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Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04 “Spills are not acceptable.” Deep & Wide Process

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Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

“Spills are not acceptable.”

Deep & Wide Process

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Spill Data for GM Suppliers

050

100150200250300350

2000 2001 2002 2003 2004

Year

290

87

149

41 0

Num

ber o

f Spi

lls

Our success depends on your performance!

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Recurrence Prevention Model

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Supplier Quality Model

ProtectQuality process -containment & responsiveness

ProtectQuality process -detection & responsiveness

Plan

Do

Check/Act

PreventManufacturing process -standardized work and

error proofing

PreventManufacturing process -standardized work and

error proofing

PredictPlanning process -

informational content in FMEAs and CPs

PredictPlanning process -

informational content in FMEAs and CPs

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

• Identify Metric & Threshold

• SupplierIdentification

• ToolboxApplication

• Predict(FMEA, PCP)

• Prevent(Error Proofing, STW)

• Protect(Error Detection, Responsiveness)

• IdentifyIssues

• Identify same Process

• Implement Lessons

SQ Recurrence Prevention Model

Build the Base Drill Wide(Read Across)

Drill Deep(3x5Why)

Why did the planning process not predict the defect?

Why did the manufacturing process not prevent the defect?

Why did the quality process not protect GM from the defect?

Problem on part

P1P2

P3P4

PnPredict Root Cause

Why?

Why?

Why?

Why?M1

M2M3

M4Mn

Prevent Root Cause

Why?

Why?

Why?

Why?Q1Q2

Q3Q4

QnProtect Root Cause

Why?

Why?

Why?

Why?

PredictCorrective Action

Prevent Corrective Action

ProtectCorrective Action

IssuesOther Products

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Spills

Emerging Current Issues

Functional BuildIssues

Supplier Process Issues

Plant Issues

EmergingLaunch Issues Prevention

should start here

WideImplementation(Read Across)

Deep Investigation(Drill Deep analysis)

Recurrence Prevention Model

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Spills

Emerging Current Issues

Functional BuildIssues

Supplier Process Issues

Plant Issues

EmergingLaunch Issues

Recurrence Prevention Model

Spills / MDRepeat EIs

Critical Suppliers forPotential Spill

Chronic Suppliers

All Suppliers

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Drill Deep Training

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Drill Deep Analysis• What is the intent of the Drill Deep analysis?

• Why did the planning process not predictthe defect?

• Why did the manufacturing process not prevent the defect?

• Why did the quality process not protect GM from the defect?

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Drill Deep Analysis• Key Points:

• Drill Deep Analysis is not used to understand what failed but rather whythe system failed.

• Therefore, the technical root cause (i.e., the Red X in supplier’s process) should be known before the Drill Deep Worksheet is completed.

• 3 x 5 Why <--> Drill Deep Analysis

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Why did the planning process not predict the defect?

Why did the manufacturing process not prevent the defect?

Why did the quality process not protect GM from the defect?

Defect on Part

P1P2

P3P4

PnPredict Root Cause

Why?

Why?

Why?

Why?M1

M2M3

M4Mn

Prevent Root Cause

Why?

Why?

Why?

Why?Q1Q2

Q3Q4

QnProtect Root Cause

Why?

Why?

Why?

Why?

PredictCorrective Action

Prevent Corrective Action

ProtectCorrective Action

Drill Deep Visual

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Drill Deep Worksheet• GM Form 1927-84

Date: 02/24/04

Issue title:

Customer concern:

Defect on part:

5 Whys Corrective Action Owner Due Date

P1 RPN number was not determined properly in PFMEA.

P2 Occurrence and detection ratings were not determined properly.

P3

P4

P5

P-RC Inadequate knowledge of FMEA methodology.

FMEA training plan to be developed and monthly FMEA layered audit review to be implemented.

J. Smith 03/15/04

M1 Cylinder did not travel to full insertion.

M2Positive stops were not adjusted correctly for the new, low permeation family insert.

M3Control Plan was not updated to indicate recalibration for new family insert.

M4 Manufacturing was not aware of a new family insert.

M5Poor communication between Product Development & Manufacturing on design change.

M-RC Supplier XYZ Launch Planning System was not followed.

