Professional Documents
Culture Documents
Tool
Quality
Goal
Description of Approach
Pareto Analysis
Reduce
Variation
VOC:
understand
Assess each element of a safety checklist
requirement
Safety Checklist
to determine whether corrective or
s that are
preventive action is needed.
critical to
safety
Pie Chart
Reduce
Variation
OPCP
Reduce
Variation
FMEA
Reduce
Variation
Injection Molding
Machining
VDGRARS
Reduce
Variation
Cpk Calculation
Reduce
Variation
Tool Reference
The following Six Sigma tools were used to analyze the business conditions of Chilco to determine methods of reducing variation
and also to determine which areas were in need of attention first. The Six Sigma tools used were Pareto Analysis (LSQTT Tool
#11), Safety Checklist (LSSQTT #11), Pie Chart (LSSQTT #11), OPCP (LSSQTT Tool #12), FMEA (LSSQTT Tool #10), Cpk
Calculation (LSSQTT Tool #12), and Variable Gage R&R Study and Injection Molding studies. These tools were helpful in
determining where to look for problems and which problems were most important to resolve first.
ROL Reference
Levinson, W. (1994, December). Multiple attribute control charts. Quality, 33(12), 10-11.
Bouti, Abdelkader. Ait Kadi, Doud STATE-OF-THE-ART REVIEW OF FMEA/FMECA International Journal of Reliability, Quality
and Safety Engineering, Vol. 1, No. 4 (1994) 515-543
Harpster, R. (2005, April). Demystifying design FMEAs. Quality, 44(4), 20-21.
Stamatis, D.H. Failure Mode Effect Analysis: FMEA from Theory to Execution. Milwaukee, WI: ASQ Quality Press, 2003, pp. 129154.
Chen, Y., Liu, J. (1999). Cost-effective design for injection molding. Robotics and Computer-Integrated Manufacturing, Volume 15,
issue 1. p. 1-21.
Smith, Alice E. Predicting product quality with backpropagation: A thermoplastic injection molding case study. The International
Journal of Advanced Manufacturing Technology. 14 May 1992
Collins, C. (1999). Monitoring cavity pressure perfects injection molding. Assembly Automation, 19(3), 19-20. Courington, S.
(2005). Using In-Mold Impedance Sensors to Control Thermoset Plastic Molding. SME Technical Paper.
Collins, C. (1999). Monitoring cavity pressure perfects injection molding. Assembly Automation, 19(3), 19-20. Courington, S.
(2005). Using In-Mold Impedance Sensors to Control Thermoset Plastic Molding. SME Technical Paper.
Return to 5.0
Attributes
Gapping
Mold Flash
# of Total
Occurences
% of Total
Occurrence
26334
37%
9964
14%
8541
12%
Warpage
6406
9%
Excessive Shrinkage
2847
4%
37%
% of Total Occure n
37%
35%
30%
Mould Sticking
2847
4%
Brittleness
2135
3%
Low Gloss
2135
3%
20%
Un-melted Granules
1779
2.50%
15%
Weak Weldiness
1423
2%
Wrinkles
1068
1.50%
Brown Stains
712
1%
Burn Marks
712
1%
Discoloration
712
1%
Drooling
356
1%
Short Shot
712
1%
Sinks / Voids
712
1%
712
1%
356
1%
Odor
356
0.50%
Screw Slippage
356
0.50%
25%
14%
12%
2%
1%
1%
1%
1%
1%
1%
1%
1%
1%
1%
Sinks / Voids
Odor
Screw Slippage
2%
Short Shot
3%
Drooling
3%
Discolorat ion
3%
Burn Marks
4%
Brown St ains
4%
5%
W rinkles
9%
10%
W eak W eldiness
Un-melt ed Granules
Low Gloss
Brit t leness
Mould St icking
Excessive Shrinkage
W arpage
Mold Flash
Gapping
0%
Attributes
Return to 5.0
Fractured Thermoforms
Weak Weldiness
Discoloration
# of Total
Occurences
% of Total
Occurrence
24617
93%
1324
5%
529
2%
Attributes
100%
90%
80%
70%
60%
50%
93%
% of Total Occurence
93%
90%
80%
70%
60%
50%
40%
30%
20%
10%
5%
2%
Attributes
% of Total
Occurrence
132115
43%
Poor finish
60313
21%
Burrs
45953
16%
50%
Stress cracking
25849
9%
45%
Out of tolerance
40%
35%
ce
Attributes
30%
43%
Discoloration
Weak Weldiness
Fractured T hermoforms
0%
6%
40%
Discoloration
11488
4%
35%
2872
1%
30%
25%
21%
20%
16%
15%
9%
10%
6%
5%
4%
1%
Attributes
Materials
Discoloration
Improper handling
Stress cracking
Burrs
P oor finish
0%
Out of tolerance
Materials
Improper handling
43%
1%
1%
1%
Materials
1%
OK
Not
Not
Safe
App.
