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

Record most frequently occurring issues

Reduce Identify which problems to use other Six Sigma
Pareto Analysis contributing to increased variation at each of the
Variation tools on first to achieve desired quality outcome.
sites.

VOC:
understand Assess each element of a safety checklist to
Identify line items where critical to safety
Safety Checklist requirements determine whether corrective or preventive
requirements may not be met.
that are critical action is needed.
to safety

Record most frequently occurring issues

Reduce Identify which problems to use other Six Sigma
Pie Chart contributing to increased variation at each of the
Variation tools on first to achieve desired quality outcome.
sites.

Understand how variation is controlled at each

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

Reduce Record all possible locations at which deviations Understand where the most failure prone parts of
FMEA
Variation from specifications within the process can occur. the process are.

Injection Molding Provides FMEA on injection molding operations.

Machining Provides FMEA on machining operations.

Understand whether there is an issue with one

Reduce
VDGRARS Conduct Gage R&R on lip. part in the process, highlighted by previous
Variation
analysis as a potential source of more variability.
 Reduce Evaluate process capability for one part in Chilco
Cpk Calculation Determine whether process needs to be adjusted.
Variation production process.
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. 129-
154.

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 Identified, Frequency, % Occurrence. Greensboro - Injection Molding

# of Total % of Total
Attributes Occurences Occurrence
% of Total Occurence

Gapping 26334 37%

Mold Flash 9964 14% 1.4.4 Pareto Chart - Greensboro Quality Issues
40%
Rough Surfaces / Orange Peel 8541 12% 37%

Warpage 6406 9% 35%

Excessive Shrinkage 2847 4% 30%

25%

20%
 % of Total Occuren
1.4.4 Pareto Chart - Greensboro Quality Issues
40%
37%

35%

30%
Mould Sticking 2847 4%
25%
Brittleness 2135 3%
Low Gloss 2135 3% 20%

Un-melted Granules 1779 2.50% 15% 14%

12%
Weak Weldiness 1423 2% 9%
10%
Wrinkles 1068 1.50%
5% 4% 4%
Brown Stains 712 1% 3% 3% 3% 2% 2% 1% 1% 1% 1% 1% 1%
1% 1% 1% 1%
Burn Marks 712 1% 0%
Discoloration 712 1%

Streaks / Splash Marks

Rough Surfaces / Orange Peel

Un-melted Granules

Weak Weldiness

Brown Stains

Burn Marks

Sinks / Voids
Brittleness

Low Gloss

Wrinkles
Excessive Shrinkage

Short Shot

Screw Slippage
Warpage

Flow Marks / Jetting

Mould Sticking

Drooling

Odor
Mold Flash

Discoloration
Gapping
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% Attributes
Screw Slippage 356 0.50%

Return to 5.0

Attributes Identified, Frequency, % Occurrence. Clinton - Packaging

# of Total % of Total
Attributes Occurences Occurrence
Fractured Thermoforms 24617 93%
Weak Weldiness 1324 5%
1.4.4 Pareto Chart - Clinton Quality Issues
% of Total Occurence

100%
Discoloration 529 2% 93%
90%

80%

70%

60%

50%
 1.4.4 Pareto Chart - Clinton Quality Issues

% of Total Occurence
100%
93%
90%

80%

70%

60%

50%

40%

30%

20%

10% 5%
2%
0%

Fractured Thermoforms

Weak Weldiness

Discoloration
Attributes

Attributes Identified, Frequency, % Occurrence. Manchurian - Machining

# of Total % of Total
Attributes Occurences Occurrence
Out of tolerance 132115 43%
Poor finish 60313 21% 1.4.4 Pareto chart - Manchurian Quality Issues
Burrs 45953 16% 50%

