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5.0 SIX SIGMA ANALYSIS Tool Quality Goal Description of Approach Description of Intended Outcomes FMEA Provides FMEA on machining operations. Conduct Gage R&R on lip. Through the Six Sigma analysis, the team aims to understand the sources of variation with the processes within t company and relate those to productivity and profitability. There are three types of information presented in th section: Pareto Analysi 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. Safety Checkli VOC: understand requirements that are critical to safety Assess each element of a safety checklist to determine whether corrective or preventive action is needed. 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. Identify which problems to use other Six Sigma tools on first to achieve desired quality outcome. OPCP Reduce Variation Record processes, control mechanisms, and policies to reestablish control. Understand how variation is controlled at each stage of the production process. Understand what policies are already in place for corrective action. 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. Injection Mold Provides FMEA on injection molding operations. Machining VDGRARS Reduce Variation Understand whether there is an issue with one part in the process, highlighted by previous analysis as a potential source of more variability.

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5.0 SIX SIGMA ANALYSIS

Tool Description of Approach Description of Intended Outcomes

FMEA

Provides FMEA on machining operations.

Conduct Gage R&R on lip.

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:

Quality Goal

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.

Safety Checklist

VOC: understand requirement

s that are critical to

safety

Assess each element of a safety checklist to determine whether corrective or preventive action is needed.

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.

Identify which problems to use other Six Sigma tools on first to achieve desired quality outcome.

OPCP Reduce Variation

Record processes, control mechanisms, and policies to reestablish control.

Understand how variation is controlled at each stage of the production process. Understand what policies are already in place for corrective action.

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.

Injection Molding Provides FMEA on injection molding operations.

Machining

VDGRARS Reduce Variation

Understand whether there is an issue with one part in the process, highlighted by previous analysis as a potential source of more variability.

Note: Click on blue links above to view worksheet.

Cpk Calculation Reduce Variation

Evaluate process capability for one part in Chilco production process.

Determine whether process needs to be adjusted.

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.

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.

5.0 SIX SIGMA ANALYSIS

5.1 PARETO CHARTING

5.1.1 General Directions.

5.1.2 Attribute Table.

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

AttributesGapping 26334 37%Mold Flash 9964 14%Rough Surfaces / Orange Peel 8541 12%Warpage 6406 9%Excessive Shrinkage 2847 4%

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.

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%.

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.

# of Total Occurences

% of Total Occurrence

Gap

ping

Mol

d Fl

ash

Rou

gh S

urfa

ces

/ Ora

nge

Peel

War

page

Exc

essi

ve S

hrin

kage

Mou

ld S

ticki

ng

Bri

ttlen

ess

Low

Glo

ss

Un-

mel

ted

Gra

nule

s

Wea

k W

eldi

ness

Wri

nkle

s

Bro

wn

Stai

ns

Bur

n M

arks

Dis

colo

ratio

n

Dro

olin

g

Shor

t Sho

t

Sink

s / V

oids

Stre

aks

/ Spl

ash

Mar

ks

Flow

Mar

ks /

Jetti

ng

Odo

r

Scre

w S

lippa

ge

0%

5%

10%

15%

20%

25%

30%

35%

40%37%

14%12%

9%

4% 4%3% 3% 2.50% 2% 1.50% 1% 1% 1% 1% 1% 1% 1% 1% 0.50%0.50%

1.4.4 Pareto Chart - Greensboro Quality Issues

Attributes

% o

f Tot

al O

ccur

ence

Return to 5.0

Mould Sticking 2847 4%Brittleness 2135 3%Low Gloss 2135 3%Un-melted Granules 1779 2.50%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%

Attributes Identified, Frequency, % Occurrence. Clinton - Packaging

AttributesFractured Thermoforms 24617 93%Weak Weldiness 1324 5%Discoloration 529 2%

