept at spec temperature
5
5
5
5
5
5
3
5
No optimum sequence for replacing parts/screws
Procedure says to make a test label after each adjustment
Insufficient PM for hot stamp belts
Forcing Pieces Together
5
Too many small adjustments
Check bag label at some frequency

 Videotape Changeover
 Decompose Video
 Analyze Work Content
 Internal
 External
 Non-Value-Added
 Identify Opportunities
Technical Planning – Primary / Overwrap SMED
3.2

Technical Planning - SMED
During optimum staffing levels, an extra operator can assist with
primary changeovers, thereby reducing the changeover time by 23%
Primary Changeover
40RESOURCE 4 32128
OPERATION TIME (15 SEC)
9288 9652 76 80 84
Machine
16 20 7264 686024 28 36
QC - Primary
QC - Primary
RESOURCE 72
Machine
FFS Operator
16 20
FFS Operator
60 64 6828 36 404 8 12 9244 48 56 76 80 84 8824
100
20 mins 25 mins15 mins10 mins5 mins
44 48 56
FFS HELPER
96 100
5 mins 10 mins 15 mins 20 mins 25 mins
5232
3.2

Overwrap Changeover
HDH HELPER 1
25 mins
523224
5 mins 10 mins 15 mins 20 mins
15 mins10 mins5 mins
44 48 56
88
100
20 mins 25 mins
96 1004 8 12 9244 48 56 76 80 8464 6828 36 40
QC - Overwrap
QC
RESOURCE 72
Machine 1
HDH Operator 1
16 20 60
Machine 1
16 20 7264 686024 28 36 40 9288 9652 76 80 84RESOURCE 4 32128
HDH Operator 2
HDH Operator 2
HDH HELPER 2
Machine 2
Machine 2
HDH Operator 1
When the line is down, the employees that manually load bags
onto trays can be further utilized to assist in changeover activities. 3.2

 The overwrap film roll on this line can be changed out
WHILE the line is still running.
 The red hot stamp foil on this line can be changed out
WHILE the line is still running.
3.2

 Previously, when the packing line was changed to a
different size, the mechanic needed to loosen 2 screws
to make the adjustment.
 This button in the automated trayloader disengages the
loaded pallet and allows the new pallet to be loaded
 It was improved by adding an ergonomic twist locking
mechanism.
3.2

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

Contact us!
Lean Alliance® GmbH
Im Schlosshof 4a • D-82229 Seefeld • Germany • Tel: +49 (08152) 7944-94• Fax: +49 (08152) 7944-93
Lean Alliance Inc.
5750 New King Street, Suite 200 • Troy, Michigan, 48098-2611 • U.S.A.

Blue Hot Stamp and Barcode Machine Issues

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