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5.

0 SIX SIGMA ANALYSIS


Through the Six Sigma analysis, the team aims to understand the sources of variation with the processes within the company
and relate those to productivity and profitability. There are three types of information presented in this section:

Tool

Quality
Goal

Description of Approach

Description of Intended Outcomes

Pareto Analysis

Reduce
Variation

Record most frequently occurring issues


contributing to increased variation at each
of the sites.

Identify which problems to use other Six


Sigma tools on first to achieve desired
quality outcome.

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

Identify line items where critical to safety


requirements may not be met.

Pie Chart

Reduce
Variation

Record most frequently occurring issues


contributing to increased variation at each
of the sites.

OPCP

Reduce
Variation

Understand how variation is controlled at


Record processes, control mechanisms, and each stage of the production process.
policies to reestablish control.
Understand what policies are already in
place for corrective action.

FMEA

Reduce
Variation

Record all possible locations at which


deviations from specifications within the
process can occur.

Understand where the most failure prone


parts of the process are.

Provides FMEA on injection molding


operations.
Provides FMEA on machining operations.

Injection Molding
Machining
VDGRARS

Identify which problems to use other Six


Sigma tools on first to achieve desired
quality outcome.

Reduce
Variation

Conduct Gage R&R on lip.

Understand whether there is an issue with


one part in the process, highlighted by
previous analysis as a potential source of
more variability.

Cpk Calculation

Reduce
Variation

Evaluate process capability for one part in


Chilco production process.

Determine whether process needs to be


adjusted.

Note: Click on blue links above to view worksheet.

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.

5.1 PARETO CHARTING


Pareto charting is often done early in analyses, piggy-backed on histograms and other preliminary data collection and problem
identification. It is used to show areas needing attention versus those we can postpone. Thus, it is a good decision tool in trying to get
to the root of the problem associated with a characteristic or attribute which is indicating a defect or defective. General shape of the
chart is constant but, the frequency and the % values shift to present relationships inherent in the facts being shown.

5.1.1 General Directions.


Identify the problems or attribute to study. Collect data and frequency of the attributes. List the attributes in the table in descending
order, with those with the highest frequency on the top and the least at the bottom. The percentage of total occurrence for each
attribute relative to the total of all occurences will be automatically calculated in the third column. This will automatically generate a
pareto chart with the percentage frequency listed on the vertical axis and the attributes listed in the horizontal axis. Each column
represents individual attributes and is shaded with a different color. The % frequency is generally not 100%, since in fact, it is very
unlikely that any set of occurrences would ever equal 100%.

5.1.2 Attribute Table.


The following table lists the data on problems reported from the three plants of Chico, Inc. The most frequent problem areas are
identified and their frequency of occurrence are tabulated in decreasing order. The frequency is listed according to the percent of total
occurrence reported due to the corresponding attribute. The attribute with the highest frequency was the major culprit in quality
issues during the year 2006, and thus, is likely the area to attack first for improvement, with other areas following in decreasing order.
A graphical analysis of the relationship between individual attributes is shown in the pareto charts below. Three charts are shown, one
for The Greensboro Injection Molding facility, and one for the Clinton Packaging Plant, and one for the Manchurian Machining plant.