Stress cracking 25849 9% 45% 43%

40%

35%

30%
ce
 1.4.4 Pareto chart - Manchurian Quality Issues
50%

45% 43%

Improper handling 17232 6% 40%

Discoloration 11488 4% 35%
Materials 2872 1% 30%

% of Total Occurence
25%
21%
20%
16%
15%
9%
10%
6%
4%
5%
1%
0%

Burrs

Materials
Out of tolerance

Discoloration
Poor finish

Stress cracking

Improper handling
Attributes
 1%
Flow Marks / Jetting

1%
Odor

1%
Screw Slippage
Materials

1%
5.2 SAFETY INSPECTION CHECKLIST
Not Not
Checklist Item OK Safe App. Actual Site Explanations/ Action/Other
General Safety
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
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 Products
Attributes/Defects % Frequency
with the Defect
Gapping 26334 37%
Mold Flash 9964 14%
Rough
8541 12%
Surfaces/Orange Peel
Warpage 6406 9%
Excessive Shrinkage 2847 4%
Mould Sticking 2847 4%
Brittleness 2135 3%
Low Gloss 2135 3%
Un-melted Granules 1779 3%
Weak Weldiness 1423 2%
Wrinkles 1068 2%
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 1%
Screw Slippage 356 1%

Pie Chart Showing Defects & % Frequency

Excessive Shrinkage Mould Sticking

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

Clinton Plant
Number of Products
Attributes/Defects % Frequency
with the Defect
Fractured
24617 93%
Thermoforms
Weak Weldiness 1324 5%
Discoloration 529 2%

Pie Chart Showing Defects & % Frequency

Weak Weldiness Discoloration

5% 2%

Fractured Thermoforms
93%

Beijing Plant
Number of Products
Attributes/Defects % Frequency
with the Defect
Out of tolerance 132115 45%
Poor finish 60313 20%
Burrs 45953 16%
Stress cracking 25849 9%
Improper handling 17232 6%
Discoloration 11488 4%
Materials 2872 1%

Pie Chart Showing Defects & % Frequency

Improper handling Discoloration Materials

6% 4% 1%

Stress cracking Out of tolerance

45%
 Pie Chart Showing Defects & % Frequency

Improper handling Discoloration Materials

6% 4% 1%

Stress cracking Out of tolerance

9% 45%

Burrs
16% Poor finish
20%

Return to 5.0
 ONGOING PROCESS CONTROL PLAN

5.4 OPCP (ONGOING PROCESS CONTROL PLAN)

Customer: Gilcaro Page 1 of 1

Prototype Pre- Launch ✘ Production Key Contact/Phone: Date(Original): Date(Revision):

Control Plan Number: 2006-12345 Mike Carper 6-Jan-05 12-Apr-06

Part Number/Latest Change Level: Core Team: Customer Engineering Approval/Date:
BGSU 5678 682 5/20/2006
Part Name/Description: Supplier/Plant Approval/Date: 6/1/2006 Customer Quality Approval/Date:
ABC Housing 6/1/2006
Supplier/Plant: Supplier Code: Other Approval/Date: Other Approval/Date:
GBO GBO 789
Part Process Name/ Machine, Device, Characteristics Special Methods
Process Operation description Jig, Tools. Char. Product/Process Evaluation Measurement Sample Control Reaction Plan
Number For Mfg. No Product Process Class Specification/Tolerances Technique Size Frequency Method
1 Receiving Receiving Dock 1 Receipt & * Quantity, delivery Visual All Per Lot # Certified vendors, Notify supplier. Isolate
SOP certify receipts material until disposition
Verification & damage. Reconcile packing is reached. Corrective
slips with PO and action.
invoices
2 Store Raw Material Warehouse 1 Storage FIFO / Storage & Preservation Visual All Per Lot Fork lift operator Notify supervisor. Initiate
Procedure verifies goods against corrective action.
storage floor plan.
3 Move Raw Material Bruno Press 1 Relocation to FIFO Visual All Per Lot Establish procedures Notify Material Handling
Machine & work Instructions Supervisor. Initiate
Provide forklift training a corrective action.
for materials handlers
SOP to review mat'l
prior to use
4&5 Machining & Bruno Press 1 Length 759.4 mm +/- 5.0mm Tape measure 1 piece 1st, last & Barcode router & Stop production. Inform
Injection per cavity hourly scan at machine to Supervisor. Sort back
load correct program through till pts. conform.
SOP requiring review
Inspection of prod ID at each step
2 Width 539.9 mm +/- 5.0mm " " " " "

