Intensive Supplier APQP Training Course

2008. 10. 01

Mando Corp.

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Contents

. Background of Intensive Supplier APQP Training . DFMEA / PFMEA . Measurement System Analysis . Statistical Process Control . Control Plan . Early Production Containment

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. Background of Intensive Supplier APQP Training

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. DFMEA / PFMEA

FMEA1

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1. Definition of FMEA (Failure Mode and Effects Analysis)

A failure modes and effects analysis (FMEA) is a procedure for analysis of potential failure modes within a system for classification by severity or determination of the effect of failures on the system.

2. Purpose of FMEA
The purpose is to analyze, evaluate and resolve failure modes so that it prevents and minimize quality cost at customer site.
Reduce / remove failure modes

Quality
What are failure modes during production? What are failure modes during design?

PFMEA Production

Customer Defect

DFMEA Design

Production Failure Customer Requirement Design Failure

What are failure modes at customer?

FMEA Proper Timing, Timing of opportunity ( Countermeasure No!, Prevent Yes! )

FMEA2

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3. FMEA Negligence of Possible Failure mode

Common Knowledge of Failure mode Personally or privately Known Failure mode Actually occurred Failure Mode

Existing FMEA Existing Failure mode A a

Known Area

Personal and private Know How

New Failure mode

(A) (B) (C) a,b

Unknown Area
C

Highly Technical Forecast

: Neglected even though it actually occurred. : Neglected even though it could be predicted : Could not be predicted with retained knowledge. : Was predicted, but could not prevent

FMEA3

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4. FMEA Procedure
Supplier : Mando
FMEA NO Model Production Date Part # Part Name MDDF-A-002 A 04.05.01 XX000-000-00 Pipe&Bkt Assy Potential Failure Mode Potential Effect of Failure Class MDT Team Designer Completion Plan Kildong Hong 03.10.18 A B C Potential Cause of the failure
Current Process Control / Prevention Preven tion Detecti on

Page :
Rev initial A Date 03.10.20 Revised content Initial Release Prepared Checked -

Approved

03.12.04 RPN recalculated

Action Result Action Taken S E V

O c c u r

Target date

Function

R P N

Detect

Occur

SEV

Recommende d Action

D E T

R P N

What are the functions, features or requirement s?

Effects?

How severe is it?

What can go wrong? No function Partial / Over Function / Degraded Over Time Intermittent Function Unintended Function

What are the causes?

How often does it happen? How can this be prevented and detected?

What can be done? Design changes Process changes Special controls Changes to standards, procedures or guides

How good is this method at detecting it?

FMEA4

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5. FMEA Implementation
5.1 FMEA Responsibility
Item DFMEA PFMEA
1. New process for developing product 2. Process change due to E.O. 3. New process due to new conditions or new location. 4. F/Claim, customer quality issue Process engineer + Other related parties Potential failure due to process

Remark
*Involvement of related parties. (Team effort) *Evaluate all related system, SUB System, components and assembly. *Information to countermeasure legal action (Product Warranty)

Issue

1. Developing products 2. E.O. products 3. New condition or new location 4. F/Claim, customer quality issue

Responsibility Implementation

Design engineer + Other related parties Potential failure due to design

5.2 FMEA Analysis

Item Begin Complete DFMEA
Before or around Design Concept is finalized Initial release of drawing or before

PFMEA
During Feasibility evaluation or after initial drawing release Before 4M preparation (Final version : Before production)

Remark
*FMEA needs to be updated continuously for any changes (Living documents!)

FMEA5(1)

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5.3 FMEA Things to consider

DFMEA
1. Manufacture and assemble according to designers intention. 2. Potential failure modes during manufacturing, assembly or in mechanism will be included in PFMEA 3. Do not depend on control plan to overcome Design potential failures. 4. Consider technical and physical limits in manufacturing and assembly process.

PFMEA
1. Fully satisfy designers intention in products.
2. PFMEA may include design weakness and defects, but effect and removal should be included in DFMEA. 3. Do not depend on design change to overcome process failures. 4. Consider design characteristics related to manufacturing and assembly. 5. Support developing new machine and equipment.

5.4 FMEA Information to prepare

DFMEA
Drawing and specification List of KPC / KCC items B.O.M and function analysis chart Lessons learned and DFMEA from similar product.

PFMEA
Drawing, specification and DFMEA List of KPC / KCC items Process flow diagram, layout and machine manual Lessons learned and PFMEA from similar product.