General Safety
Actual Site
Good Housekeeping/Cleanliness
Piling and Storage/Tagging Systems
Aisles, Walkways, and Exists
Tools And Supplies
Ladders And Stairs
Machinery And Equipment
Floors, Platforms, and Railings
Electrical Fixtures/Equipment
Dust, Ventilation, and Explosives
Overhead Valves, Pipes, Markings
Protective Clothing/Equipment
Washroom, Lockers, Shower, Deluge
Unsafe Practices/Horseplay/SOPs
First Aid Facilities
Vehicles, Hand and Power Trucks
Fire Fighting Equipment
Guards And Safety Devices
Lighting, Work Tables/Areas
General Maintenance
Safety Training, Communication
Company/OSHA Standards Comply
Cranes, Hoists, Conveyors
Scrap And Rubbish
Other Items, Circumstances
Machinery Inspection
Hydraulic Cylinders
Toggle Machine Linkage
Plates
Safety Bars
Screw Drives
Barrel and Front End
Explanations/ Action/Other
Hoses
Piping
Hydraulic Leaks
Safety Gate
Rear Guard
Fixed Guards
Top Guards
Safety Procedures
Environmental problems
Hazardous and dangerous conditions
Equipment safety procedures and devices
Hazardous materials handling
Unplanned shutdown
Evacuation
First Aid
Fire
Lockout/Tagout
Reporting accidents and spills
Housekeeping
Job safety review and checklist
Hazard Communication Standard
Personal protective equipment
Safety regulations and requirements
Safe use of material handling equipment
Personal protective equipment
Return to 5.0
% Frequency
37%
14%
12%
9%
4%
4%
3%
3%
3%
2%
Wrinkles
Brown Stains
Burn Marks
Discoloration
Drooling
Short Shot
Sinks/Voids
Streaks/Splash
Marks
Flow Marks/Jetting
Odor
Screw Slippage
1068
712
712
712
356
712
712
712
356
356
356
2%
1%
1%
1%
1%
1%
1%
1%
1%
1%
1%
Clinton Plant
Number of
Attributes/Defect
Products with the
s
Defect
Fractured
24617
Thermoforms
% Frequency
93%
Weak Weldiness
Discoloration
1324
529
5%
2%
Fractured Thermoforms
93%
Beijing Plant
Number of
Attributes/Defect
Products with the
s
Defect
Out of tolerance
132115
Poor finish
60313
Burrs
45953
Stress cracking
25849
Improper handling
17232
Discoloration
11488
Materials
2872
% Frequency
45%
20%
16%
9%
6%
4%
1%
Discoloration Materials
Improper handling
1%
4%
6%
Stress cracking Out of tolerance
45%
Discoloration Materials
Improper handling
1%
4%
6%
Out
of
tolerance
Stress cracking
45%
9%
Burrs
16% Poor finish
20%
Return to 5.0
Customer:
Prototype
Page 1 of 1
Pre- Launch
Production
Key Contact/Phone:
Date(Original):
Mike Carper
2006-12345
6-Jan-05
Core Team:
12-Apr-06
682
BGSU 5678
Part Name/Description:
5/20/2006
Supplier/Plant Approval/Date:
6/1/2006
6/1/2006
ABC Housing
Supplier/Plant:
Date(Revision):
Supplier Code:
Other Approval/Date:
Other Approval/Date:
GBO 789
GBO
Part
Process
Number
Process Name/
Operation description
Receiving
Machine, Device,
Jig, Tools.