Re-train employees and implement a layered audit of planning process. J. Smith 03/31/04

Q1 No detection error-proofing for "end cap fully seated".

Q2

Q3

Q4

Q5

Q-RCFalse sense of security in error proofing prevention of positive stops in tooling.

Re-evaluate prevention error-proofing process and implement detection error-proofing process.

J. Smith 03/15/04

K1 Engineering change management execution.

Develop regular change control meetings with entire team. J. Smith 03/31/04

K2 PPAP / PTR execution. Develop Supplier Change Request audit process. J. Smith 03/31/04

K3 Insufficient error-proofing incorporated into valve assembly.

Re-evaluate prevention error-proofing process and implement detection error-proofing process.

J. Smith 03/31/04

K4 Inadequate knowledge of FMEA methodology.

FMEA training plan to be developed and monthly FMEA layered audit review to be implemented.

J. Smith 03/15/04

K5

Why did the manufacturing process not prevent the defect?

Why did the quality process not protect GM from the defect?

What are the key findings based on this quality issue and the above 5

Why analysis?

Drill Deep Worksheet

Product XYZ Fuel Tank Rollover Valve Assembly

End cap not fully seated into window on valve.

Why did the planning process not predict the defect?

Loose parts found in Product XYZ fuel tanks. PRR# 30011223-989898.

PredictPlanning process -

informat ional cont ent in FMEAs and CPs

PredictPlanning process -

informat ional cont ent in FMEAs and CPs

PreventM anufacturing process -st andardized w ork and

error proof ing

PreventM anufacturing process -st andardized w ork and

error proof ing

ProtectQualit y process -

detect ion & responsiveness

ProtectQualit y process -

detect ion & responsiveness

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

5 Whys Corrective Action Owner Due Date

M1 Cylinder did not travel to full insertion.

M2Positive stops were not adjusted correctly for the new, low permeation family insert.

M3Control Plan was not updated to indicate recalibration for new family insert.

M4 Manufacturing was not aware of a new family insert.

M5Poor communication between Product Development & Manufacturing on design change.

M-RC Supplier XYZ Launch Planning System was not followed.

Re-train employees and implement a layered audit of planning process. J. Smith 03/31/04

Why did the manufacturing process not prevent the defect?

PreventManufacturing process -standardized w ork and

error proof ing

PreventManufacturing process -standardized w ork and

error proof ing

Drill Deep WorksheetOnly add a corrective action next to each "Why" if applicable. Keep in mind that the last "Why" needs a corrective action with an owner and a completion date.

Also, there can be more than one corrective action for a root cause and the corrective action should include some form of verification or "Check".

Adjust row height as necessary.

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Drill Deep Worksheet

Insert owner for implementing each corrective action.

Insert due date for implementing each corrective action.

Format MM/DD/YY.

5 Whys Corrective Action Owner Due Date

M1 Cylinder did not travel to full insertion.

M2Positive stops were not adjusted correctly for the new, low permeation family insert.

M3Control Plan was not updated to indicate recalibration for new family insert.

M4 Manufacturing was not aware of a new family insert.

M5Poor communication between Product Development & Manufacturing on design change.

M-RC Supplier XYZ Launch Planning System was not followed.

Re-train employees and implement a layered audit of planning process. J. Smith 03/31/04

Why did the manufacturing process not prevent the defect?

PreventManufacturing process -standardized w ork and

error proof ing

PreventManufacturing process -standardized w ork and

error proof ing

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

5 Whys Corrective Action Owner Due Date

M1 Cylinder did not travel to full insertion.

M2Positive stops were not adjusted correctly for the new, low permeation family insert.

M3Control Plan was not updated to indicate recalibration for new family insert.

M4 Manufacturing was not aware of a new family insert.

M5Poor communication between Product Development & Manufacturing on design change.

M-RC Supplier XYZ Launch Planning System was not followed.

Re-train employees and implement a layered audit of planning process. J. Smith 03/31/04

Why did the manufacturing process not prevent the defect?

PreventManufacturing process -standardized w ork and

error proof ing

PreventManufacturing process -standardized w ork and

error proof ing

Drill Deep Worksheet

Why?

Why?

Why?

Why?

Why?