6&7 Packaging & Bruno Press 1 Amount per container Must have correct Visual / Counting All Per Certified packaging tech. Re-Count &
Labeling amount of parts Order Random packaging checks Re-Pack Parts.
Trending of errors
2 Label information Bar coded label must reflect " " " " Change label to
the proper part #, serial # reflect the proper
and quantity information.
8 Move Finished Goods Warehouse 1 Relocation to FIFO Visual All Per Lot Training Notify Material Handling

Warehouse Certified material handlers Supervisor. Initiate

SOP requiring Oper. review of

package at dock audit a corrective action.
9 Store Finished Goods Warehouse / Shipping Area 1 Storage Storage & Preservation Visual All Per Lot 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 1 Overall condition of As per Work Instruction Check Sheets, JCPs, As per Dock Audit Dock Audit Isolate order.
parts, labels, cartons, Blue Prints. procedure. check sheet. Hold for 100%
amounts etc. Auditor breaks inspection.
2 Part Verification Parts in carton must match Visual, Work order " " "
Work order / Label Label

11 Ship to Customer Shipping Dock 1 Part delivered to On-time and free of Mapics tracking 100% All Production router system Corrective action.
the customer damage system. Orders tracks progress Notify customer.
Carrier audits
Known late deliveries
expedited
Deliveries are tracked
- Loading instructions,
Dock audit of paperwork
Router software

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 FMEA Number: IJ-001

Model Year(s) Vehicles: N/A Process Responsibility: Greensboro Mfg. Mgmt. Prepared by: S. Stamm

Core Team: S. Stamm, M. Carper Key Date: June 2, 2007 FMEA Date (Orig): 6/2/2007 (Rev.) 01
PROCESS POTENTIAL FAILURE EFFECTS OF FAILURE S C POTENTIAL CAUSES OF O CURRENT CONTROLS CURRENT CONTROLS D R RECOMMENDED RESP. COMP. ACTION TAKEN S O D R
DESCRIPTION MODE E L FAILURE C Prevention Detection E P ACTION DATE E C E P
V A C T N V C T N
S
S

1 RECEIVING - Receive wrong - Will not meet our or cust. 7 Vendor problem/comm. 1 Receiving Insp. 5 35 None
material. specifications. (e.g. color)

- Will not meet our or cust. 8 Vendor problem/comm. 2 Receiving Insp. 2 32 None
specifications. (e.g. mech. specs.)

- Raw Mat'l not to - Will not meet our or 7 Vendor or communication 1 Spec. Review w/ Vendor Receiving Insp. 3 21 None
specification. cust. specifications. problem

-No Mat'l -Mat'l of unknown quality 7 Vendor problem 3 Receiving Insp. 3 63 SOP requiring no 6/5/2007 SOP complete 7 2 1 14
certification. receipt of mat'l without and approved
certification.
-Receiving Insp. -Possible production 5 Receiving resources 1 Outsource Receiving Insp. Overtime 2 10 None
behind schedule. shutdown when busy
2 STORE Damaged Mat'l Damaged mat'l used in mfg. 6 Lack of Training/Awareness 3 Training Certified mat'l handlers 6 108 SOP requiring Oper. 6/5/2007 SOP complete 6 2 1 12
Raw Material review of mat'l prior to use and approved
Lost Mat'l Production Interruption 5 Training/Storage Capacity 1 Bar coded Inventory 2 10 None
positions
3 MOVE Damaged Mat'l Damaged mat'l used in mfg. 6 Lack of Training/Awareness 3 Training Certified mat'l handlers 6 108 SOP requiring Oper. 6/5/2007 SOP complete 6 2 1 12
Raw Material review of mat'l prior to use and approved
4 INJECTION Flash Excessive trimming rework 5 Mold misalignment 2 Molds held to close Visual Inspection 2 20 None
MOLDING tolerance
Part will not release Damaged part/Mold clean up 4 Improper mold cleaning 3 SOP for mold cleaning 1 12 None
from mold Visual Inspection
Damaged part/Mold clean up 4 Ejection pin jammed 1 PM for mold Visual Inspection 1 4 None