Characteristics
For Mfg.
No
Receiving Dock
Product
Special
Char.
Product/Process
Methods
Evaluation Measurement
Process
Class
Specification/Tolerances
Technique
Size
Frequency
Receipt &
Quantity, delivery
Visual
All
Visual
All
Verification
& damage.
Storage
Sample
Control
Method
Reaction Plan
Per Lot #
Certified vendors,
SOP certify receipts
Reconcile packing
slips with PO and
Per Lot
invoices
2
Warehouse
Bruno Press
Relocation to
Machine
4&5
Machining &
Injection
Bruno Press
Length
FIFO
759.4 mm
+/- 5.0mm
Visual
All
Per Lot
Tape measure
1 piece
per cavity
Establish procedures
& work Instructions
Provide forklift training
for materials handlers
SOP to review mat'l
prior to use
Barcode router &
scan at machine to
6&7
Packaging &
Bruno Press
Width
Labeling
539.9 mm
+/- 5.0mm
"
"
Visual / Counting
All
"
amount of parts
2
Label information
Relocation to
Per
Re-Count &
Order
Re-Pack Parts.
"
"
"
Trending of errors
"
Visual
All
Per Lot
Training
Supervisor. Initiate
and quantity
8
Warehouse
FIFO
Storage
Change label to
reflect the proper
information.
Warehouse
"
Visual
All
Per Lot
a corrective action.
corrective action.
10
Dock Audit
Shipping Dock
11
Ship to Customer
Shipping Dock
Overall condition of
parts, labels, cartons,
amounts etc.
Part Verification
Part delivered to
the customer
"
Label
Mapics tracking
system.
100%
All
Orders
Dock Audit
check sheet.
Auditor breaks
"
Isolate order.
Hold for 100%
inspection.
"
Corrective action.
Notify customer.
Return to 5.0
Potential
Failure Mode and Effects Analysis
(PROCESS FMEA)
N/A
S. Stamm, M. Carper
POTENTIAL FAILURE
MODE
EFFECTS OF FAILURE
S
E
V
C
L
A
S
S
FMEA Number:
IJ-001
Process Responsibility:
Prepared by:
S. Stamm
Key Date:
June 2, 2007
CURRENT CONTROLS
Prevention
CURRENT CONTROLS
Detection
D
E
T
R
P
N
RECOMMENDED
ACTION
Vendor problem/comm.
Receiving Insp.
35 None
Vendor problem/comm.
Receiving Insp.
32 None
Vendor or communication
problem
21 None
-No Mat'l
certification.
Vendor problem
Receiving Insp.
-Receiving Insp.
-Possible production
Receiving resources
behind schedule.
Damaged Mat'l
shutdown
Damaged mat'l used in mfg.
63 SOP requiring no
receipt of mat'l without
certification.
10 None
Lack of Training/Awareness
Training
Lost Mat'l
Production Interruption
Training/Storage Capacity
3 MOVE
Raw Material
Damaged Mat'l
Lack of Training/Awareness
4 INJECTION
Flash
Mold misalignment
1 RECEIVING
2 STORE
Raw Material
- Receive wrong
material.
ACTION TAKEN
12
12
Visual Inspection
20 None
12 None
1 PM for mold
Visual Inspection
12 None
Nozzle blockage
14 None
28 None
14 None
None
SOP proposed.