Enter each why below. Insert a row for each additional why if applicable.

As a sense check, read the Whys backwards to make sure that the analysis make “sense”.

Adjust row height as necessary.

Perform the 5 Why to the right. The first question to ask and answer to begin the Prevent 5 Why is the following:

Why did the manufacturing process not prevent the defect?

Example:

Why did the manufacturing process not prevent the end cap not fully seated into window on the valve?

Why?

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

5 Whys Corrective Action Owner Due Date

M1 Cylinder did not travel to full insertion.

M2Positive stops were not adjusted correctly for the new, low permeation family insert.

M3Control Plan was not updated to indicate recalibration for new family insert.

M4 Manufacturing was not aware of a new family insert.

M5Poor communication between Product Development & Manufacturing on design change.

M-RC Supplier XYZ Launch Planning System was not followed.

Re-train employees and implement a layered audit of planning process. J. Smith 03/31/04

Why did the manufacturing process not prevent the defect?

PreventManufacturing process -standardized w ork and

error proof ing

PreventManufacturing process -standardized w ork and

error proof ing

Drill Deep WorksheetEnter each why below. Insert a row for each additional why if applicable.

As a sense check, read the Whys backwards to make sure that the analysis make “sense”.

Adjust row height as necessary.

Therefore. . .Therefore. .

.Therefore. .

.Therefore. .

.Therefore. .

.

Perform the 5 Why to the right. The first question to ask and answer to begin the Prevent 5 Why is the following:

Why did the manufacturing process not prevent the defect?

Example:

Why did the manufacturing process not prevent the end cap not fully seated into window on the valve?

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

5 Whys Corrective Action Owner Due Date

M1 Cylinder did not travel to full insertion.

M2Positive stops were not adjusted correctly for the new, low permeation family insert.

M3Control Plan was not updated to indicate recalibration for new family insert.

M4 Manufacturing was not aware of a new family insert.

M5Poor communication between Product Development & Manufacturing on design change.

M-RC Supplier XYZ Launch Planning System was not followed.

Re-train employees and implement a layered audit of planning process. J. Smith 03/31/04

Why did the manufacturing process not prevent the defect?

PreventManufacturing process -standardized w ork and

error proof ing

PreventManufacturing process -standardized w ork and

error proof ing

Drill Deep WorksheetAlso, keep in mind that the technical root cause (i.e., Red X in supplier’s process) should be captured in the Prevent 5 Why as shown below.

The last "why" is the underlying Root Cause. Please add a corrective action, owner, and date to the right.

Does not have to be 5 Whys - ask as many Whys as necessary.

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

5 Whys Corrective Action Owner Due Date

P1 RPN number was not determined properly in PFMEA.

P2 Occurrence and detection ratings were not determined properly.

P3

P4

P5

P-RC Inadequate knowledge of FMEA methodology.

FMEA training plan to be developed and monthly FMEA layered audit review to be implemented.

J. Smith 03/15/04

Why did the planning process not predict the defect?

PredictPlanning process -

informat ional content in FMEAs and CPs

PredictPlanning process -

informat ional content in FMEAs and CPs

Drill Deep Worksheet

Why?

Why?

Similar question can be asked for the Predict portion:

Why did the planning process not predict the defect?

Example:

Why did the planning process not predict the end cap not fully seated into window on the valve?

Why?Therefore. .

. Therefore. .

.

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Q1 No detection error-proofing for "end cap fully seated".

Q2

Q3

Q4

Q5

Q-RCFalse sense of security in error proofing prevention of positive stops in tooling.

Re-evaluate prevention error-proofing process and implement detection error-proofing process.

J. Smith 03/15/04

Why did the quality process not protect GM from the defect?

ProtectQualit y process -

detect ion & responsiveness

ProtectQualit y process -

detect ion & responsiveness

Drill Deep Worksheet

Why?

Similar question can be asked for the Protect portion:

Why did the quality process not protect GM from the defect?

Example:

Why did the quality process not protect GM from the end cap not fully seated into window on the valve?

Why?

Therefore. . .

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Drill Deep Worksheet

K1 Engineering change management execution.