Damaged part/Mold clean up 4 Release chemical not used 3 SOP for mold release 1 12 None
Visual Insp.
Short Shots Part not to specification 7 Nozzle blockage 1 SOP to clean nozzle every Visual Insp. 2 14 None
10 hours of use.
7 Mat'l feed mechanism jammed 2 SOP to clean feed mech. Visual Insp. 2 28 None
every 10 hours of use
7 Feed screw or barrel blockage 1 SOP to purge barrel every Visual Insp. 2 14 None
10 hours of use.
4. Greensboro -
Injection Molding
attributes

Gapping Void or bubbles in product. 5 Incomplete seal of mold. 1 Air pressure check. Injection volume monitoring. 3 15 SOP for material load.6/12/07 SOP proposed.

Mold Flash Excess material used. 5 Too much material. 1 Check injection pressure. Visual inspection. 2 10 SOP for material load.6/12/07 SOP proposed.

Rough Surfaces / Orange

Peel Visually unappealing. 6 Excess moisture. 2 Check humidity. Visual inspection. 2 24 SOP for humidity contr 6/12/2007 SOP proposed.

Warpage Warped part. 9 Anisotropic Shrinkage 1 Increase process temperatureFlatness measurement. 2 18 SOP for temperature m 6/12/2007 SOP proposed.

Excessive Shrinkage Incomplete part. 9 Insufficient mataerial. 1 Increase process pressure. Weight measurement. 1 9 None 6/12/2007

Mould Sticking Uneven, lined surface. 9 Mold misalignment. 1 Preventive Maintenance. Visual inspection. 2 18 None 6/12/2007

Page 20 of 39
 Potential
Failure Mode and Effects Analysis
(PROCESS FMEA)
5.5 FMEA - INJECTION MOLDING
Item: Plastic Injection Molding Operation FMEA Number: IJ-001

Model Year(s) Vehicles: N/A Process Responsibility: Greensboro Mfg. Mgmt. Prepared by: S. Stamm

Core Team: S. Stamm, M. Carper Key Date: June 2, 2007 FMEA Date (Orig): 6/2/2007 (Rev.) 01
PROCESS POTENTIAL FAILURE EFFECTS OF FAILURE S C POTENTIAL CAUSES OF O CURRENT CONTROLS CURRENT CONTROLS D R RECOMMENDED RESP. COMP. ACTION TAKEN S O D R
DESCRIPTION MODE E L FAILURE C Prevention Detection E P ACTION DATE E C E P
V A C T N V C T N
S
S

Brittleness Unacceptable product. 10 Vendor error. 1 Vendor support. Hardness testing. 1 10 None 6/12/2007

Low Gloss Visually unappealing. 6 Excess moisture. 2 Check humidity. Visual inspection. 2 24 None 6/12/2007

Un-melted Granules Incomplete part. 9 Insufficient temperature. 1 Increase process temperatureVisual inspection. 1 9 None 6/12/2007

Weak Weldiness Incomplete part. 9 Insufficient mataerial. 1 Increase process pressure. Flatness measurement. 1 9 None 6/12/2007

Wrinkles Uneven, lined surface. 9 Mold misalignment. 1 Preventive Maintenance. Visual inspection. 2 18 None 6/12/2007

Brown Stains Visually unappealing. 6 Excess moisture w/ benzene. 2 Check humidity. Visual inspection. 2 24 None 6/12/2007

Burn Marks Visually unappealing. 6 Excess air. 2 Check injection pressure. Visual inspection. 2 24 None 6/12/2007

Discoloration Visually unappealing. 6 Fluid contamination. 2 Check injection pressure. Visual inspection. 2 24 None 6/12/2007

Drooling Visually unappealing. 6 Excess air. 2 Check injection pressure. Visual inspection. 2 24 None 6/12/2007

Short Shot Incomplete part. 9 Insufficient mataerial. 1 Increase process pressure. Weight measurement. 1 9 None 6/12/2007

Sinks / Voids Incomplete part. 9 Insufficient mataerial. 1 Increase process pressure. Weight measurement. 1 9 None 6/12/2007

Streaks / Splash Marks Visually unappealing. 6 Excess residence time. 2 Check control timer. Visual inspection. 2 24 None 6/12/2007