# of Total Occurences

% of Total Occurrence

Gap

ping

Mol

d Fl

ash

Rou

gh S

urfa

ces

/ Ora

nge

Peel

War

page

Exc

essi

ve S

hrin

kage

Mou

ld S

ticki

ng

Bri

ttlen

ess

Low

Glo

ss

Un-

mel

ted

Gra

nule

s

Wea

k W

eldi

ness

Wri

nkle

s

Bro

wn

Stai

ns

Bur

n M

arks

Dis

colo

ratio

n

Dro

olin

g

Shor

t Sho

t

Sink

s / V

oids

Stre

aks

/ Spl

ash

Mar

ks

Flow

Mar

ks /

Jetti

ng

Odo

r

Scre

w S

lippa

ge

0%

5%

10%

15%

20%

25%

30%

35%

40%37%

14%12%

9%

4% 4%3% 3% 2.50% 2% 1.50% 1% 1% 1% 1% 1% 1% 1% 1% 0.50%0.50%

1.4.4 Pareto Chart - Greensboro Quality Issues

Attributes

% o

f Tot

al O

ccur

ence

Frac

ture

d T

herm

ofor

ms

Wea

k W

eldi

ness

Dis

colo

ratio

n

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%93%

5%2%

1.4.4 Pareto Chart - Clinton Quality Issues

Attributes

% o

f Tot

al O

ccur

ence

Return to 5.0

Attributes Identified, Frequency, % Occurrence. Manchurian - Machining

AttributesOut of tolerance 132115 43%Poor finish 60313 21%Burrs 45953 16%Stress cracking 25849 9%