Develop regular change control meetings with entire team. J. Smith 03/31/04

K2 PPAP / PTR execution. Develop Supplier Change Request audit process. J. Smith 03/31/04

K3 Insufficient error-proofing incorporated into valve assembly.

Re-evaluate prevention error-proofing process and implement detection error-proofing process.

J. Smith 03/31/04

K4 Inadequate knowledge of FMEA methodology.

FMEA training plan to be developed and monthly FMEA layered audit review to be implemented.

J. Smith 03/15/04

K5

What are the key findings based on this quality issue and the above 5

Why analysis?

Are there any other key findings? Review the 5 Why analysis above to uncover any common “themes” and document them to the right.

A corrective action, owner, and date needs to be added for each key finding.

Adjust row as necessary.

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Drill Deep WorksheetDate: 02/24/04

Issue title:

Customer concern:

Defect on part:

5 Whys Corrective Action Owner Due Date

P1 RPN number was not determined properly in PFMEA.

P2 Occurrence and detection ratings were not determined properly.

P3

P4

P5

P-RC Inadequate knowledge of FMEA methodology.

FMEA training plan to be developed and monthly FMEA layered audit review to be implemented.

J. Smith 03/15/04

M1 Cylinder did not travel to full insertion.

M2Positive stops were not adjusted correctly for the new, low permeation family insert.

M3Control Plan was not updated to indicate recalibration for new family insert.

M4 Manufacturing was not aware of a new family insert.

M5Poor communication between Product Development & Manufacturing on design change.

M-RC Supplier XYZ Launch Planning System was not followed.

Re-train employees and implement a layered audit of planning process. J. Smith 03/31/04

Q1 No detection error-proofing for "end cap fully seated".

Q2

Q3

Q4

Q5

Q-RCFalse sense of security in error proofing prevention of positive stops in tooling.

Re-evaluate prevention error-proofing process and implement detection error-proofing process.

J. Smith 03/15/04

K1 Engineering change management execution.

Develop regular change control meetings with entire team. J. Smith 03/31/04

K2 PPAP / PTR execution. Develop Supplier Change Request audit process. J. Smith 03/31/04

K3 Insufficient error-proofing incorporated into valve assembly.

Re-evaluate prevention error-proofing process and implement detection error-proofing process.

J. Smith 03/31/04

K4 Inadequate knowledge of FMEA methodology.

FMEA training plan to be developed and monthly FMEA layered audit review to be implemented.

J. Smith 03/15/04

K5

Why did the manufacturing process not prevent the defect?

Why did the quality process not protect GM from the defect?

What are the key findings based on this quality issue and the above 5

Why analysis?

Drill Deep Worksheet

Product XYZ Fuel Tank Rollover Valve Assembly

End cap not fully seated into window on valve.

Why did the planning process not predict the defect?

Loose parts found in Product XYZ fuel tanks. PRR# 30011223-989898.

PredictPlanning process -

informat ional content in FMEAs and CPs

PredictPlanning process -

informat ional content in FMEAs and CPs

PreventM anufacturing process -standardized w ork and

error proof ing

PreventM anufacturing process -standardized w ork and

error proof ing

ProtectQualit y process -

detect ion & responsiveness

ProtectQualit y process -

detect ion & responsiveness

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Drill Deep Summary• Drill Deep Analysis is not used to

understand what failed but why the system failed.

• Technical root cause (i.e., the Red X in supplier’s process) should be known before the Drill Deep Worksheet is competed.

• 3 x 5 Why <--> Drill Deep Analysis.

• t + T + E+ = S

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Read Across Training

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Read Across Matrix (Drill Wide)

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Record the GM Owner (I.e. Supplier Process Development Metallic, Chemical, Electrical) or CS2 Provider name and information.

Record the Supplier Information

For CS2 provider only

Read Across Work Instructions

SUPPLIER: PQE/SQE:Name: XYZ Corporation

Location: SpringfieldDuns: 12345789

Contact Name: John Doe Contact Phone:Contact Phone: 123-555-1212

E-mail: [email protected]

Eight Week Period:

E-mail:

Due Date:

Name:Phone:GM location / Provider

Jane Quality

321-555-1212

[email protected]

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

O

XR

N/A

Original Location

Another Location which contains the same process

Repeat IssuesNot Applicable

Completed & 3rd Party/GM verified

Completed & Supplier verified onlyNot Completed

Mark with an “O” for the Originating location

LEGEND

Mark with an “X” all locations where the defect may occur

Mark with an “R” if the problem was repeated at another location

Place a letter in each box for each line item that applies

Color code each box that has a letter in it according to this scheme

Read Across Work Instructions

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Part Name &

NumberGM Assy.

