004Drill Deep & Wide Workshop Training 6.0-2

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Drill Deep & Wide Workshop Training 5.0 Rev ision 5.0 03/08/04 1 “Spills are not acceptable.” Deep & Wide Process

Transcript of 004Drill Deep & Wide Workshop Training 6.0-2

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

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“Spills are not acceptable.”

Deep & Wide Process

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

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Date: March 2, 2004To: All General Motors’ Outside Suppliers in North AmericaSubject: 2004 Spill Prevention Communication  General Motors is continuing its quest to be the Global Leader for automotive products and services, and specific to our business, initial quality and reliability by 2005 and 2006 respectively. We can only become successful with you, our Outside Suppliers. Therefore, in compliment to General Motors Zero Tolerance policy, the following enhancements are effective immediately: ·      Those Outside Suppliers that had a Quality Spill in 2003CY or 2004CY will require completion of Drill Deep & Wide and Quality System Basics Workshops. ·      Those Outside Suppliers that GM categorizes as Critical will require completion of a Drill Deep & Wide Workshop and may require completion of a Quality System Basics Workshop. ·      For those Outside Suppliers categorized as Spill or Critical, any Quality PRR (Quality, Warranty, Customer Satisfaction) that results in a Controlled Shipping Level 2, will require a Quality System Basics Workshop or Audit. ·      All Outside Suppliers on Controlled Shipping Level 2 must complete a Drill Deep & Wide Analysis on PRRs issued during the last 8 weeks as well as on any open PRRs regardless of issue date. The purpose is to ensure corrective actions are implemented and verified across the organization. ·      All PRRs need to have Drill Deep Worksheet and Read Across Matrix completed and attached to the PRR for closure. Please reference GP5 and the following Drill Deep and Wide folder in SupplyPower: https://www.gmsupplypower.com/apps/supplypower/NASApp/spcds/CDSRetrieval?lob=quality&subnav=library&togglefolder=16162  In case of questions please reference the above, contact your respective Supplier Quality Engineer, or email your questions to [email protected] . Sincerely,  Michael J. WolfWWP Executive DirectorSupplier Quality & Development 

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• 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

P1

P2

P3

P4

Pn

Predict Root Cause

Why?

Why?

Why?

Why?M1

M2

M3

M4

Mn

Prevent Root Cause

Why?

Why?

Why?

Why?Q1

Q2

Q3

Q4

Qn

Protect Root Cause

Why?

Why?

Why?

Why?

PredictCorrective Action

Prevent Corrective Action

ProtectCorrective Action

IssuesOther Products

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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

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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

P3

P4

Pn

Predict Root Cause

Why?

Why?

Why?

Why?M1

M2

M3

M4

Mn

Prevent Root Cause

Why?

Why?

Why?

Why?Q1Q2

Q3

Q4

Qn

Protect Root Cause

Why?

Why?

Why?

Why?

PredictCorrective Action

Prevent Corrective Action

ProtectCorrective Action

Drill Deep Visual

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Read Across Matrix (Drill Wide)

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Identify issues (PRRs, Scrap, FTQ, etc.)Identify same products/processes

Check Implementatio

n

Implement Lessons Learned

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Drill Deep Analysis

•What is the intent of the Drill Deep analysis?

•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?

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Drill Deep Analysis

•How is the Drill Deep analysis structured?•Supplier Quality Model

•5 Whys

•Action plans

ProtectQuality process -

detection & 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

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

P1

P2

P3

P4

Pn

Predict Root Cause

Why?

Why?

Why?

Why?M1

M2

M3

M4

Mn

Prevent Root Cause

Why?

Why?

Why?

Why?Q1

Q2

Q3

Q4

Qn

Protect Root Cause

Why?

Why?

Why?

Why?