FMEA5(2)

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6. DFMEA Process
Process
Organize a team and preparation Evaluate functions of System & Component Create a boundary diagram Predict failure mode Predict effect of failure and find a cause Current design control and technique Severity (S) Occurrence (O) Detection (D)

Content
The responsible engineer is expected to directly and actively involve representatives from all affected areas. Make a list of requirements for vehicle, system, assembly and components. A graphical illustration of the relationships between the subsystems, assemblies, subassemblies. And components within the object as well as interfaces. List failure modes that dont satisfy designers intention : Consider special conditions (ex. Crack, variation, leak) Effect due to failure : effect to customer, recognition by customer, predictable condition Cause analysis : Weak points of design (ex wrong material, improper design) Proper design to avoid failure modes and cause / recommended actions to avoid failure modes. Severity : Effect of failure to customer 1 (Low) ~ 10 (High) Predict technic Occurrence : likelihood of failure 1 (Low) ~ 10 (High) Predict technic detection : Possibility of detection with current setting 1 (Low) ~ 10 (High) Predict technique Risk Priority Number (1~1000) RPN = S (Severity) * O (Occurrence) * D (Detection) Order of action : Customer recommended item High Sev Occu Det Improve items that have RPN above 100 or S, O, D above 8 Recalculate RPN after improvement and compare product and quality information.

Rating

RPN(Risk Priority Number) Not satisf ied Recommended Action / Improvement F/Up RPN recalculate / Field Claim Compare

FMEA6

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7. DFMEA
1
Function

2
Potential Failure

3
Effect of failure

S E V

C l a s s

4Potential
causes of fauilure

O C C U R

Current Control Prev entio n Hardn ess check Detec tion PV Testin g

Pipe&Bkt Assy XX000-00-00 Bkt welded on Pipe and assembled with hose

Bad weld

Oil leak due to bad weld. Causes interference with hose and tire and leak will reduce brake performance

1 0
9

D e t e c t

9
R P N

6
Recommende d Action

Result

Action Taken

S E V

O C C U R

D e t e c t

9
R P N

Comp. Date

Improper welding method for thickness of material T = 2.6

3 7 1 5

*Process review : Co2 welding implemented (Projection--> Co2 welding)

12/ *Change process to Projection+Co2 3 (E.O.NO 00AB000) 9 1 7

(thickness variation occur only with Co2 )

6 3

6. Recommended Actions : Assessment for prevention/corrective action to reduce RPN

1. Function : Enter the name and other pertinent information of item being analyzed. Enter as concisely as possible, the function of the item being analyzed to meet the design intent 7. Completion date : completion date for recommended action 2. Potential failure : Potentially fail to meet or deliver the intended function (Crack, leak, etc) List each potential failure associated with particular item and function. 8. Action taken : Actual activity to reduce RPN after reviewing recommended actions. 9. RPN : S (Severity) * O (Occurrence) * D (Detection) 10.Classification : Classify any special product characteristics. 4. Potential cause of failure : indication of a design weakness . (ex. Wrong material or design) 5. Current design control : List the prevention, design validation/verification, or other activities which are completed or committed to assure the design adequacy General improvement wont change severity. (Root cause analysis is needed) Sev, Occur, Detect can not be 0 Order of action : Customer recommended item High Sev Occu Det

3. Potential effect of failure : effects of failure on the function, as perceived by customer. (ex. Malfunction due to oil leak)

FMEA7

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[Reference] RPN Rating Table (DFMEA)

1. Severity
Effect
Hazardo us w/o warning Hazardo us w/ warning Very High High

2. Occurrence
Criteria : Severity of effect Probabili ty
Very high : Persistent failures

3. Detection
Criteria : Likelihood of detection by design control
Absolute Uncertaint y Very Remote Remote Design control will not and/or cannot detect a potential cause and subsequent failure mode. Very remote chance the design control will detect a potential cause and subsequent failure mode. Remote change the design control will detect a potential cause and subsequent failure mode. Very low chance the design control will detect a potential cause and subsequent failure mode.

Likely failure rate

1,000 vehicle / part : More than 100 : More than 50

Ran k

Affects safe vehicle operation and/or involves noncompliance with government regulation without warning. Affects safe vehicle operation and/or involves noncompliance with government regulation with warning. Vehicle/item inoperable (Loss of primary function) Vehicle/item operable but at a reduced level of performance. Customer very dissatisfied. Vehicle/item operable but comfort/convenience item inoperable. Customer very dissatisfied. Vehicle/item operable but comfort/convenience item operable at a reduced level of performance. Customer somewhat dissatisfied. Fit and finish/squeak and rattle item does not conform. Defect noticed by most customers (greater than 75%) Fit and finish/squeak and rattle item does not conform. Defect noticed by 50 percent of customers. Fit & Finish / Squeak & Rattle item does not conform. Defect noticed by discriminating customers (less than 25 percent) No discernible effect