Flow Marks / Jetting Visually unappealing. 6 Irregular melting. 2 Check control heater. Visual inspection. 2 24 None 6/12/2007

Odor Part failure. 9 Excess temperature. 1 Check control heater. Smell check. 2 18 None 6/12/2007

Screw Slippage Incomplete part. 9 Insufficient mataerial. 1 Increase process pressure. Weight measurement. 1 9 None 6/12/2007

5 INSPECTION
Non conforming part Customer gets non-conforming 7 Insp. Fatigue/Boredom 3 Insp. Breaks 4 84 SOP for product 6/5/2007 SOP complete 7 2 2 28
missed at insp. part review at packaging step and approved.
7 Insp. Plan vs. 100% Insp. 1 Insp. Plan Statistically 4 28 None
Selected

Gage out of Customer gets non-conforming 7 Calibration date expired 1 Gage calibration program Insp SOP requires checking 2 14 None
calibration part of gage calibration status

6 PACKAGING Incorrect no. of parts Container protection of parts 3 Packaging technician error 2 Random packaging checks 4 24 None
7 LABELING in container compromised Trending of errors

Increased shipping and production 3 Packaging technician error 2 Random packaging checks 4 24 None
costs Trending of errors

Customer aggravation 5 Packaging technician error 1 Random packaging checks 4 20 None

Trending of errors

Page 21 of 39
 Potential
Failure Mode and Effects Analysis
(PROCESS FMEA)
5.5 FMEA - INJECTION MOLDING
Item: Plastic Injection Molding Operation FMEA Number: IJ-001

Model Year(s) Vehicles: N/A Process Responsibility: Greensboro Mfg. Mgmt. Prepared by: S. Stamm

Core Team: S. Stamm, M. Carper Key Date: June 2, 2007 FMEA Date (Orig): 6/2/2007 (Rev.) 01
PROCESS POTENTIAL FAILURE EFFECTS OF FAILURE S C POTENTIAL CAUSES OF O CURRENT CONTROLS CURRENT CONTROLS D R RECOMMENDED RESP. COMP. ACTION TAKEN S O D R
DESCRIPTION MODE E L FAILURE C Prevention Detection E P ACTION DATE E C E P
V A C T N V C T N
S
S

Labeling error Customer aggravation 4 Packaging technician error 1 Labeling software validated Certified packaging tech. 3 12 None

Loss of traceability 6 packaging technician error 1 Labeling software validated Certified packaging tech. 3 18 None
8 MOVE Damaged Mat'l Damaged mat'l gets to customer 7 Lack of training/awareness 3 Training Certified material handlers 6 126 SOP requiring Oper. 6/5/2007 SOP complete 7 2 1 14
Finished Goods review of package at dock audit and approved
9 STORE Damaged Mat'l Damaged mat'l gets to customer 7 Damaged by mat'l moving 3 Training & shelf guards Certified material handlers 6 126 SOP requiring Oper. 6/5/2007 SOP complete 7 2 1 14
Finished Goods equipment or technicians review of package at dock audit and approved
Lost mat'l Customer orders not filled 6 Mat'l not stored or moved 1 Bar coded containers are Monthly inventory of 3 18 None
without scanning scanned to location storage location by scans
10 DOCK AUDIT Customer order not Customer aggravation 4 Dock auditor fatigue or 1 Auditor breaks Dock audit checklist 3 12 None
correctly filled needing re-training
11 SHIPPING Late delivery Custom aggravation and potential 6 Late delivery from Chilco 2 Production router system Known late deliveries 3 36 None
downtime tracks progress expedited

6 Carrier problems 1 Carrier audits Deliveries are tracked 2 12 None

Customer chargebacks to Chilco 5 Late delivery from Chilco 2 Production router system - Loading instructions, 9 90 Router software 12/31/2007 0
tracks progress changes to notify Prod. Ctrl.
of potential late deliveries
Early delivery Increased cust. inventory costs 4 Routing mishap 1 Dock audit of paperwork 1 4 None