Mold Flash
SOP proposed.
Rough Surfaces /
Orange Peel
Visually unappealing.
Excess moisture.
2 Check humidity.
Warpage
Warped part.
Anisotropic Shrinkage
Excessive Shrinkage
Incomplete part.
Insufficient mataerial.
None
6/12/2007
Mould Sticking
Mold misalignment.
18 None
6/12/2007
Page 22 of 42
Visual inspection.
R
P
N
D
E
T
1 14
O
C
C
Gapping
S
E
V
MOLDING
Short Shots
6/2/2007 (Rev.) 01
RESP. COMP.
DATE
Potential
Failure Mode and Effects Analysis
(PROCESS FMEA)
N/A
S. Stamm, M. Carper
POTENTIAL FAILURE
MODE
EFFECTS OF FAILURE
S
E
V
IJ-001
Prepared by:
S. Stamm
Key Date:
June 2, 2007
CURRENT CONTROLS
Prevention
CURRENT CONTROLS
Detection
D
E
T
R
P
N
RECOMMENDED
ACTION
6/2/2007 (Rev.) 01
RESP. COMP.
DATE
ACTION TAKEN
Vendor error.
1 Vendor support.
Hardness testing.
10 None
6/12/2007
Excess moisture.
2 Check humidity.
Visual inspection.
24 None
6/12/2007
Incomplete part.
Insufficient temperature.
None
6/12/2007
Weak Weldiness
Incomplete part.
Insufficient mataerial.
None
6/12/2007
Wrinkles
Mold misalignment.
18 None
6/12/2007
Brown Stains
Visually unappealing.
2 Check humidity.
Visual inspection.
24 None
6/12/2007
Burn Marks
Visually unappealing.
Excess air.
24 None
6/12/2007
Discoloration
Visually unappealing.
Fluid contamination.
24 None
6/12/2007
Drooling
Visually unappealing.
Excess air.
24 None
6/12/2007
Short Shot
Incomplete part.
Insufficient mataerial.
None
6/12/2007
Sinks / Voids
Incomplete part.
Insufficient mataerial.
None
6/12/2007
Visually unappealing.
Visual inspection.
24 None
6/12/2007
Visually unappealing.
Irregular melting.
Visual inspection.
24 None
6/12/2007
Odor
Part failure.
Excess temperature.
Smell check.
18 None
6/12/2007
Screw Slippage
Incomplete part.
Insufficient mataerial.
6/12/2007
Insp. Fatigue/Boredom
3 Insp. Breaks
28 None
14 None
Brittleness
Unacceptable product.
Low Gloss
Visually unappealing.
Un-melted Granules
10
C
L
A
S
S
FMEA Number:
Process Responsibility:
None
S
E
V
O
C
C
D
E
T
R
P
N
5 INSPECTION
6 PACKAGING
7 LABELING
Gage out of
calibration
24 None
24 None
Customer aggravation
20 None
Page 23 of 42
2 28
Potential
Failure Mode and Effects Analysis
(PROCESS FMEA)
8 MOVE
Finished Goods
9 STORE
Finished Goods
10 DOCK AUDIT
N/A
S. Stamm, M. Carper
POTENTIAL FAILURE
MODE
EFFECTS OF FAILURE
S
E
V
IJ-001
Prepared by:
S. Stamm
Key Date:
June 2, 2007
CURRENT CONTROLS
Prevention
CURRENT CONTROLS
Detection
D
E
T
R
P
N
RECOMMENDED
ACTION
6/2/2007 (Rev.) 01
RESP. COMP.