# of Total Occurences

% of Total Occurrence

Frac

ture

d T

herm

ofor

ms

Wea

k W

eldi

ness

Dis

colo

ratio

n

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%93%

5%2%

1.4.4 Pareto Chart - Clinton Quality Issues

Attributes

% o

f Tot

al O

ccur

ence

Out

of

tole

ranc

e

Poor

fin

ish

Bur

rs

Stre

ss c

rack

ing

Impr

oper

han

dlin

g

Dis

colo

ratio

n

Mat

eria

ls0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

43%

21%

16%

9%6%

4%1%

1.4.4 Pareto chart - Manchurian Quality Issues

Attributes

% o

f Tot

al O

ccur

ence

Improper handling 17232 6%Discoloration 11488 4%Materials 2872 1%

Out

of

tole

ranc

e

Poor

fin

ish

Bur

rs

Stre

ss c

rack

ing

Impr

oper

han

dlin

g

Dis

colo

ratio

n

Mat

eria

ls

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

43%

21%

16%

9%6%

4%1%

1.4.4 Pareto chart - Manchurian Quality Issues

Attributes

% o

f Tot

al O

ccur

ence

Gap

ping

Mol

d Fl

ash

Rou

gh S

urfa

ces

/ Ora

nge

Peel

War

page

Exc

essi

ve S

hrin

kage

Mou

ld S

ticki

ng

Bri

ttlen

ess

Low

Glo

ss

Un-

mel

ted

Gra

nule

s

Wea

k W

eldi

ness

Wri

nkle

s

Bro

wn

Stai

ns

Bur

n M

arks

Dis

colo

ratio

n

Dro

olin

g

Shor

t Sho

t

Sink

s / V

oids

Stre

aks

/ Spl

ash

Mar

ks

Flow

Mar

ks /

Jetti

ng

Odo

r

Scre

w S

lippa

ge

0%

5%

10%

15%

20%

25%

30%

35%

40%37%

14%12%

9%

4% 4%3% 3% 2.50% 2% 1.50% 1% 1% 1% 1% 1% 1% 1% 1% 0.50% 0.50%

1.4.4 Pareto Chart - Greensboro Quality Issues

Attributes

% o

f Tot

al O

ccur

ence

Gap

ping

Mol

d Fl

ash

Rou

gh S

urfa

ces

/ Ora

nge

Peel

War

page

Exc

essi

ve S

hrin

kage

Mou

ld S

ticki

ng

Bri

ttlen

ess

Low

Glo

ss

Un-

mel

ted

Gra

nule

s

Wea

k W

eldi

ness

Wri

nkle

s

Bro

wn

Stai

ns

Bur

n M

arks

Dis

colo

ratio

n

Dro

olin

g

Shor

t Sho

t

Sink

s / V

oids

Stre

aks

/ Spl

ash

Mar

ks

Flow

Mar

ks /

Jetti

ng

Odo

r

Scre

w S

lippa

ge

0%

5%

10%

15%

20%

25%

30%

35%

40%37%

14%12%

9%

4% 4%3% 3% 2.50% 2% 1.50% 1% 1% 1% 1% 1% 1% 1% 1% 0.50% 0.50%

1.4.4 Pareto Chart - Greensboro Quality Issues

Attributes

% o

f Tot

al O

ccur

ence

Frac

ture

d T

herm

ofor

ms

Wea

k W

eldi

ness

Dis

colo

ratio

n

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%93%

5%2%

1.4.4 Pareto Chart - Clinton Quality Issues

Attributes

% o

f Tot

al O

ccur

ence

Frac

ture

d T

herm

ofor

ms

Wea

k W

eldi

ness

Dis

colo

ratio

n

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%93%

5%2%

1.4.4 Pareto Chart - Clinton Quality Issues

Attributes

% o

f Tot

al O

ccur

ence

Out

of

tole

ranc

e

Poor

fin

ish

Bur

rs

Stre

ss c

rack

ing

Impr

oper

han

dlin

g

Dis

colo

ratio

n

Mat

eria

ls

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

43%

21%

16%

9%6%

4%1%

1.4.4 Pareto chart - Manchurian Quality Issues

Attributes

% o

f Tot

al O

ccur

ence

Out

of

tole

ranc

e

Poor

fin

ish

Bur

rs

Stre

ss c

rack

ing

Impr

oper

han

dlin

g

Dis

colo

ratio

n

Mat

eria

ls

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

43%

21%

16%

9%6%

4%1%

1.4.4 Pareto chart - Manchurian Quality Issues

Attributes

% o

f Tot

al O

ccur

ence

5.2 SAFETY INSPECTION CHECKLIST

Checklist Item OK Actual Site Explanations/ Action/OtherGeneral Safety

Good Housekeeping/CleanlinessPiling and Storage/Tagging SystemsAisles, Walkways, and ExistsTools And SuppliesLadders And StairsMachinery And EquipmentFloors, Platforms, and RailingsElectrical Fixtures/EquipmentDust, Ventilation, and ExplosivesOverhead Valves, Pipes, MarkingsProtective Clothing/EquipmentWashroom, Lockers, Shower, DelugeUnsafe Practices/Horseplay/SOPsFirst Aid FacilitiesVehicles, Hand and Power TrucksFire Fighting EquipmentGuards And Safety DevicesLighting, Work Tables/AreasGeneral MaintenanceSafety Training, CommunicationCompany/OSHA Standards – ComplyCranes, Hoists, ConveyorsScrap And RubbishOther Items, Circumstances

Machinery InspectionHydraulic CylindersToggle Machine LinkagePlatesSafety BarsScrew DrivesBarrel and Front End

Not Safe

Not App.

HosesPipingHydraulic LeaksSafety GateRear GuardFixed GuardsTop Guards

Safety ProceduresEnvironmental problemsHazardous and dangerous conditionsEquipment safety procedures and devicesHazardous materials handlingUnplanned shutdownEvacuationFirst AidFireLockout/TagoutReporting accidents and spillsHousekeepingJob safety review and checklistHazard Communication StandardPersonal protective equipmentSafety regulations and requirementsSafe use of material handling equipmentPersonal protective equipment

Return to 5.0

5.3 PIE CHART

5.3.1 General Directions

5.3.2 Attribute TableGreensboro Plant

% Frequency

Gapping 26334 37%Mold Flash 9964 14%

8541 12%Warpage 6406 9%

2847 4%Mould Sticking 2847 4%Brittleness 2135 3%Low Gloss 2135 3%Un-melted Granules 1779 3%Weak Weldiness 1423 2%

Attributes/Defects

Number of Products with the

Defect

Rough Surfaces/Orange PeelExcessive Shrinkage

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.