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 FMEA’s 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 22 of 39
 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)
5.5Bouti,
FMEA A. &- Ait
INJECTION MOLDING
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
Harpster, R. (2005). Demystifying Design FMEAs. Quality, 44(4), 20.
Model Year(s) Vehicles: N/A Process Responsibility: Greensboro Mfg. Mgmt. Prepared by: S. Stamm
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
Core Team: S. Stamm, M. Carper
http://www.devicelink.com/mddi/archive/04/01/018.html Key Date: June 2, 2007 FMEA Date (Orig): 6/2/2007 (Rev.) 01
PROCESS POTENTIAL FAILURE EFFECTS OF FAILURE S C POTENTIAL CAUSES OF O CURRENT CONTROLS CURRENT CONTROLS D R RECOMMENDED RESP. COMP. ACTION TAKEN S O D R
Stamatis, D.H.
DESCRIPTION Failure Mode Effect Analysis:
MODE FMEA from Theory to Execution.
E Milwaukee,
L WI: FAILURE
ASQ Quality Press,C2003, pp. 129-154.
Prevention Detection E P ACTION DATE E C E P
V A C T N V C T N
S
S

Page 23 of 39
5.5 FMEA - MACHINING
Item: Machining Operation

Process &/or subprocess: N/A

Core Team: S. Stamm, M. Carper; M. Chandler

PROCESS POTENTIAL FAILURE EFFECTS OF FAILURE S C
DESCRIPTION MODE E L
V A
S
S

1 RECEIVING - Receive wrong - Will not meet our or cust. 8

material. specifications.
(e.g. dimensional specs.)

- Will not meet our or cust. 8

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

- Raw Mat'l not to - Will not meet our or 7

specification. cust. specifications.

-No Mat'l -Mat'l of unknown quality 7

certification.

-Receiving Insp. -Possible production 5

behind schedule. shutdown

2 STORE Damaged Mat'l Damaged mat'l used in mfg. 6

Raw Material
Lost Mat'l Production Interruption 5

3 MOVE Damaged Mat'l Damaged mat'l used in mfg. 6

Raw Material & finished

4 MACHINING -
Manchurian
attributes
Out of tolerance Part not machined to Will not meet customers needs 9
Poor finish injection overpresurized visually unappealing 8
Burrs dieseling in the mold part(s) failure 8
Stress cracking uneven shine visually unappealing 8
Improper handling uneven shine visually unappealing 8
Discoloration Uneven oxidation visually unappealing 8
Materials lumpy surface Will not meet customers needs 8

5 INSPECTION Dimension specifications. Customer

rejection.

Will not meet customers 9

 specifications. Customer
rejection.

Will not meet customers 7

specifications. Customer
rejection.

Surface finish not Will not meet customers 8

to specification specifications. Customer
rejection.

Will not meet customers 7

specifications. Customer
rejection

Gage out of Customer gets non-conforming 7

calibration part

Wrong part is Customer rejection. 7

produced / wrong Customer may not have
amount of parts. enough to fill orders.

6 PACKAGING -
Clinton attributes
Fractured Thermoforms Incorrect no. of parts Ineffective container protection of parts 7

Packaging mold defects Broken transport contain Damage to mold. 8

Packaging die cut errors asymmetrical package Product not packaged successfully. 6

7 LABELING in container compromised

Increased shipping and production 3

costs

Customer aggravation 5

Labeling error Customer aggravation 4

Loss of traceability 6
8 MOVE Damaged Mat'l Damaged mat'l gets to customer 7
Finished Goods
9 STORE Damaged Mat'l Damaged mat'l gets to customer 7
Finished Goods
Lost mat'l Customer orders not filled 6
10 DOCK AUDIT Customer order not Customer aggravation 4
correctly filled
11 SHIPPING Late delivery Custom aggravation and potential 6
downtime

Customer chargebacks to Chilco 5

Early delivery Increased cust. inventory costs 4

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 FMEA’s 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 O CURRENT CONTROLS CURRENT CONTROLS D R
FAILURE C Prevention Detection E P
C T N