DATE
ACTION TAKEN
Labeling error
Customer aggravation
12 None
Loss of traceability
Damaged mat'l gets to customer
6
7
Damaged Mat'l
Training
3
6
Damaged Mat'l
Lost mat'l
Monthly inventory of
storage location by scans
18 None
126 SOP requiring Oper.
6/5/2007 SOP complete
review of package at dock audit
and approved
126 SOP requiring Oper.
6/5/2007 SOP complete
review of package at dock audit
and approved
18 None
Customer aggravation
Auditor breaks
12 None
correctly filled
11 SHIPPING
C
L
A
S
S
FMEA Number:
Process Responsibility:
Late delivery
Early delivery
S
E
V
O
C
C
D
E
T
R
P
N
14
14
needing re-training
Custom aggravation and potential
downtime
36 None
Carrier problems
Carrier audits
12 None
- Loading instructions,
90 Router software
12/31/2007
changes to notify Prod. Ctrl.
of potential late deliveries
Routing mishap
Return to 5.0
Tool Reference
One of the tools of use for documenting and promoting innovation is the Failure Mode and Effects Analysis (FMEA) tool. The use of FMEA promotes a total system
approach, as discussed in LSSQTT Tool #7 Assessing Technological Infrastructure For Innovation, with the focus on preventive systems, with FMEA linked to a PDCA cycle.
More details and direction were found in LSSQTT Tool #10 Robust Design For New Product Development, Innovation, with topics 4 and 5 focusing specifically on FMEA.
The utility of using FMEA to identify problems before they occur is identified, as well as FMEAs use as a design, process analysis or product improvement tool with a number
of broader issues identified. The steps, procedures and broader innovation relationships are identified, which were necessary to understand in order to utilize the FMEA tool
to analyze Chilco problems. In Tool #9 and #10 FMEA is used on 1) Attributes for Greensboro - Injection Molding; 2) Attributes Identified for Clinton Packaging, and 3)
Attributes Identified for Manchurian Machining; which also incorporated criteria for risk mitigation and used input from a Pareto analysis. It is also possible to link FMEA to a
Quality Function Deployment (QFD) process, and other problem solving and suggestion systems, such as SOP, OPCP, and others. LSSQTT Tool #11 also provides insight
into using FMEA, framed as a formalized technique and process whereby cross functional teams of technical persons can assess product and process systems to assure
that failure in components or elements have been addressed, and hopefully, prevented. LSSQTT Tool #12 ISO 9000 Foundational Infrastructure For Management,
Assessment, and Decision Making To Standardize Improvement provided insight into the utility of FMEA for quality systems.
ROL Reference
Bouti, A. & Ait Kadi, D.(1994). STATE-OF-THE-ART REVIEW OF FMEA/FMECA. International Journal of Reliability, Quality and Safety Engineering, 1(4), 515-543.
Harpster, R. (2005). Demystifying Design FMEAs. Quality, 44(4), 20.
Lee, P. S., Plumlee, B., Rymer, T. Schwabe, R., & Hansen, J. (2004). Using FMEA to Develop Alternatives to Batch Testing. Retrieved June 24, 2007 from
http://www.devicelink.com/mddi/archive/04/01/018.html
Stamatis, D.H. Failure Mode Effect Analysis: FMEA from Theory to Execution. Milwaukee, WI: ASQ Quality Press, 2003, pp. 129-154.
Page 24 of 42
None
Quality Function Deployment (QFD) process, and other problem solving and suggestion systems, such as SOP, OPCP, and others. LSSQTT Tool #11 also provides insight
into using FMEA, framed as a formalized technique and process whereby cross functional teams of technical persons can assess product and process systems to assure
that failure in components or elements have been addressed, and hopefully, prevented. LSSQTT Tool #12 ISO 9000 Foundational Infrastructure For Management,
Assessment, and Decision Making To Standardize Improvement provided insight into the utility of FMEA for quality systems.
Potential
Failure Mode and Effects Analysis
ROL Reference
(PROCESS FMEA)
5.5
FMEA
- INJECTION
MOLDING
Bouti,
A. & Ait
Kadi, D.(1994). STATE-OF-THE-ART
REVIEW OF FMEA/FMECA. International Journal of Reliability, Quality and Safety Engineering, 1(4), 515-543.