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.

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%

712 1%Flow Marks/Jetting 356 1%Odor 356 1%Screw Slippage 356 1%

Clinton Plant

% Frequency

24617 93%

Streaks/Splash Marks

Attributes/Defects

Number of Products with the

DefectFractured Thermoforms

Gapping46%

Mold Flash18%

Rough Surfaces/Orange Peel15%

Warpage11%

Excessive Shrinkage5%

Mould Sticking5%

Pie Chart Showing Defects & % Frequency

Weak Weldiness 1324 5%Discoloration 529 2%

Beijing Plant

% Frequency

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%

Attributes/Defects

Number of Products with the

Defect

Fractured Thermoforms93%

Weak Weldiness5%

Discoloration2%

Pie Chart Showing Defects & % Frequency

Out of tolerance45%

Poor finish20%

Burrs16%

Stress cracking 9%

Improper handling 6%

Discoloration4%

Materials1%

Pie Chart Showing Defects & % Frequency

Out of tolerance45%

Poor finish20%

Burrs16%

Stress cracking 9%

Improper handling 6%

Discoloration4%

Materials1%

Pie Chart Showing Defects & % Frequency

Return to 5.0

ONGOING PROCESS CONTROL PLAN

5.4 OPCP (ONGOING PROCESS CONTROL PLAN)Customer: Gilcaro Page 1 of 1

Key Contact/Phone: Date(Original): Date(Revision):

Control Plan Number: 2006-12345 Mike Carper 6-Jan-05 12-Apr-06Part Number/Latest Change Level: Core Team: Customer Engineering Approval/Date:

BGSU 5678 682 5/20/2006Part Name/Description: Supplier/Plant Approval/Date: 6/1/2006 Customer Quality Approval/Date:

ABC Housing 6/1/2006Supplier/Plant: Supplier Code: Other Approval/Date: Other Approval/Date:

GBO GBO 789Part Process Name/ Machine, Device, Characteristics Special Methods

Process Operation description Jig, Tools. Char. Product/Process Evaluation Measurement Sample Control Reaction PlanNumber 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. IsolateSOP certify receipts material until disposition

Verification & damage. Reconcile packing is reached. Correctiveslips with PO and action.

invoices2 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 HandlingMachine & work Instructions Supervisor. Initiate

Provide forklift training a corrective action.for materials handlers

SOP to review mat'lprior to use

4 & 5 Machining & Bruno Press 1 Length 759.4 mm +/- 5.0mm Tape measure 1 piece 1st, last & Barcode router & Stop production. InformInjection 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 step2 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 errors2 Label information Bar coded label must reflect " " " " Change label to

the proper part #, serial # reflect the properand 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

a corrective action.9 Store Finished Goods Warehouse / Shipping Area 1 Storage Storage & Preservation Visual All Per Lot Training & shelf guards Notify supervisor. Initiate

corrective action.

Procedure Certified material handlers

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 auditsKnown late deliveries

expeditedDeliveries are tracked- Loading instructions,

Dock audit of paperworkRouter software

changes to notify Prod. Ctrl.

of potential late deliveries

SOP requiring Oper. review of package at dock audit

Bar coded containers are scanned to location

SOP requiring Oper. review of package at dock audit

Monthly inventory of storage location by scans

Prototype Pre- Launch Production

Return to 5.0

Potential Failure Mode and Effects Analysis

(PROCESS FMEA)