Vendor problem/comm. 1 Receiving Insp. 2 16

Vendor problem/comm. 2 Receiving Insp. 2 32

Vendor or communication 1 Spec. Review w/ Vendor Receiving Insp. 3 21

problem

Vendor problem 3 Receiving Insp. 3 63

Not enough receiving 1 Outsource Receiving Insp. Overtime 2 10

resources when busy

Lack of Training/Awareness 3 Training Certified mat'l handlers 6 108

Training/Storage Capacity 1 Inventory expediter 2 10

Lack of Training/Awareness 3 Training Certified mat'l handlers 6 108

certification

Improper set-up / 1 training Set-Up Sheet 3 27

operator in hurry 2 training Final process steps 2 32
O-ring failure; PM issue 2 training Final process steps 2 32
Improper set-up / 2 training Final process steps 2 32
operator in hurry 1 training Final process steps 2 16
Improper set-up / 1 training Final process steps 2 16
operator in hurry 1 training Final process steps 3 24

fixturing Inspection at Operation

Wrong program selected 2 Set-Up Sheet 3 54

 Inspection at Operation

Material variation 1 Specification review with Material certification review 2 14

vendor at receiving inspection

Dull tooling 2 Machining prgm. has 2 32

tool hr limitations

Bad tooling 1 Tooling spec. review with Receiving inspection reviews 2 14

vendor tooling certifications

Calibration date expired 1 Gage calibration program Insp SOP requires checking 2 14
of gage calibration status

Not following Work Inst. 1 Production order/router Product traceability at all 8 56

Work order discrepancy. system in place production steps

Packaging technician error 1 Training. Random packaging checks 2 14

Vendor error. 1 Tooling spec. review with ve Random packaging checks 1 8

Vendor error. 1 Tooling spec. review with ve Random packaging checks 2 12

Trending of errors

Packaging technician error 2 Random packaging checks 4 24

Trending of errors

Packaging technician error 1 Random packaging checks 4 20

Trending of errors

Packaging technician error 1 Labeling software validated Certified packaging tech. 3 12

packaging technician error 1 Labeling software validated Certified packaging tech. 3 18

Lack of training/awareness 3 Training Certified material handlers 6 126

Damaged by mat'l moving 3 Training & shelf guards Certified material handlers 6 126
equipment or technicians
Mat'l not stored or moved 1 Bar coded containers are Monthly inventory of 3 18
without scanning scanned to location storage location by scans
Dock auditor fatigue or 1 Auditor breaks Dock audit checklist 3 12
needing re-training
Late delivery from Chilco 2 Production router system Known late deliveries 3 36
tracks progress expedited

Carrier problems 1 Carrier audits Deliveries are tracked 2 12

Late delivery from Chilco 2 Production router system - Loading instructions, 9 90

tracks progress

Routing mishap 1 Dock audit of paperwork 1 4

FMEA Number: M-001

Prepared by: M. Chandler

FMEA Date (Orig): 6/4/2007 (Rev.) 01

RECOMMENDED RESP. COMP. ACTION TAKEN S O D R
ACTION DATE E C E P
V C T N

None

None

None

SOP requiring no 6/5/2007 SOP written and 7 2 1 14

receipt of mat'l with- approved
out certification
None

SOP requiring Oper. 6/5/2007 SOP written and 6 2 1 12

review of mat'l prior to use approved
None

SOP requiring Oper. 6/5/2007 SOP written and 6 2 1 12

review of mat'l prior to use approved

Schedule PM 6/13/2007
Schedule PM 6/13/2007
Schedule PM 6/13/2007
Schedule PM 6/13/2007
Schedule PM 6/13/2007
Schedule PM 6/13/2007
Schedule PM 6/13/2007

Bar code router and 12/31/2007

scan at machine to
load correct program

None

None

None

None

SOP requiring Oper. 6/5/2007 SOP written and 7 1 2 14

review and doc. of product complete
identifiers and quantity
at each production step

None

Track as PM.
Track as PM.

None

None

None

None
SOP requiring Oper. 6/5/2007 SOP written and 7 2 1 14
review of package at dock audit complete
SOP requiring Oper. 6/5/2007 SOP written and 7 2 1 14
review of package at dock audit complete
None
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: Injection Molding, operation Tolerance: 0.02

#0110

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

Characteristic: dimension is important as the "lip" must fit flush into part #81550/60-00050-01.