Return to 5.0

Attributes
Gapping
Mold Flash

# of Total
Occurences

% of Total
Occurrence

26334

37%

9964

14%

Rough Surfaces / Orange Peel

8541

12%

Warpage

6406

9%

Excessive Shrinkage

2847

4%

% of Total Occure nce

Attributes Identified, Frequency, % Occurrence. Greensboro - Injection Molding

1.4.4 Pareto Chart - Greensboro Quality Issues


40%
35%
30%
25%
20%

37%

% of Total Occure n

1.4.4 Pareto Chart - Greensboro Quality Issues


40%

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%

Streaks / Splash Marks

712

1%

Flow Marks / Jetting

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

St reaks / Splash Marks

Flow Marks / Jet t ing

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

Rough Surfaces / Orange P eel

Mold Flash

Gapping

0%

Attributes

Return to 5.0

Attributes Identified, Frequency, % Occurrence. Clinton - Packaging

Fractured Thermoforms
Weak Weldiness
Discoloration

# of Total
Occurences

% of Total
Occurrence

24617

93%

1324

5%

529

2%

1.4.4 Pareto Chart - Clinton Quality Issues


% of Total Occurence

Attributes

100%
90%
80%
70%
60%
50%

93%

% of Total Occurence

1.4.4 Pareto Chart - Clinton Quality Issues


100%

93%

90%
80%
70%
60%
50%
40%
30%
20%
10%

5%

2%

Attributes

Attributes Identified, Frequency, % Occurrence. Manchurian - Machining


# of Total
Occurences

% of Total
Occurrence

132115

43%

Poor finish

60313

21%

Burrs

45953

16%

50%

Stress cracking

25849

9%

45%

Out of tolerance

1.4.4 Pareto chart - M anchurian Quality Issues

40%
35%

ce

Attributes

30%

43%

Discoloration

Weak Weldiness

Fractured T hermoforms

0%

1.4.4 Pareto chart - M anchurian Quality Issues


50%
45%
17232

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

% of Total Occure nce

Improper handling

43%

1%
1%
1%

Flow Marks / Jet t ing


Odor
Screw Slippage

Materials

1%

5.2 SAFETY INSPECTION CHECKLIST


Checklist Item

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

5.3 PIE CHART


Pie Chart is a graphical representation of the defects or areas needing improvement in a process. The chart shows 100
product defects by categories, sorted and organized within the pie chart by count and percentage. This analytical tool is a
simple "slice out of the pie" for each area represented. Again, the power in this approach is "seen" clearly by comparing in
rather straight count and percentage. This analytical tool is a simple "slice out of the pie" for each area improvements. This
is particularly true as related to attribute data at the workplace for quick and easy analytical aids for operators.

5.3.1 General Directions


Identify defects in a fixed number of final products of the process. Categorize the defects and quantify the number of
products associated with each defect. Place the defects in the first column of the table and the number of products with the
corresponding defects in the second column. The Third Column will automatically calculate the % frequency of each defect by
dividing each defect frequency by the total number of defects in the study. These values will be automatically appear in the
pie chart, with each slice of the pie representing a problem area. Using this graphical tool, a comparison between the various
defects can be made. The defect occupying the largest area in the pie-chart is the most problematic and requires immediate
attention.

5.3.2 Attribute Table


Greensboro Plant
Number of
Attributes/Defect
Products with the
s
Defect
Gapping
26334
Mold Flash
9964
Rough
Surfaces/Orange
8541
Peel
Warpage
6406
Excessive Shrinkage
2847
Mould Sticking
2847
Brittleness
2135
Low Gloss
2135
Un-melted Granules
1779
Weak Weldiness
1423

% 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%

Pie Chart Show ing Defe cts & % Frequency

Excessive Shrinkage Mould Sticking


5%
5%
Gapping
Warpage
46%
11%
Rough Surfaces/Orange Peel
Mold Flash
15%
18%

Clinton Plant
Number of
Attributes/Defect
Products with the
s
Defect
Fractured
24617
Thermoforms

% Frequency
93%

Weak Weldiness
Discoloration

1324
529

5%
2%

Pie Chart Show ing Defe cts & % Frequency

Weak Weldiness Discoloration


2%
5%

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%

Pie Chart Show ing Defe cts & % Frequency

Discoloration Materials
Improper handling
1%
4%
6%
Stress cracking Out of tolerance
45%

Pie Chart Show ing Defe cts & % Frequency

Discoloration Materials
Improper handling
1%
4%
6%
Out
of
tolerance
Stress cracking
45%
9%
Burrs
16% Poor finish
20%

Return to 5.0

ONGOING PROCESS CONTROL PLAN


5.4 OPCP (ONGOING PROCESS CONTROL PLAN)
Gilcaro

Customer:

Prototype

Page 1 of 1

Pre- Launch

Control Plan Number:

Production

Key Contact/Phone:

Date(Original):

Mike Carper

2006-12345

Part Number/Latest Change Level:

6-Jan-05

Core Team:

12-Apr-06

Customer Engineering Approval/Date:

682

BGSU 5678
Part Name/Description:

5/20/2006

Supplier/Plant Approval/Date:

6/1/2006

Customer Quality Approval/Date:

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

FIFO / Storage & Preservation


Procedure

Sample

Control
Method

Reaction Plan

Per Lot #

Certified vendors,
SOP certify receipts
Reconcile packing
slips with PO and

Notify supplier. Isolate


material until disposition
is reached. Corrective
action.

Per Lot

Fork lift operator


verifies goods against

invoices
2

Store Raw Material

Warehouse

Notify supervisor. Initiate


corrective action.

storage floor plan.