Page 20 of 39

5.5 FMEA - INJECTION MOLDINGItem: 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 6/2/2007 (Rev.) 01EFFECTS OF FAILURE ACTION TAKEN

1 RECEIVING - Receive wrong - Will not meet our or cust. 7 Vendor problem/comm. 1 Receiving Insp. 5 35 Nonematerial. specifications. (e.g. color)

- Will not meet our or cust. 8 Vendor problem/comm. 2 Receiving Insp. 2 32 Nonespecifications. (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 Nonespecification. 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 14certification. receipt of mat'l without and approved

certification.-Receiving Insp. -Possible production 5 Receiving resources 1 Outsource Receiving InspOvertime 2 10 Nonebehind 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 12Raw 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 12Raw Material review of mat'l prior to use and approved4 INJECTION Flash Excessive trimming rework 5 Mold misalignment 2 Molds held to close Visual Inspection 2 20 None

MOLDING tolerancePart will not release Damaged part/Mold clean up 4 Improper mold cleaning 3 SOP for mold cleaning 1 12 Nonefrom 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 NoneVisual Insp.

Short Shots Part not to specification 7 Nozzle blockage 1 SOP to clean nozzle ever Visual Insp. 2 14 None10 hours of use.

7 Mat'l feed mechanism jammed 2 SOP to clean feed mech. Visual Insp. 2 28 Noneevery 10 hours of use

7 Feed screw or barrel blockage 1 SOP to purge barrel ever Visual Insp. 2 14 None10 hours of use.

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.

Visually unappealing. 6 Excess moisture. 2 Check humidity. Visual inspection. 2 24 SOP for humidity con6/12/2007 SOP proposed.

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

Excessive Shrinkage Incomplete part. 9 Insufficient mataerial. 1 Increase process pressur 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

FMEA Date (Orig): PROCESS

DESCRIPTION POTENTIAL FAILURE

MODESEV

CLASS

POTENTIAL CAUSES OF FAILURE

OCC

CURRENT CONTROLS Prevention

CURRENT CONTROLS Detection

DET

RPN

RECOMMENDED ACTION

RESP. COMP. DATE

SEV

OCC

DET

RPN

4. Greensboro - Injection Molding attributes

Rough Surfaces / Orange Peel

D5
severity: a ranking from low of 1 to high of 10
G5
occurrence; estimation of likelyhool event will occur; 1 low to 10 high likelyhood.
J5
detectability; ability to detect failure; 1 is almost certain; 10 is absolute uncertainty
K5
risk priority number (RPN); is product of severity, occurrence and detection rankings; RPN = (severity)x(occurrence)x(detection

Potential Failure Mode and Effects Analysis

(PROCESS FMEA)

Page 21 of 39

5.5 FMEA - INJECTION MOLDINGItem: 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 6/2/2007 (Rev.) 01EFFECTS OF FAILURE ACTION TAKEN

FMEA Date (Orig): PROCESS

DESCRIPTION POTENTIAL FAILURE

MODESEV

CLASS

POTENTIAL CAUSES OF FAILURE

OCC

CURRENT CONTROLS Prevention

CURRENT CONTROLS Detection

DET

RPN

RECOMMENDED ACTION

RESP. COMP. DATE

SEV

OCC

DET

RPN

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 temperaVisual inspection. 1 9 None 6/12/2007

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

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

5 INSPECTIONNon 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 28missed at insp. part review at packaging step and approved.