Charts Used: Range and X-Bar

Gage/Device: Mitutoyo Digital Caliper # 25- Return to 5.0

2007-001-A

35
Gage R&R Data Table:

Operator A Operator B Operator C

Sample ID Trial 1 Trial 2 Trial 3 Range Trial 1 Trial 2 Trial 3 Range Trial 1 Trial 2 Trial 3 Range
1 0.497 0.499 0.4975 0.002 0.495 0.495 0.496 0.001 0.495 0.495 0.495 0.000
2 0.5005 0.496 0.496 0.004 0.493 0.495 0.494 0.002 0.495 0.494 0.495 0.001
3 0.5465 0.543 0.546 0.003 0.542 0.542 0.542 0.000 0.543 0.542 0.542 0.001
4 0.545 0.548 0.547 0.003 0.544 0.545 0.544 0.001 0.544 0.543 0.543 0.001
5 0.7905 0.7885 0.788 0.002 0.785 0.785 0.786 0.001 0.783 0.784 0.784 0.001
6 0.7855 0.7855 0.786 0.001 0.786 0.785 0.785 0.001 0.784 0.784 0.784 0.000
7 0.874 0.8775 0.8785 0.004 0.874 0.875 0.874 0.001 0.874 0.874 0.874 0.000
8 0.831 0.8325 0.8325 0.002 0.832 0.829 0.831 0.003 0.828 0.83 0.829 0.002
9 0.689 0.69 0.688 0.002 0.688 0.687 0.689 0.002 0.688 0.687 0.688 0.001
10 0.6415 0.64 0.6415 0.001 0.641 0.64 0.642 0.002 0.64 0.64 0.64 0.000
Trial 1 Trial 2 Trial 3 Trial 1 Trial 2 Trial 3 Trial 1 Trial 2 Trial 3
0.670 0.670 0.670 0.668 0.668 0.668 0.667 0.667 0.667
Trial Averages
Operator A RA Operator B RB Operator C RC
0.670 0.003 0.668 0.001 0.667 0.001
R Average: 0.002 D4: 2.58
Minimum Operator: 0.667
Maximum Operator: 0.670 K1: 3.05
Difference: 0.003
Number of Operators (r): 3 K2: 2.7
No. of Trials (n): 3 Tolerance: 0.02

Return to 5.0

36
Calculations:
Calculate UCL R
UCL R= R Average * D4
0.004

Calculate Equipment Variation (EV) where: Calculate %EV where:

EV = ( R Avg) (K1) %EV= 100[(EV)/(Tolerance)]
EV= 0.00473 %EV= 23.64

Calculate Appraiser Variation (AV) where: Calculate %AV where:

AV = Ö [ (Diff Max-Min)(K2)]² - [(EV)² / (n x r)] % AV = 100 Ö [ (AV) / (Tolerance)]
AV = 0.00715 % AV= 59.80

Calculate R & R Where: Calculate % R & R Where:

R&R = Ö (EV) ²+ (AV) ² % R&R= Ö ( % EV) ²+ (% AV) ²
R&R= 0.00857 % R&R= 64.3039

37
 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.

Point # Data (in mg.)

1 33.58 Run Chart
Weight (in mg)
2 33.49
3 34.18 40
4 35.28
5 34.52
6 34.35
7 33.92 Value
8 35.4
9 34.14
10 34.12 30
11 35.87 1 2 3 4 5 6 7 8 9 10 11 12131415161718192021222324252627282930
12 33.9 Data Point
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
17 33.9 StDev. 0.644
18 35.14 Center Spec 539.9
19 34.62 Cp 2.59
20 34.01 Tolerance 5.0
21 35.62 Cpk 0.97
22 35.17
23 33.98
24 34.74
25 33.8
26 35.24 This capability analysis was for the weight, in milligrams, of Chilco part #81550/60-
27 34.5 00040-00. The weight of the part needs to be between 29.8 and 36.4 mg. Clearly we are
28 35.11
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
29 34
process.

Page 38
 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
5.10
capable (Cp of 2.59) but the Cpk Calculation
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.
30 34.14

Return to 5.0

Page 39