10 9 8 7

High : Frequent failures

: More than 20

: More than 10

Very Low

Moderat e
Low Very Low Minor Very Minor None

: More than 5 Moderate : Occasional failures

Low

Low chance the design control will detect a potential cause and subsequent failure mode.
Low chance the design control will detect a potential cause and subsequent failure mode. Moderately high chance the design control will detect a potential cause and subsequent failure mode. High chance the design control will detect a potential cause and subsequent failure mode. Very high chance the design control will detect a potential cause and subsequent failure mode. Design control will almost certainly detect a potential cause and subsequent failure mode.

6
5 4 3 2 1

: More than 2

Moderate Moderately High High

: More than 1

Low : Relatively few failures Remote : failure is unlikely

: More than 0.5

: More than 0.1

Very High Almost Certain

: Less than 0.01

FMEA)RPN

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8. PFMEA Procedure
Process
Obtain a process flow diagram Manufacturing process and boundary diagram Review risk in process flow Failure mode input Identify effect of failure and cause Current process control method Severity (S) Occurrence (O) Detection (D)

Contents
Review a process flow diagram and control items (function of process and improvement list) Minimum analysis level : One machine, multiple process machine and operation method Create a boundary diagram for critical process/machine according to PFD Risk review (moving operation, include transferring from process to process) Identify failure modes based on Lessons learned from previous quality issue Effects : machine, next user, environment, operator mistake, etc Cause : Process weakness (ex, wrong operation method, improper condition) Descriptions of the controls that either prevent to the extent possible the failure mode/cause from occurring or detect the failure mode or cause should it occur. Severity : Effect of failure to customer 1 (Low) ~ 10 (High) Predict technic Occurrence : likelihood of failure 1 (Low) ~ 10 (High) Predict technic detection : Possibility of detection with current setting 1 (Low) ~ 10 (High) Predict technique Risk Priority Number (1~1000) RPN = S (Severity) * O (Occurrence) * D (Detection) Order of action : Customer recommended item High Sev Occu Det Improve items that have RPN above 100 or S, O, D above 8 Recalculate RPN after improvement and compare product and quality information.

Rating

RPN(Risk Priority Number) Not Satis fied Recommended Action / Improvement F/Up RPN recalculate / Field Claim Compare

FMEA8

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9. PFMEA Input
1
Process Function

2
Potential Failure mode

3Potential
effect of failure

S E V

C l a s s

4Potential
cause of failure

O c c u r -

Current Control Prev ent Detec t 100% Visual Inspec tion

D e t e c t

9
R P N

6
Recommende d Action

7
Complet Date

Result

9
S E V O C C D e t R P N

Actions Taken

Pipe&Bkt Assy XX000-00-00 Bkt welded on Pipe and assembled with hose

BKT Welding Missing

Customer complaint due to missed welding on brake hose

1 inserted during 0 welding 8

Bkt was not

*Review Inspection

1 8 2 100% 8 inspection by
f/proof

12/ *As a result of review, laser sensor installed 3 at the tip of weld
(program installed to check for bracket before welding starts)

8 2 2

3 2

1. Process function : a simple description of the process or operation being analyzed. 2. Potential failure mode : the manner in which the process could potentially fail to meet the process requirements and/or design intent as described in the process function column (Crack, oil leak, customer complaint or operator input) 3. Potential effects of failure : The effects of failure mode on the customer (ex, customer complaint due to oil leak) 4. Potential cause of failure : how the failure could occur, described in terms of something that can be corrected or can be controlled. (ex, improper welding) 5. Process control : description of the controls that either prevent to the extent possible the failure mode/cause from occurring or detect the failure mode or cause should it occur
FMEA9(1)

6. Recommended Actions : Assessment for prevention/corrective action to reduce RPN 7. Completion date : completion date for recommended action

8. Action taken : Actual activity to reduce RPN after reviewing recommended actions.
9. RPN : S (Severity) * O (Occurrence) * D (Detection) 10.Classification : Classify any special product characteristics. General improvement wont change severity. (Root cause analysis is needed) Sev, Occur, Detect can not be 0 Order of action : Customer recommended item High Sev Occu Det

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Supplier : Mando

Process FMEA Potential Failure mode and effect analysis (A)

Designer Comp Date MDT Kildong Hong 03.10.18 A B C Rev 0 1 Date 03.10.20 03.12.04

Page :

FMEA NO MDDF-A-002 Vehicle A Production Date 04.05.01 Part # XX000-000-00 Part Name Pipe&Bkt Assy