3

Move Raw Material

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

1st, last &


hourly

Establish procedures
& work Instructions
Provide forklift training
for materials handlers
SOP to review mat'l

Notify Material Handling


Supervisor. Initiate
a corrective action.

prior to use
Barcode router &
scan at machine to

Stop production. Inform


Supervisor. Sort back

load correct program

through till pts. conform.

SOP requiring review


Inspection

6&7

Packaging &

Bruno Press

Width

Amount per container

Labeling

539.9 mm

+/- 5.0mm

Must have correct

"

"

Visual / Counting

All

"

amount of parts
2

Label information

Relocation to

Bar coded label must reflect


the proper part #, serial #

of prod ID at each step


"

Per

Certified packaging tech.

Re-Count &

Order

Random packaging checks

Re-Pack Parts.

"

"

"

Trending of errors
"

Visual

All

Per Lot

Training

Notify Material Handling

Certified material handlers

Supervisor. Initiate

and quantity
8

Move Finished Goods

Warehouse

FIFO

Store Finished Goods

Warehouse / Shipping Area

Storage

Storage & Preservation

Change label to
reflect the proper
information.

Warehouse

"

Visual

All

Per Lot

SOP requiring Oper. review of


package at dock audit

a corrective action.

Training & shelf guards

Notify supervisor. Initiate

Bar coded containers are


scanned to location

corrective action.

SOP requiring Oper. review of


package at dock audit
Procedure

Certified material handlers


Monthly inventory of storage
location by scans

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

As per Work Instruction

Check Sheets, JCPs,


Blue Prints.

As per Dock Audit


procedure.

Parts in carton must match

Visual, Work order

"

Work order / Label

Label

On-time and free of


damage

Mapics tracking
system.

100%

All
Orders

Dock Audit
check sheet.
Auditor breaks
"

Isolate order.
Hold for 100%
inspection.
"

Production router system


tracks progress
Carrier audits
Known late deliveries
expedited
Deliveries are tracked
- Loading instructions,
Dock audit of paperwork
Router software

Corrective action.
Notify customer.

changes to notify Prod. Ctrl.


of potential late deliveries

Return to 5.0

Potential
Failure Mode and Effects Analysis
(PROCESS FMEA)

5.5 FMEA - INJECTION MOLDING


Item:

Plastic Injection Molding Operation

Model Year(s) Vehicles:


Core Team:
PROCESS
DESCRIPTION

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:

Greensboro Mfg. Mgmt.

Prepared by:

S. Stamm

Key Date:

June 2, 2007

FMEA Date (Orig):

POTENTIAL CAUSES OF FAILURE O


C
C

CURRENT CONTROLS
Prevention

CURRENT CONTROLS
Detection

D
E
T

R
P
N

RECOMMENDED
ACTION

- Will not meet our or cust.


specifications. (e.g. color)

Vendor problem/comm.

Receiving Insp.

35 None

- Will not meet our or cust.


specifications. (e.g. mech. specs.)

Vendor problem/comm.

Receiving Insp.

32 None

- Raw Mat'l not to


specification.

- Will not meet our or


cust. specifications.

Vendor or communication
problem

Spec. Review w/ Vendor Receiving Insp.

21 None

-No Mat'l
certification.

-Mat'l of unknown quality

Vendor problem

Receiving Insp.

-Receiving Insp.

-Possible production

Receiving resources

behind schedule.
Damaged Mat'l

shutdown
Damaged mat'l used in mfg.

1 Outsource Receiving Insp Overtime


when busy

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

Damaged mat'l used in mfg.

Lack of Training/Awareness

Bar coded Inventory


positions
Training

4 INJECTION

Flash

Excessive trimming rework

Mold misalignment

Part will not release


from mold

Damaged part/Mold clean up

Damaged part/Mold clean up

1 RECEIVING

2 STORE
Raw Material

- Receive wrong
material.

ACTION TAKEN

6/5/2007 SOP complete


and approved

12

12

Visual Inspection

20 None

Improper mold cleaning

SOP for mold cleaning


Visual Inspection

12 None

Ejection pin jammed

1 PM for mold

Visual Inspection

Damaged part/Mold clean up

Release chemical not used

SOP for mold release


Visual Insp.

12 None

Part not to specification

Nozzle blockage

14 None

Mat'l feed mechanism jammed

28 None

Feed screw or barrel blockage

1 SOP to clean nozzle ever Visual Insp.


10 hours of use.
2 SOP to clean feed mech. Visual Insp.
every 10 hours of use
1 SOP to purge barrel everyVisual Insp.
10 hours of use.

14 None

None

4. Greensboro Injection Molding


attributes
Incomplete seal of mold.