PredictCorrective Action

Prevent Corrective Action

ProtectCorrective Action

5 Whys Corrective Action Owner Due Date

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Drill Deep Analysis

•Key Points:

•Drill Deep Analysis is not used to understand what failed but rather why the 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

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Drill Deep Worksheet

•GM Form 1927-84D ate : 02 /24 /04

Issue title :

C us tom er conce rn :

D e fec t on pa rt:

5 W hys C orrec tive A c tion O w ner D ue D a te

P 1R P N num ber w as no t de te rm ined p rope rly in P F M E A .

P 2O ccu rrence and de tec tion ra tings w ere no t de te rm ined p rope rly.

P 3

P 4

P 5

P -R CInadequa te k now ledge o f F M E A m e thodo logy.

F M E A tra in ing p lan to be deve loped and m on th ly F M E A laye red aud it rev iew to be im p lem en ted .

J . S m ith 03 /15 /04

M 1 C ylinde r d id no t trave l to fu ll inse rtion .

M 2P os itive s tops w ere no t ad jus ted co rrec tly fo r the new , low pe rm ea tion fam ily inse rt.

M 3C on tro l P lan w as no t upda ted to ind ica te reca lib ra tion fo r new fam ily inse rt.

M 4M anu fac tu ring w as no t aw are o f a new fam ily inse rt.

M 5P oor com m un ica tion be tw een P roduc t D eve lopm en t & M anu fac tu ring on des ign change .

M -R CS upp lie r X Y Z Launch P lann ing S ys tem w as no t fo llow ed .

R e-tra in em p loyees and im p lem en t a laye red aud it o f p lann ing p rocess .

J . S m ith 03 /31 /04

Q 1N o de tec tion e rro r-p roo fing fo r "end cap fu lly sea ted ".

Q 2

Q 3

Q 4

Q 5

Q -R CF a lse sense o f secu rity in e rro r p roo fing p reven tion o f pos itive s tops in too ling .

R e-eva lua te p reven tion e rro r-p roo fing p rocess and im p lem en t de tec tion e rro r-p roo fing p rocess .

J . S m ith 03 /15 /04

K 1E ng inee ring change m anagem en t execu tion .

D eve lop regu la r change con tro l m ee tings w ith en tire team .

J . S m ith 03 /31 /04

K 2 P P A P / P T R execu tion .D eve lop S upp lie r C hange R eques t aud it p rocess .

J . S m ith 03 /31 /04

K 3Insu ffic ien t e rro r-p roo fing inco rpo ra ted in to va lve assem b ly.

R e -eva lua te p reven tion e rro r-p roo fing p rocess and im p lem en t de tec tion e rro r-p roo fing p rocess .

J . S m ith 03 /31 /04

K 4Inadequa te k now ledge o f F M E A m e thodo logy.

F M E A tra in ing p lan to be deve loped and m on th ly F M E A laye red aud it rev iew to be im p lem en ted .

J . S m ith 03 /15 /04

K 5

W hy d id the m anu fac tu ring p rocess no t p reven t the de fec t?

W hy d id the qua lity p rocess no t p ro tec t G M from the de fec t?

W ha t a re the k ey find ings based on th is qua lity issue and the above 5

W hy ana lys is?

D rill D eep W o rksh ee t

P roduc t X Y Z F ue l T ank R o llove r V a lve A ssem b ly

E nd cap no t fu lly sea ted in to w indow on va lve .

W hy d id the p lann ing p rocess no t p red ic t the de fec t?

Loose pa rts found in P roduc t X Y Z fue l tank s . P R R # 30011223-989898 .

Pred ictPlan n in g process -

in fo rm at ion al con ten t in FM EA s an d CPs

Pred ictPlan n in g process -

in fo rm at ion al con ten t in FM EA s an d CPs

Preven tM an u factu r in g process -stan dard ized w ork an d

erro r p roofi n g

Preven tM an u factu r in g process -stan dard ized w ork an d

erro r p roofi n g

Pro tectQ uality process -

detection & responsiveness

Pro tectQ uality process -

detection & responsiveness

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Date: 02/24/04

Issue title:

Customer concern:

Defect on part:

Drill Deep Worksheet

Product XYZ Fuel Tank Rollover Valve Assembly

End cap not fully seated into window on valve.