Plant Customer Concern Defect on Part 5 Why Analysis

Part Name & Number

GM Assy. Plant Customer Concern Defect on Part 5 Why Analysis

WidgetModule

22609999Florida Knob not secure 1/3/2004Knob shy

Record the Part Name and full Part Number

Record the PRR issuing location

Record the issue as described by the plant

Create one line for each PRR issuedRecord the Date the Drill Deep AnalysisWas completed

Record the DEFECT on the part

Read Across Work Instructions

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Record the full PRR number

Record the number of non conforming parts Identified on the PRR

Identify the Type and Status of any Controlled Shipping action initiatedas a result of this PRR

Identify the CorporateChampion responsible to ensure implementation of the corrective actions

Read Across Work Instructions

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Identify all supplier DUNS locations with similar products and processes

Identify all lines within each duns where correctiveactions may apply.Also identify newProducts to apply Lessons Learned.

Use letter code withappropriate color toidentify applicable locations and status

Read Across Work Instructions

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Root Cause Pareto

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Root Cause MatrixPRR Predict

(Planning Procces)Prevent

(Manufacturing Process)

Protect(Quality Process)

Key Findings

120030805-000001 FMEA - corrective actions

ineffective Assembly - not connected No detection

220030806-000002 FMEA - corrective actions

ineffective Assembly - not connected No detection

320030807-000003 Poor validation - design,

FMEA - not included No detection Poor validation - design

420030807-000004 Poor validation - design,

FMEA - not included No detection Poor validation - design

520030811-000005

FMEA - detection too low Assembly - JI not followed No detection

6

20030811-000006 Poor validation - design, FMEA - not included No detection Poor validation - design

7

20030813-000007

FMEA - occurrence too lowAssembly - part

backwards, JI not followed No detection

820030819-000008 FMEA - corrective actions

ineffectiveAssembly - dropped

screw No detection

9

20030821-000009 Poor validation - pack, FMEA - not included Packaging

No detection - occurs after pack Poor validation - pack

10

20030821-000010 Poor validation - design, FMEA - not included No detection Poor validation - design

1120030822-000011

FMEA - not includedRepair procedure not

followed No detection

12 20030825-000012 Procedure - repair

13 20030826-000013 FMEA - detection too low Error proofing fault

1420030829-000014

Validation - pack PackagingNo detection - occurs after

pack

Transfer the Root Causes for Predict,Prevent and Protect from the 3x5 DrillDeep Worksheets to this form.

Include any Key Findings

Include all PRRs

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Predict Planning Process

PreventManufacturing Process

ProtectQuality Process Key Findings

FMEA - corrective actions ineffective

Work Instructionnot followed Measurement/CP Poor validation - design

FMEA - corrective actions ineffective Assembly - dropped screw No checks in CP Poor design

FMEA - corrective actions ineffective Assembly - dropped screw No controls Poor design validation

FMEA - corrective actions ineffective Assembly - dropped screw

No controls - latent, caused in vehicle Poor validation - design

FMEA - corrective actions ineffective Assembly - JI not followed No inspection Poor validation - design

FMEA - corrective actions ineffective Assembly - JI not followed Poor controls Poor validation - design

FMEA - corrective actions ineffective Assembly - JI not followed Poor measurement Poor validation - design