7 Insp. Plan vs. 100% Insp. 1 Insp. Plan Statistically 4 28 NoneSelected

Gage out of Customer gets non-conforming 7 Calibration date expired 1 Gage calibration programInsp SOP requires checking 2 14 Nonecalibration 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 None7 LABELING in container compromised Trending of errors

Increased shipping and production 3 Packaging technician error 2 Random packaging checks 4 24 Nonecosts Trending of errors

Customer aggravation 5 Packaging technician error 1 Random packaging checks 4 20 NoneTrending of errors

D5
severity: a ranking from low of 1 to high of 10
G5
occurrence; estimation of likelyhool event will occur; 1 low to 10 high likelyhood.
J5
detectability; ability to detect failure; 1 is almost certain; 10 is absolute uncertainty
K5
risk priority number (RPN); is product of severity, occurrence and detection rankings; RPN = (severity)x(occurrence)x(detection

Potential Failure Mode and Effects Analysis

(PROCESS FMEA)

Page 22 of 39

5.5 FMEA - INJECTION MOLDINGItem: 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 6/2/2007 (Rev.) 01EFFECTS OF FAILURE ACTION TAKEN

FMEA Date (Orig): PROCESS

DESCRIPTION POTENTIAL FAILURE

MODESEV

CLASS

POTENTIAL CAUSES OF FAILURE

OCC

CURRENT CONTROLS Prevention

CURRENT CONTROLS Detection

DET

RPN

RECOMMENDED ACTION

RESP. COMP. DATE

SEV

OCC

DET

RPN

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

Loss of traceability 6 packaging technician error 1 Labeling software validat Certified packaging tech. 3 18 None8 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 approved9 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 approvedLost 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 scans10 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-training11 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 0tracks progress changes to notify Prod. Ctrl.

of potential late deliveriesEarly 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.

D5
severity: a ranking from low of 1 to high of 10
G5
occurrence; estimation of likelyhool event will occur; 1 low to 10 high likelyhood.
J5
detectability; ability to detect failure; 1 is almost certain; 10 is absolute uncertainty
K5
risk priority number (RPN); is product of severity, occurrence and detection rankings; RPN = (severity)x(occurrence)x(detection

Potential Failure Mode and Effects Analysis

(PROCESS FMEA)

Page 23 of 39

5.5 FMEA - INJECTION MOLDINGItem: 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 6/2/2007 (Rev.) 01EFFECTS OF FAILURE ACTION TAKEN

FMEA Date (Orig): PROCESS

DESCRIPTION POTENTIAL FAILURE

MODESEV

CLASS

POTENTIAL CAUSES OF FAILURE

OCC

CURRENT CONTROLS Prevention

CURRENT CONTROLS Detection

DET

RPN

RECOMMENDED ACTION

RESP. COMP. DATE

SEV

OCC

DET

RPN

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.

D5
severity: a ranking from low of 1 to high of 10
G5
occurrence; estimation of likelyhool event will occur; 1 low to 10 high likelyhood.
J5
detectability; ability to detect failure; 1 is almost certain; 10 is absolute uncertainty
K5
risk priority number (RPN); is product of severity, occurrence and detection rankings; RPN = (severity)x(occurrence)x(detection

5.5 FMEA - MACHININGItem: Machining Operation

Process &/or subprocess: N/A

Core Team: S. Stamm, M. Carper; M. ChandlerEFFECTS OF FAILURE

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

(e.g. dimensional specs.)

- Will not meet our or cust. 8specifications. (e.g. mech. specs.)

- Raw Mat'l not to - Will not meet our or 7specification. cust. specifications.

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

-Receiving Insp. -Possible production 5behind schedule. shutdown

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

Lost Mat'l Production Interruption 5

3 MOVE Damaged Mat'l Damaged mat'l used in mfg. 6Raw Material & finished

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

5 INSPECTION Dimension specifications. Customerrejection.

Will not meet customers 9

PROCESS DESCRIPTION

POTENTIAL FAILURE MODE

SEV

CLASS

4 MACHINING - Manchurian attributes

D5
severity: a ranking from low of 1 to high of 10

specifications. Customerrejection.

Will not meet customers 7specifications. Customerrejection.

Surface finish not Will not meet customers 8to specification specifications. Customer

rejection.

Will not meet customers 7specifications. Customerrejection

Gage out of Customer gets non-conforming 7calibration part

Wrong part is Customer rejection. 7produced / wrong Customer may not have amount of parts. enough to fill orders.