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

Drill Deep Worksheet

Enter date as:

MM/DD/YY

Insert title of quality concern - be short and descriptive.

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Date: 02/24/04

Issue title:

Customer concern:

Defect on part:

Drill Deep Worksheet

Product XYZ Fuel Tank Rollover Valve Assembly

End cap not fully seated into window on valve.

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

Drill Deep Worksheet

Describe the problem the customer experienced; i.e., viewpoint of GM operator at the Assembly Plant.

Include PRR#, PRTS#, 24hr CDP# as applicable.

Examples: Operator could not install O2 sensor on exhaust system; Operator found loose parts in Product XYZ fuel tanks, etc.

Adjust row height as necessary.

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Drill Deep Worksheet

Describe the nonconformance on the part.

Example: End cap not fully seated into window on valve; O2 sensor bung missing on exhaust system; No weld on terminals in relay; Cold weld on brake pedal bracket, etc.

Adjust row height as necessary.

Date: 02/24/04

Issue title:

Customer concern:

Defect on part:

Drill Deep Worksheet

Product XYZ Fuel Tank Rollover Valve Assembly

End cap not fully seated into window on valve.

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

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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.

M4Manufacturing was not aware of a new family insert.

M5Poor communication between Product Development & Manufacturing on design change.

M-RCSupplier 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 work and

error proofing

PreventManufacturing process -standardized work and

error proofing

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.

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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.

M4Manufacturing was not aware of a new family insert.

M5Poor communication between Product Development & Manufacturing on design change.

M-RCSupplier 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 work and

error proofing

PreventManufacturing process -standardized work and

error proofing

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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.

M4Manufacturing was not aware of a new family insert.

M5Poor communication between Product Development & Manufacturing on design change.

M-RCSupplier 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 work and

error proofing

PreventManufacturing process -standardized work and

error proofing

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?

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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.

M4Manufacturing was not aware of a new family insert.

M5Poor communication between Product Development & Manufacturing on design change.

M-RCSupplier 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 work and

error proofing

PreventManufacturing process -standardized work and

error proofing

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?

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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.

M4Manufacturing was not aware of a new family insert.

M5Poor communication between Product Development & Manufacturing on design change.

M-RCSupplier 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 work and

error proofing

PreventManufacturing process -standardized work and

error proofing

Drill Deep Worksheet

Also, 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.

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5 Whys Corrective Action Owner Due Date

P1RPN number was not determined properly in PFMEA.

P2Occurrence and detection ratings were not determined properly.

P3

P4

P5

P-RCInadequate 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 -informational content in FMEAs and CPs

PredictPlanning process -informational 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. . .

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Q1No 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?

ProtectQuality process -detection& responsiveness

ProtectQuality process -detection& 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. . .

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Drill Deep Worksheet

K1Engineering 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

K3Insufficient error-proofing incorporated into valve assembly.

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

J. Smith 03/31/04

K4Inadequate 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.

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Drill Deep WorksheetD ate : 02 /24 /04

Issue title :

C us tom er conce rn :

D e fec t on pa rt:

5 W hys C orrec tive A c tion O w ner D ue D a te

P 1R P N num ber w as no t de te rm ined p rope rly in P F M E A .

P 2O ccu rrence and de tec tion ra tings w ere no t de te rm ined p rope rly.

P 3

P 4

P 5

P -R CInadequa te k now ledge o f F M E A m e thodo logy.

F M E A tra in ing p lan to be deve loped and m on th ly F M E A laye red aud it rev iew to be im p lem en ted .

J . S m ith 03 /15 /04

M 1 C ylinde r d id no t trave l to fu ll inse rtion .

M 2P os itive s tops w ere no t ad jus ted co rrec tly fo r the new , low pe rm ea tion fam ily inse rt.

M 3C on tro l P lan w as no t upda ted to ind ica te reca lib ra tion fo r new fam ily inse rt.

M 4M anu fac tu ring w as no t aw are o f a new fam ily inse rt.