1 Air pressure check.

15 SOP for material load.6/12/07

SOP proposed.

Mold Flash

Excess material used.

Too much material.

1 Check injection pressure. Visual inspection.

10 SOP for material load.6/12/07

SOP proposed.

Rough Surfaces /
Orange Peel

Visually unappealing.

Excess moisture.

2 Check humidity.

24 SOP for humidity con 6/12/2007 SOP proposed.

Warpage

Warped part.

Anisotropic Shrinkage

1 Increase process temperaFlatness measurement.

18 SOP for temperature 6/12/2007 SOP proposed.

Excessive Shrinkage

Incomplete part.

Insufficient mataerial.

1 Increase process pressureWeight measurement.

None

6/12/2007

Mould Sticking

Uneven, lined surface.

Mold misalignment.

1 Preventive Maintenance. Visual inspection.

18 None

6/12/2007

Page 22 of 42

Injection volume monitoring 3

Visual inspection.

R
P
N

108 SOP requiring Oper.


6/5/2007 SOP complete
review of mat'l prior to use
and approved
10 None

2 Molds held to close


tolerance
3

D
E
T

1 14

108 SOP requiring Oper.


6/5/2007 SOP complete
review of mat'l prior to use
and approved

Void or bubbles in product.

O
C
C

Gapping

S
E
V

Certified mat'l handlers

MOLDING

Short Shots

Certified mat'l handlers

6/2/2007 (Rev.) 01
RESP. COMP.
DATE

Potential
Failure Mode and Effects Analysis
(PROCESS FMEA)

5.5 FMEA - INJECTION MOLDING


Item:

Plastic Injection Molding Operation

Model Year(s) Vehicles:


Core Team:
PROCESS
DESCRIPTION

N/A

S. Stamm, M. Carper
POTENTIAL FAILURE
MODE

EFFECTS OF FAILURE

S
E
V

IJ-001

Greensboro Mfg. Mgmt.

Prepared by:

S. Stamm

Key Date:

June 2, 2007

FMEA Date (Orig):

POTENTIAL CAUSES OF FAILURE O


C
C

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.

1 Increase process temperaVisual inspection.

None

6/12/2007

Weak Weldiness

Incomplete part.

Insufficient mataerial.

1 Increase process pressureFlatness measurement.

None

6/12/2007

Wrinkles

Uneven, lined surface.

Mold misalignment.

1 Preventive Maintenance. Visual inspection.

18 None

6/12/2007

Brown Stains

Visually unappealing.

Excess moisture w/ benzene.

2 Check humidity.

Visual inspection.

24 None

6/12/2007

Burn Marks

Visually unappealing.

Excess air.

2 Check injection pressure. Visual inspection.

24 None

6/12/2007

Discoloration

Visually unappealing.

Fluid contamination.

2 Check injection pressure. Visual inspection.

24 None

6/12/2007

Drooling

Visually unappealing.

Excess air.

2 Check injection pressure. Visual inspection.

24 None

6/12/2007

Short Shot

Incomplete part.

Insufficient mataerial.

1 Increase process pressureWeight measurement.

None

6/12/2007

Sinks / Voids

Incomplete part.

Insufficient mataerial.

1 Increase process pressureWeight measurement.

None

6/12/2007

Streaks / Splash Marks

Visually unappealing.

Excess residence time.

2 Check control timer.

Visual inspection.

24 None

6/12/2007

Flow Marks / Jetting

Visually unappealing.

Irregular melting.

2 Check control heater.

Visual inspection.

24 None

6/12/2007

Odor

Part failure.

Excess temperature.

1 Check control heater.

Smell check.

18 None

6/12/2007

Screw Slippage

Incomplete part.

Insufficient mataerial.

1 Increase process pressureWeight measurement.

6/12/2007

Non conforming part


missed at insp.

Customer gets non-conforming


part

Insp. Fatigue/Boredom

3 Insp. Breaks

6/5/2007 SOP complete


84 SOP for product
and approved.
review at packaging step

Insp. Plan vs. 100% Insp.

1 Insp. Plan Statistically


Selected

28 None

Calibration date expired

1 Gage calibration programInsp SOP requires checking

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

Customer gets non-conforming


part

Incorrect no. of parts


in container

Container protection of parts


compromised

Packaging technician error

Random packaging checks


Trending of errors

24 None

Increased shipping and production


costs

Packaging technician error

Random packaging checks


Trending of errors

24 None

Customer aggravation

Packaging technician error

Random packaging checks


Trending of errors

20 None

of gage calibration status

Page 23 of 42

2 28

Potential
Failure Mode and Effects Analysis
(PROCESS FMEA)

5.5 FMEA - INJECTION MOLDING


Item:

Plastic Injection Molding Operation

Model Year(s) Vehicles:


Core Team:
PROCESS
DESCRIPTION

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

Greensboro Mfg. Mgmt.