Item:
FMEA Number:
IJ-001
Process Responsibility:
Prepared by:
S. Stamm
Key Date:
June 2, 2007
N/A
Lee, P. S., Plumlee, B., Rymer, T. Schwabe, R., & Hansen, J. (2004). Using FMEA to Develop Alternatives to Batch Testing. Retrieved June 24, 2007 from
S. Stamm, M. Carper
Core
Team:
http://www.devicelink.com/mddi/archive/04/01/018.html
PROCESS
DESCRIPTION
Stamatis,
D.H.
POTENTIAL FAILURE
MODE
Failure Mode
Effect Analysis:
EFFECTS OF FAILURE
S
C POTENTIAL CAUSES OF FAILURE O
E Milwaukee,
L
Execution.
WI: ASQ Quality Press,C2003,
V
A
C
S
S
CURRENT CONTROLS
Prevention
pp. 129-154.
Page 25 of 42
CURRENT CONTROLS
Detection
D
E
T
R
P
N
RECOMMENDED
ACTION
6/2/2007 (Rev.) 01
RESP. COMP.
DATE
ACTION TAKEN
S
E
V
O
C
C
D
E
T
R
P
N
Machining Operation
1 RECEIVING
2 STORE
Raw Material
N/A
EFFECTS OF FAILURE
S
E
V
-No Mat'l
certification.
-Receiving Insp.
behind schedule.
-Possible production
shutdown
Damaged Mat'l
Lost Mat'l
Production Interruption
9
8
8
8
8
8
8
Dimension
specifications. Customer
rejection.
- Receive wrong
material.
3 MOVE
Damaged Mat'l
Raw Material & finished
4 MACHINING Manchurian
attributes
Out of tolerance
Poor finish
Burrs
Stress cracking
Improper handling
Discoloration
Materials
5 INSPECTION
C
L
A
S
S
specifications. Customer
rejection.
Will not meet customers
specifications. Customer
rejection.
Gage out of
calibration
Wrong part is
produced / wrong
amount of parts.
Customer rejection.
Customer may not have
enough to fill orders.
7 LABELING
8 MOVE
Finished Goods
9 STORE
Finished Goods
in container
8
6
compromised
Increased shipping and production
costs
Customer aggravation
Labeling error
Customer aggravation
Damaged Mat'l
Loss of traceability
Damaged mat'l gets to customer
6
7
Damaged Mat'l
Lost mat'l
10 DOCK AUDIT
Customer aggravation
correctly filled
11 SHIPPING
Late delivery
Early delivery
Return to 5.0
Tool Reference
One of the tools of use for documenting and promoting innovation is the Failure
Mode and Effects Analysis (FMEA) tool. The use of FMEA promotes a total
system approach, as discussed in LSSQTT Tool #7 Assessing Technological
Infrastructure For Innovation, with the focus on preventive systems, with FMEA
linked to a PDCA cycle. More details and direction were found in LSSQTT Tool
#10 Robust Design For New Product Development, Innovation, with topics 4 and
5 focusing specifically on FMEA. The utility of using FMEA to identify problems
before they occur is identified, as well as FMEAs use as a design, process
analysis or product improvement tool with a number of broader issues identified.
The steps, procedures and broader innovation relationships are identified, which
were necessary to understand in order to utilize the FMEA tool to analyze Chilco
problems. In Tool #9 and #10 FMEA is used on 1) Attributes for Greensboro Injection Molding; 2) Attributes Identified for Clinton Packaging, and 3) Attributes
Identified for Manchurian Machining; which also incorporated criteria for risk
mitigation and used input from a Pareto analysis. It is also possible to link FMEA
to a Quality Function Deployment (QFD) process, and other problem solving and
suggestion systems, such as SOP, OPCP, and others. LSSQTT Tool #11 also
provides insight into using FMEA, framed as a formalized technique and process
whereby cross functional teams of technical persons can assess product and
process systems to assure that failure in components or elements have been
addressed, and hopefully, prevented. LSSQTT Tool #12 ISO 9000 Foundational
Infrastructure For Management, Assessment, and Decision Making To
Standardize Improvement provided insight into the utility of FMEA for quality
systems.