Assembly - missing parts Poor validation - design

FMEA - detection too low Assembly - not connected No detection

FMEA - detection too low Assembly - not connected No detection

FMEA - detection too lowAssembly - part backwards, JI

not followed No detection

FMEA - detection too lowAssembly - part dropped and

mishandled No detection

FMEA - detection too lowAssembly - tape in wrong

position No detection

FMEA - detection too lowAssembly - wrong part, material

handling location wrong No detection

Group Like Root Causes and Key Findings within eachColumn. Account for all PRRs

Root Causes Grouped

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

PredictPlanning Process

PreventManufacturing Process

ProtectQuality Process Key Findings

FMEA - corrective actions ineffective

Work Instructionnot followed Measurement/ CP Poor validation - design

FMEA - correct ive act ions inef fect ive Assembly - dropped screw No checks in CP Poor designFMEA - correct ive act ions inef fect ive Assembly - dropped screw No controls Poor design validat ionFMEA - correct ive act ions inef fect ive Assembly - dropped screw No controls - latent , caused in vehicle Poor validat ion - designFMEA - correct ive act ions inef fect ive Assembly - JI not followed No inspect ion Poor validat ion - designFMEA - correct ive act ions inef fect ive Assembly - JI not followed Poor controls Poor validat ion - designFMEA - correct ive act ions inef fect ive Assembly - JI not followed Poor measurement Poor validat ion - design

Assembly - missing parts Poor validat ion - designFMEA - detection too low Assembly - not connected No detection

FMEA - detect ion too low Assembly - not connected No detect ionFMEA - detect ion too low Assembly - part backwards, JI not followed No detect ionFMEA - detect ion too low Assembly - part dropped and mishandled No detect ionFMEA - detect ion too low Assembly - tape in wrong posit ion No detect ionFMEA - detect ion too low Assembly - wrong part , material handling locat ion wrong No detect ionFMEA - detect ion too low No detect ionFMEA - detect ion too low Machine Set Up/ PM No detect ionFMEA - detect ion too low Excessive solder, no PM No detect ion

Incorrect set up of tester No detect ionFMEA - not included Insuf f icient solder due to poor wash No detect ion

FMEA - not included Machine cycle interupted No detect ionFMEA - not included No detect ionFMEA - not included Material Handling No detect ionFMEA - not included Material Handling - damage due to rack design No detect ionFMEA - not included Material Handling - nonconforming product mishandled No detect ionFMEA - not included Poor Material Handling No detect ionFMEA - not included Poor Material Handling No detect ionFMEA - not included Material Handling process not followed No detect ionFMEA - not included No detect ion methodFMEA - not included Packaging No detect ion, no visual controlsFMEA - not included Packaging No detect ionFMEA - not included PackagingFMEA - not included Packaging No detection - occurs after packFMEA - not included Packaging No detect ion - occurs af ter packFMEA - not included No detect ion - occurs af ter packFMEA - not included Procedures No detect ion - occurs af ter packFMEA - not included Procedure - mishandlingFMEA - not included Procedure - repairFMEA-not included Procedure - repair Visual inspectionFMEA - not included Procedure not followed Visual inspect ion

Procedure not followed Visual inspect ionFMEA - occurrence too low Repair procedure not followed Visual inspect ion

FMEA - occurrence too low Visual inspect ionFMEA - occurrence too lowFMEA - occurrence too low

Root Causes Grouped

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Predict PreventPlanning / Documentation Manufacturing Process

RC 3 7 RC 1 6RC 5 5 RC 5 4RC 4 4 RC 2 2RC 2 2 RC 3 1RC 1 1 RC 4 1

Manufacturing System

0 2 4 6 8

RC 1

RC 5

RC 2

RC 3

RC 4

Planning / Documentation

0 1 2 3 4 5 6 7 8

RC 3

RC 5

RC 4

RC 2

RC 1

Insert the Root Cause and the frequencyFor all Groups from the previous Worksheet

The charts will automatically be generated

Root Cause Pareto Charts

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Protect Key FindingsQuality System

RC 5 3 RC 1 4RC 1 2 RC 3 2RC 2 1 RC 2 1RC 3 1RC 4 1

Quality System

0 1 2 3 4

RC 5

RC 1

RC 2

RC 3

RC 4

Key Findings

0 1 2 3 4 5

RC 1

RC 3

RC 2

Repeat, to create the Protect and Key Findings Charts

Root Cause Pareto Charts

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Predict Prevent

Protect KeyKey Findings

0 2 4 6 8

Poor validation - design

Manufacturing System

0 5 10 15

WorkInstruction

not follow ed

Procedures

MaterialHandling

Machine SetUp/ PM

Packaging

Planning / Documentation

0 5 10 15 20 25

FMEA - not included

FMEA - detection toolow

FMEA - correctiveactions ineffective

FMEA - occurrence toolow

Quality System

0 5 10 15 20 25

No detection

Measurement/CP

Visualinspection

No detection -occurs after

pack

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Systemic Issues Read Across

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Systemic Issues Read Across

Supplier Name O Original Product Line and LocationLocation X Product Line and Location with Similar Process