Fractured Thermoform Incorrect no. of parts Ineffective container protection of parts 7

Broken transport containDamage to mold. 8Packaging die cut error asymmetrical package Product not packaged successfully. 6

7 LABELING in container compromised

Increased shipping and production 3costs

Customer aggravation 5

Labeling error Customer aggravation 4

Loss of traceability 68 MOVE Damaged Mat'l Damaged mat'l gets to customer 7

Finished Goods9 STORE Damaged Mat'l Damaged mat'l gets to customer 7

Finished GoodsLost mat'l Customer orders not filled 6

6 PACKAGING - Clinton attributes

Packaging mold defects

10 DOCK AUDIT Customer order not Customer aggravation 4correctly filled

11 SHIPPING Late delivery Custom aggravation and potential 6downtime

6

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.

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.

Machining Operation

Process Responsibility: Manchurian Prod.

Key Date: June 2, 2007

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 21problem

Vendor problem 3 Receiving Insp. 3 63

Not enough receiving 1 Outsource Receiving Insp. Overtime 2 10resources 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 108certification

Improper set-up / 1 training Set-Up Sheet 3 27operator in hurry 2 training Final process steps 2 32O-ring failure; PM issue 2 training Final process steps 2 32Improper set-up / 2 training Final process steps 2 32operator in hurry 1 training Final process steps 2 16Improper set-up / 1 training Final process steps 2 16operator in hurry 1 training Final process steps 3 24

fixturing Inspection at Operation

Wrong program selected 2 Set-Up Sheet 3 54

POTENTIAL CAUSES OF FAILURE

OCC

CURRENT CONTROLS Prevention

CURRENT CONTROLS Detection

DET

RPN

G5
occurrence; estimation of likelyhool event will occur; 1 low to 10 high likelyhood.
J5
detectability; ability to detect failure; 1 is almost certain; 10 is absolute uncertainty
K5
risk priority number (RPN); is product of severity, occurrence and detection rankings; RPN = (severity)x(occurrence)x(detection)

Inspection at Operation

Material variation 1 Specification review with Material certification review 2 14vendor at receiving inspection

Dull tooling 2 Machining prgm. has 2 32tool hr limitations

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

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

Not following Work Inst. 1 Production order/router Product traceability at all 8 56Work 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 8Vendor error. 1 Tooling spec. review with ve Random packaging checks 2 12

Trending of errors

Packaging technician error 2 Random packaging checks 4 24Trending of errors

Packaging technician error 1 Random packaging checks 4 20Trending 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 18Lack of training/awareness 3 Training Certified material handlers 6 126

Damaged by mat'l moving 3 Training & shelf guards Certified material handlers 6 126equipment or techniciansMat'l not stored or moved 1 Bar coded containers are Monthly inventory of 3 18without scanning scanned to location storage location by scans

Dock auditor fatigue or 1 Auditor breaks Dock audit checklist 3 12needing re-trainingLate 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 90tracks progress

Routing mishap 1 Dock audit of paperwork 1 4

FMEA Number: M-001

Prepared by: M. Chandler

6/4/2007 (Rev.) 01ACTION TAKEN

None

None

None

SOP requiring no 6/5/2007 SOP written and 7 2 1 14receipt of mat'l with- approvedout certificationNone

SOP requiring Oper. 6/5/2007 SOP written and 6 2 1 12review of mat'l prior to use approvedNone

SOP requiring Oper. 6/5/2007 SOP written and 6 2 1 12review of mat'l prior to use approved

Schedule PM ###Schedule PM ###Schedule PM ###Schedule PM ###Schedule PM ###Schedule PM ###Schedule PM ###

Bar code router and 12/31/2007

FMEA Date (Orig): RECOMMENDED

ACTIONRESP.