ROL Reference
Bouti, A. & Ait Kadi, D.(1994). STATE-OF-THE-ART REVIEW OF FMEA/FMECA.
International Journal of Reliability, Quality and Safety Engineering, 1(4), 515-543.
Harpster, R. (2005). Demystifying Design FMEAs. Quality, 44(4), 20.
Lee, P. S., Plumlee, B., Rymer, T. Schwabe, R., & Hansen, J. (2004). Using FMEA
to Develop Alternatives to Batch Testing. Retrieved June 24, 2007 from
http://www.devicelink.com/mddi/archive/04/01/018.html
Stamatis, D.H. Failure Mode Effect Analysis: FMEA from Theory to Execution.
Milwaukee, WI: ASQ Quality Press, 2003, pp. 129-154.
Process Responsibility:
Manchurian Prod.
Key Date:
June 2, 2007
POTENTIAL CAUSES OF
FAILURE
O
C
C
CURRENT CONTROLS
Prevention
CURRENT CONTROLS
Detection
D
E
T
R
P
N
Vendor problem/comm.
Receiving Insp.
16
Vendor problem/comm.
Receiving Insp.
32
Vendor or communication
problem
Receiving Insp.
21
Vendor problem
Receiving Insp.
63
Overtime
10
Lack of Training/Awareness
Training
108
Training/Storage Capacity
Inventory expediter
10
Lack of Training/Awareness
Training
108
Improper set-up /
operator in hurry
O-ring failure; PM issue
Improper set-up /
operator in hurry
Improper set-up /
operator in hurry
1
2
2
2
1
1
1
training
training
training
training
training
training
training
Set-Up Sheet
Final process steps
Final process steps
Final process steps
Final process steps
Final process steps
Final process steps
3
2
2
2
2
2
3
27
32
32
32
16
16
24
54
fixturing
Inspection at Operation
Set-Up Sheet
Inspection at Operation
Material variation
Dull tooling
Bad tooling
14
32
14
14
1 Production order/router
system in place
56
1 Training.
14
Vendor error.
Vendor error.
1
2
8
12
Trending of errors
Packaging technician error
24
20
12
Training
18
126
126
Monthly inventory of
storage location by scans
18
Auditor breaks
12
36
Carrier problems
Carrier audits
12
- Loading instructions,
90
Routing mishap
needing re-training
FMEA Number:
M-001
Prepared by:
M. Chandler
6/4/2007 (Rev.) 01
RESP. COMP.
DATE
ACTION TAKEN
S
E
V
O
C
C
D
E
T
R
P
N
None
None
None
1 14
12
12
SOP requiring no
receipt of mat'l without certification
None
Schedule PM
Schedule PM
Schedule PM
Schedule PM
Schedule PM
Schedule PM
Schedule PM
###
###
###
###
###
###
###
12/31/2007
scan at machine to
load correct program
None
None
None
None
2 14
14
14
None
Track as PM.
Track as PM.
None
None
None
None
SOP requiring Oper.
6/5/2007
review of package at dock audit
SOP requiring Oper.
6/5/2007
review of package at dock audit
None
None
None
None
Router software
12/31/2007
changes to notify Prod. Ctrl.
of potential late deliveries
None
Return Home
Return Home
This is a variable gage R&R study of the "lip" dimension of Chilco part number
81550/60-00040-00.
Inspection Description:
This dimension is measured with digital calipers by a certified operator. This is
an in-process inspection done by the injection molding operators after injection
molding and after the part has cooled for 30 minutes.