M 5P oor com m un ica tion be tw een P roduc t D eve lopm en t & M anu fac tu ring on des ign change .

M -R CS upp lie r X Y Z Launch P lann ing S ys tem w as no t fo llow ed .

R e-tra in em p loyees and im p lem en t a laye red aud it o f p lann ing p rocess .

J . S m ith 03 /31 /04

Q 1N o de tec tion e rro r-p roo fing fo r "end cap fu lly sea ted ".

Q 2

Q 3

Q 4

Q 5

Q -R CF a lse sense o f secu rity in e rro r p roo fing p reven tion o f pos itive s tops in too ling .

R e-eva lua te p reven tion e rro r-p roo fing p rocess and im p lem en t de tec tion e rro r-p roo fing p rocess .

J . S m ith 03 /15 /04

K 1E ng inee ring change m anagem en t execu tion .

D eve lop regu la r change con tro l m ee tings w ith en tire team .

J . S m ith 03 /31 /04

K 2 P P A P / P T R execu tion .D eve lop S upp lie r C hange R eques t aud it p rocess .

J . S m ith 03 /31 /04

K 3Insu ffic ien t e rro r-p roo fing inco rpo ra ted in to va lve assem b ly.

R e -eva lua te p reven tion e rro r-p roo fing p rocess and im p lem en t de tec tion e rro r-p roo fing p rocess .

J . S m ith 03 /31 /04

K 4Inadequa te k now ledge o f F M E A m e thodo logy.

F M E A tra in ing p lan to be deve loped and m on th ly F M E A laye red aud it rev iew to be im p lem en ted .

J . S m ith 03 /15 /04

K 5

W hy d id the m anu fac tu ring p rocess no t p reven t the de fec t?

W hy d id the qua lity p rocess no t p ro tec t G M from the de fec t?

W ha t a re the k ey find ings based on th is qua lity issue and the above 5

W hy ana lys is?

D rill D eep W o rksh ee t

P roduc t X Y Z F ue l T ank R o llove r V a lve A ssem b ly

E nd cap no t fu lly sea ted in to w indow on va lve .

W hy d id the p lann ing p rocess no t p red ic t the de fec t?

Loose pa rts found in P roduc t X Y Z fue l tank s . P R R # 30011223-989898 .

Pred ictPlan n in g process -

in fo rm at ion al con ten t in FM EA s an d CPs

Pred ictPlan n in g process -

in fo rm at ion al con ten t in FM EA s an d CPs

Preven tM an u factu r in g process -stan dard ized w ork an d

erro r p roofi n g

Preven tM an u factu r in g process -stan dard ized w ork an d

erro r p roofi n g

Pro tectQ uality process -

detection & responsiveness

Pro tectQ uality process -

detection & responsiveness

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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

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Read Across Matrix (Drill Wide)

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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: Springfield

Duns: 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]

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O

X

R

N/A

Original Location

Another Location which contains the same process

Repeat Issues

Not Applicable

Completed & 3rd Party/GM verified

Completed & Supplier verified only

Not 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

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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 issued Record the Date the Drill Deep AnalysisWas completed

Record the DEFECT on the part

Read Across Work Instructions

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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 initiated as a result of this PRR

Identify the CorporateChampion responsible to ensure implementation of the corrective actions

Read Across Work Instructions

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Identify all supplier DUNS locations with similar products and processes

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

Use letter code withappropriate color to identify applicable locations and status

Read Across Work Instructions

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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 Only

Not Completed

Issue Corrective Actions Champion Due Date

Pla

nt

1

Pla

nt

2

Pla

nt

3

Pla

nt

4

Pla

nt

5

Key Findings

Predict

Prevent

Protect

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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

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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 Only

Not Completed

Issue Corrective Actions Champion Due Date

Pla

nt

1

Pla

nt

2

Pla

nt

5

Key Findings

Departmental Review, On-line workshop

Failure 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 Plant

Define the Corrective Actions for each Systemic Issue