Prepared by:

S. Stamm

Key Date:

June 2, 2007

FMEA Date (Orig):

POTENTIAL CAUSES OF FAILURE O


C
C

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

Packaging technician error

1 Labeling software validat Certified packaging tech.

12 None

Loss of traceability
Damaged mat'l gets to customer

6
7

packaging technician error


Lack of training/awareness

1 Labeling software validat Certified packaging tech.

Damaged Mat'l

Training

Certified material handlers

3
6

Damaged Mat'l

Damaged mat'l gets to customer

Training & shelf guards

Certified material handlers

Customer orders not filled

Damaged by mat'l moving


equipment or technicians
Mat'l not stored or moved
without scanning

Lost mat'l

Bar coded containers are


scanned to location

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 order not

Customer aggravation

Dock auditor fatigue or

Auditor breaks

Dock audit checklist

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

Late delivery from Chilco

Production router system


tracks progress

Known late deliveries


expedited

36 None

Carrier problems

Carrier audits

Deliveries are tracked

12 None

Customer chargebacks to Chilco

Late delivery from Chilco

Production router system


tracks progress

- Loading instructions,

90 Router software
12/31/2007
changes to notify Prod. Ctrl.
of potential late deliveries

Increased cust. inventory costs

Routing mishap

Dock audit of paperwork

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:

Plastic Injection Molding Operation

FMEA Number:

IJ-001

Process Responsibility:

Greensboro Mfg. Mgmt.

Prepared by:

S. Stamm

Key Date:

June 2, 2007

FMEA Date (Orig):

Harpster, R. (2005). Demystifying Design FMEAs. Quality, 44(4), 20.

Model Year(s) Vehicles:

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

FMEA from Theory to

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

5.5 FMEA - MACHINING


Item:

Machining Operation

Process &/or subprocess:


Core Team:
PROCESS
DESCRIPTION

1 RECEIVING

2 STORE
Raw Material

N/A

S. Stamm, M. Carper; M. Chandler


POTENTIAL FAILURE
MODE

EFFECTS OF FAILURE

S
E
V

- Will not meet our or cust.


specifications.
(e.g. dimensional specs.)

- Will not meet our or cust.


specifications. (e.g. mech. specs.)

- Raw Mat'l not to


specification.

- Will not meet our or


cust. specifications.

-No Mat'l
certification.

-Mat'l of unknown quality

-Receiving Insp.
behind schedule.

-Possible production
shutdown

Damaged Mat'l

Damaged mat'l used in mfg.

Lost Mat'l

Production Interruption

Damaged mat'l used in mfg.

Part not machined to


injection overpresurized
dieseling in the mold
uneven shine
uneven shine
Uneven oxidation
lumpy surface

Will not meet customers needs


visually unappealing
part(s) failure
visually unappealing
visually unappealing
visually unappealing
Will not meet customers needs

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

Will not meet customers

C
L
A
S
S

specifications. Customer
rejection.
Will not meet customers
specifications. Customer
rejection.

Will not meet customers


specifications. Customer
rejection.

Will not meet customers


specifications. Customer
rejection

Gage out of
calibration

Customer gets non-conforming


part

Wrong part is
produced / wrong
amount of parts.

Customer rejection.
Customer may not have
enough to fill orders.

Ineffective container protection of parts

Surface finish not


to specification

6 PACKAGING Clinton attributes


Fractured Thermoforms Incorrect no. of parts
Packaging mold
defects

Broken transport contain Damage to mold.


Product not packaged successfully.

Packaging die cut error asymmetrical package

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

Damaged mat'l gets to customer

Lost mat'l

Customer orders not filled

10 DOCK AUDIT

Customer order not

Customer aggravation

Custom aggravation and potential


downtime

correctly filled
11 SHIPPING

Late delivery

Early delivery

Customer chargebacks to Chilco

Increased cust. inventory costs

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.