Operation:
Characteristic:
Charts Used:
Gage/Device:
Tolerance: 0.02
Return to 5.0
38
1
2
3
4
5
6
7
8
9
Trial 1
0.497
0.501
0.547
0.545
0.791
0.786
0.874
0.831
0.689
10
0.642
Sample ID
Trial 1
Trial Averages
Trial 2
0.499
0.496
0.543
0.548
0.789
0.786
0.878
0.833
0.69
Operator B
Operator C
Trial 3
Range
Trial 1
Trial 2
Trial 3
Range
Trial 1
Trial 2
Trial 3
Range
0.498
0.496
0.546
0.547
0.788
0.786
0.879
0.833
0.688
0.002
0.004
0.003
0.003
0.002
0.001
0.004
0.002
0.002
0.495
0.493
0.542
0.544
0.785
0.786
0.874
0.832
0.688
0.495
0.495
0.542
0.545
0.785
0.785
0.875
0.829
0.687
0.496
0.494
0.542
0.544
0.786
0.785
0.874
0.831
0.689
0.001
0.002
0.000
0.001
0.001
0.001
0.001
0.003
0.002
0.495
0.495
0.543
0.544
0.783
0.784
0.874
0.828
0.688
0.495
0.494
0.542
0.543
0.784
0.784
0.874
0.83
0.687
0.495
0.495
0.542
0.543
0.784
0.784
0.874
0.829
0.688
0.000
0.001
0.001
0.001
0.001
0.000
0.000
0.002
0.001
0.641
0.64
0.64
Trial 2
Trial 3
Trial 1
0.670
R Average:
0.002
Minimum Operator: 0.667
Maximum Operator: 0.670
Difference:
0.003
Number of Operators ( 3
No. of Trials (n):
3
Trial 2
Trial 3
Trial 1
Trial 2
0.64 0.000
Trial 3
RA
Operator B
RB
Operator C
RC
0.003
0.668
D4:
0.001
0.667
0.001
2.58
K1:
3.05
K2:
2.7
Tolerance:
Return to 5.0
39
0.02
Calculations:
Calculate UCL R
UCL R=
R Average * D4
0.004
Calculate Equipment Variation (EV) where:
EV = ( R Avg) (K1)
EV= 0.005
AV =
0.007
% AV= 59.80
Calculate % R & R Where:
% R&R= ( % EV) + (% AV)
% R&R=
64.3
40
33.58
33.49
34.18
35.28
34.52
34.35
33.92
Run Chart
40
Value
Point #
35.4
34.14
10
34.12
11
35.87
12
33.9
13
34.64
14
34.58
15
35.36
Upper Spec
36.4
Mean
34.513
16
34.08
Lower Spec
29.8
Variance
0.41515
StDev.
0.644
Center Spec
539.9
Cp
2.59
Tolerance
5.0
Cpk
0.97
17
33.9
18
35.14
19
34.62
20
34.01
21
35.62
22
35.17
23
33.98
24
34.74
25
33.8
26
35.24
27
34.5
28
35.11
29
34
30
1 2 3 4 5 6 7 8 9 101112131415161718192021222324252627282930
Data Point
This capability analysis was for the weight, in milligrams, of Chilco part
#81550/60-00040-00. The weight of the part needs to be between 29.8
and 36.4 mg. Clearly we are capable (Cp of 2.59) but the process needs to
be re-centered as we are running on the high side of the specification
limits. The Cpk could be improved by re-centering the process.
Page 41
30
34.14
This capability analysis was for the weight, in milligrams, of Chilco part
#81550/60-00040-00. The weight of the part needs to be between 29.8
5.10
Cpk
Calculation
and 36.4 mg. Clearly we
are
capable
(Cp of 2.59) but the process needs to
be re-centered as we are running on the high side of the specification
limits. The Cpk could be improved by re-centering the process.
Return to 5.0
Page 42