N/A Not ApplicableComplete and 3rd party / VerifiedComplete & Supplier Verified OnlyNot Completed

Issue Corrective Actions Champion Due Date

Plan

t 1

Plan

t 2

Plan

t 3

Plan

t 4

Plan

t 5

Key Findings

Predict

Prevent

Protect

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Predict Prevent

Protect KeyKey Findings

0 2 4 6 8

Poor validation - design

Manufacturing System

0 5 10 15

WorkInstruction

not follow ed

Procedures

MaterialHandling

Machine SetUp/ PM

Packaging

Planning / Documentation

0 5 10 15 20 25

FMEA - not included

FMEA - detection toolow

FMEA - correctiveactions ineffective

FMEA - occurrence toolow

Quality System

0 5 10 15 20 25

No detection

Measurement/CP

Visualinspection

No detection -occurs after

pack

The TOP Bar of each Pareto represents the Systemic Issues whichwill require an initialRead Across

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Systemic Issues RA Example

Supplier Name XYZ Corporation O Original Product Line and LocationLocation Springfield, ZX X Product Line and Location with Similar Process

N/A Not ApplicableComplete and 3rd party / VerifiedComplete & Supplier Verified OnlyNot Completed

Issue Corrective Actions Champion Due Date

Pla

nt 1

Pla

nt 2

Pla

nt 5

Key Findings

Departmental Review, On-line workshopFailure Mode Not Included

Work Instructions not Followed

No Error Detection

Cross training matrix

Develop plan to add error detection to new

N/Cs

Poor Validation/DesignPeer Reviews and

Standardizes Validation Plan

Doe 2/30/04 O x

Doe

Doe

Doe

2/30/04

2/30/04

2/30/04

O x x

O x x

O x x

x

Predict

Prevent

Protect

Supplier identification

The highest frequency root causefrom each Pareto chart is transferred here.Include the Key Finding

Assign a Champion and record a due date

Read Across to Each Plan

Define the Corrective Actions for each Systemic Issue

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Deep & Wide Workshop

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Spill Prevention Workshop

Purpose: Process to teach the supplier the purpose and method of deep

investigation of known quality issues and wide implementation of

lessons learned in order to prevent spills.

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

Prework:•Teach key person at the supplier the Drill Deep concept•Select 25 PRRs or quantity issued in the last 12 months •SQE and Supplier complete the Drill Deep for 25 PRRs•Choose 3 to teach Drill Deep and read across in workshop (representative failure mode and good for read across)•Complete an initial read across for selected PRRs•Complete the root cause matrix (including the other 22 PRRs)

Workshop:•Go through the presentation material•Work one Drill Deep in detail and review two Drill Deep with team•Review the read across for all three PRRs•Group the root causes for all PRRs•Complete the 4 root cause pareto charts (predict, prevent, protect & key findings) •Start the systemic issues read these across•Confirm the workshop deliverables were met and review follow-up items

Roadmap

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

PRR List / Issues (25 or 12 months)

Perform Drill Deep Analysis on all Issues

PREDICTRoot Causes

PREVENTRoot Causes

PROTECTRoot Causes

Group & ParetoAll Root Causes

Group & ParetoAll Root Causes

Group & ParetoAll Root Causes

Implement Corrective Action for individual PRR and Read Across

Implement Corrective Action for Systemic Issues and Read Across

Key FindingsRoot Causes

Group & ParetoAll Root Causes

Workshop Flow Chart

Drill Deep & Wide Workshop Training 5.0 Revision 5.0 03/08/04

• Review Completed Read Across for individual PRRs

• Review Completed Systemic Issue Read Across

• Regular review of PRR Read Across and Systemic Read Across Matrix for Implementation Completion

Workshop Follow-Up