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

Not enough receiving


resources

1 Outsource Receiving Insp.


when busy

Overtime

10

Lack of Training/Awareness

Training

Certified mat'l handlers

108

Training/Storage Capacity

Inventory expediter

10

Lack of Training/Awareness

Training

Certified mat'l handlers


certification

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

Wrong program selected

Spec. Review w/ Vendor

Inspection at Operation

Set-Up Sheet

Inspection at Operation

Material variation

1 Specification review with


vendor

Dull tooling

2 Machining prgm. has


tool hr limitations

Bad tooling

1 Tooling spec. review with


vendor

Calibration date expired

Material certification review


at receiving inspection

14

32

Receiving inspection review


tooling certifications

14

1 Gage calibration program

Insp SOP requires checking


of gage calibration status

14

Not following Work Inst.


Work order discrepancy.

1 Production order/router
system in place

Product traceability at all


production steps

56

Packaging technician error

1 Training.

Random packaging checks

14

Vendor error.
Vendor error.

1 Tooling spec. review with ve Random packaging checks


1 Tooling spec. review with ve Random packaging checks

1
2

8
12

Trending of errors
Packaging technician error

Random packaging checks


Trending of errors

24

Packaging technician error

Random packaging checks


Trending of errors

20

Packaging technician error

1 Labeling software validated Certified packaging tech.

12

packaging technician error


Lack of training/awareness

1 Labeling software validated Certified packaging tech.

Training

Certified material handlers

18
126

Damaged by mat'l moving


equipment or technicians
Mat'l not stored or moved
without scanning

Training & shelf guards

Certified material handlers

126

Bar coded containers are


scanned to location

Monthly inventory of
storage location by scans

18

Dock auditor fatigue or

Auditor breaks

Dock audit checklist

12

Late delivery from Chilco

Production router system


tracks progress

Known late deliveries


expedited

36

Carrier problems

Carrier audits

Deliveries are tracked

12

Late delivery from Chilco

Production router system


tracks progress

- Loading instructions,

90

Routing mishap

Dock audit of paperwork

needing re-training

FMEA Number:

M-001

Prepared by:

M. Chandler

FMEA Date (Orig):


RECOMMENDED
ACTION

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

SOP requiring Oper.


6/5/2007 SOP written and
review of mat'l prior to use
approved
None

12

SOP requiring Oper.


6/5/2007 SOP written and
review of mat'l prior to use
approved

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

Bar code router and

6/5/2007 SOP written and


approved

###
###
###
###
###
###
###

12/31/2007

scan at machine to
load correct program
None

None

None

None

6/5/2007 SOP written and


SOP requiring Oper.
complete
review and doc. of product
identifiers and quantity

2 14

14

14

at each production step

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

SOP written and


complete
SOP written and
complete

None
None

None
Router software
12/31/2007
changes to notify Prod. Ctrl.
of potential late deliveries
None

Return Home

Return Home

5.8 VARIABLE DATA GAGE REPRODUCIBILITY & REPEATABILITY SYSTEM (VDGRARS)


Part Description:

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:

Injection Molding, operation


#0110

Tolerance: 0.02

This characteristic measures the "lip" dimension of part #81550/60-00040-00.


This dimension is important as the "lip" must fit flush into part #81550/6000050-01.

Range and X-Bar

Return to 5.0

Mitutoyo Digital Caliper #


25-2007-001-A

38

Gage R&R Data Table:


Operator A

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

0.64 0.642 0.001

0.641

0.64 0.642 0.002

0.64

0.64

Trial 2

Trial 3

Trial 1

0.670 0.670 0.670


Operator A

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

0.668 0.668 0.668

Trial 2

0.64 0.000
Trial 3

0.667 0.667 0.667

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

Calculate %EV where:


%EV= 100[(EV)/(Tolerance)]
%EV= 23.64

Calculate Appraiser Variation (AV) where:


AV = [ (Diff Max-Min)(K2)] - [(EV) / (n x r)]

Calculate %AV where:


% AV = 100 [ (AV) / (Tolerance)]

AV =

0.007

Calculate R & R Where:


R&R = (EV) + (AV)
R&R= 0.009

% AV= 59.80
Calculate % R & R Where:
% R&R= ( % EV) + (% AV)
% R&R=

64.3

40

5.10 Cpk Calculation

5.10 Cpk Calculation


Directions :
1. Input the data in the Data column (below), it will accommodate up to 30 points, delete data that is not yours.
2. Input the Upper Spec & Lower Spec in the cells below the graph. You will find the Cpk at the bottom of the page, in the double lined box.
Data (in mg.)

33.58

33.49

34.18

35.28

34.52

34.35

33.92

Run Chart

Weight (in mg)

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

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