COMP. DATESEV

OCC

DET

RPN

scan at machine toload correct program

None

None

None

None

SOP requiring Oper. 6/5/2007 SOP written and 7 1 2 14review and doc. of product completeidentifiers and quantityat each production step

None

Track as PM.Track as PM.

None

None

None

NoneSOP requiring Oper. 6/5/2007 SOP written and 7 2 1 14review of package at dock audit completeSOP requiring Oper. 6/5/2007 SOP written and 7 2 1 14review of package at dock audit completeNone

None

None

None

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

Return Home

Return Home

35

5.8 VARIABLE DATA GAGE REPRODUCIBILITY & REPEATABILITY SYSTEM (VDGRARS)

Part Description:

Inspection Description:

Operation: Tolerance: 0.02

Characteristic:

Charts Used: Range and X-Bar

Gage/Device:

Injection Molding, operation #0110

Mitutoyo Digital Caliper # 25-2007-001-A

This is a variable gage R&R study of the "lip" dimension of Chilco part number 81550/60-00040-00.

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.

This characteristic measures the "lip" dimension of part #81550/60-00040-00. This dimension is important as the "lip" must fit flush into part #81550/60-00050-01.

Return to 5.0

36

Gage R&R Data Table:

Operator A Operator B Operator CSample 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 0.498 0.002 0.495 0.495 0.496 0.001 0.495 0.495 0.495 0.0002 0.501 0.496 0.496 0.004 0.493 0.495 0.494 0.002 0.495 0.494 0.495 0.0013 0.547 0.543 0.546 0.003 0.542 0.542 0.542 0.000 0.543 0.542 0.542 0.0014 0.545 0.548 0.547 0.003 0.544 0.545 0.544 0.001 0.544 0.543 0.543 0.0015 0.791 0.789 0.788 0.002 0.785 0.785 0.786 0.001 0.783 0.784 0.784 0.0016 0.786 0.786 0.786 0.001 0.786 0.785 0.785 0.001 0.784 0.784 0.784 0.0007 0.874 0.878 0.879 0.004 0.874 0.875 0.874 0.001 0.874 0.874 0.874 0.0008 0.831 0.833 0.833 0.002 0.832 0.829 0.831 0.003 0.828 0.83 0.829 0.0029 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 0.642 0.64 0.642 0.001 0.641 0.64 0.642 0.002 0.64 0.64 0.64 0.000

Trial Averages

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 0.667Operator A RA Operator B RB Operator C RC

0.670 0.003 0.668 0.001 0.667 0.001R Average: 0.002 D4: 2.58Minimum Operator: 0.667Maximum Operator: 0.670 K1: 3.05

Difference: 0.003Number of Operators ( 3 K2: 2.7

No. of Trials (n): 3 Tolerance: 0.02

Return to 5.0

37

Calculations:Calculate UCL RUCL R= R Average * D4

0.004

Calculate Equipment Variation (EV) where: Calculate %EV where: %EV= 100[(EV)/(Tolerance)]

EV= 0.005 %EV= 23.64

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

AV = 0.007 59.80

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

R&R= 0.009 % R&R= 64.3

EV = ( R Avg) (K1)

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

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

5.10 Cpk Calculation

Page 38

5.10 Cpk CalculationDirections :

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 33.582 33.493 34.184 35.285 34.526 34.357 33.928 35.49 34.14

10 34.1211 35.8712 33.913 34.6414 34.5815 35.36 Upper Spec 36.4 Mean 34.51316 34.08 Lower Spec 29.8 Variance 0.4151517 33.9 StDev. 0.64418 35.14 Center Spec 539.919 34.62 Cp 2.5920 34.01 Tolerance 5.021 35.62 Cpk 0.9722 35.1723 33.9824 34.7425 33.826 35.2427 34.528 35.1129 34

1 2 3 4 5 6 7 8 9 10111213141516171819202122232425262728293030

40

Run ChartWeight (in mg)

Data Point

Valu

e

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.

5.10 Cpk Calculation

Page 39

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 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.

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