Content Prepare (Sign&Date) Check (Sign&Date) Approved (Sign&Date) Initial Release Signed Signed Signed RPN recalculate Signed Signed Signed

Supplier : Mando

Process FMEA - Potential Failure mode and effect analysis (C)

Date 03.10.20
03.12.04

Page :
Remark
Quality

Rev 0
1

Content) Initial Release

4MDT Approval 5
Engineering

MDT R&D

Complete

sign
sign

sign
sign

sign
sign

Install E/Proof due to Quality Issue ( NCR xxx0000 ) and recalculate RPN Complete

Record Method 1~2. Rev and Date : Same as (A) 3. Content : Record change reason and description (Quality issue and NCR #, E.O. description and E.O. # ) 4. Always review the previous page for MDT approval. 5. MDT Approval : Obtain approval from related parties at PFMEA release

FMEA9(2)

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[Reference] RPN Rating Table (PFMEA)

1. Severity
Effect Criteria : Severity of Effect This ranking results when a potential failure mode results in a final customer and/or a manufacturing/assembly plant defect. The final customer should always be considered first. If both occur, use the higher or the two severities. (Customer Effect) (Manufacturing/Assmbly Effect) Rank ing

Class

Hazardous Affects safe vehicle operation and/or involves noncompliance with government regulation w/o w/o warning warning Affect safe vehicle operation and/or involves Hazardous noncompliance with government regulation with w warning warning Very High Vehicle/item inoperable (loss of primary function). Vehicle/item operable but at a reduced level of performance. Customer very dissatisfied. Vehicle/item operable but comfort/convenience items inoperable. Customer dissatisfied.

Safety Or may endanger operator (machine or assembly) without Characteristic ,Regul warning ated Characteristic Or may endanger operator (machine or assembly) with warning Or 100% of product may have to be scrapped, or vehicle/item repaired in repair dept with a repair time greater than on hour Or product may have to be sorted and a portion (less than 100%) scrapped, or vehicle/item repaired in repair dept. with a repair time between half an hour and an hour. Or a portion (less than 100%) of the product may have to be scrapped with no sorting, or vehicle/item repaired in repair dept. with a repair time less than half an hour. Or 100% of product may have to be reworked, or vehicle/item repaired off line but does not go to repair dept. Safety Characteristic Safety Characteristic(100% Scrap) Scrap Safety replaced Characteristic(scrap p after sorted) Repairable. Function defect, defect part (surface finish, related item) Function defect, assembly related

10

High

Moderate

Vehicle/item operable but comfort/convenience items operable at a reduced level of performance. Customer somewhat dissatisfied. Fit and finish/squeak and rattle item does not Very Low conform. Defect noticed by most customers (greater than 75%) Fit and finish/squeak and rattle item does not conform. Defect noticed by 50 percent of Minor customers. Fit and finish/squeak and rattle item does not Very Minor conform. Defect noticed by discriminating customers (less than 25 percent) Low None No discernible effect.

Or the product may have to be sorted, with no scrap, and Degradation Quality a portion (less than 100%) reworked. List Or a protion (less than 100%) of the product may have to be reworked, with no scrap, online but out of station. Dimension quality list

Or portion (less than 100%) of the product may have to be reworked, with no scrap, online but in station.
Or slight inconvenience to operation or operator, or no effect.

Appearance quality list

2 1

FMEA)RPN(1)

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2. Occurrence
Probabili ty
Very High : Persistent Failures

3. Detection
Ppk
0.55 Almos t Impos sible Very Remo te Remo te Very Low

Likely failure rate

Greater or equal to 100 per thousand pieces

Criteria
Absolute certainty of nonDetection

Inspection Type A B C
X

Suggested Range of Detection Methods

Cannot detect or is not checked

Rank ing 10

50 per thousand pieces

0.55

Controls will probably not detect

Controls is achieved with indirect or random checks only

Control is achieved with double visual inspection only Control is achieved with visual inspection only Control is achieved with charting methods, such as SPC Control is based on variable gaging after parts have left the station, OR Go/No Go gaging performed on 100% of the parts after parts have left the station. Error detection in subsequent operations, Or gaging performed on setup and first-piece check (for set up causes only) Error detection in station, or error detection in subsequent operations by multiple layers of acceptance: supply, select, install, verify. Cannot accept discrepant part. Error detection in station (automatic gaging with automatic stop feature). Cannot pass discrepant part. Discrepant parts cannot be made because item has been error proofed by process/product design. B : Gaging C : Manual Inspection

9
8 7

High : Frequent failures

20 per thousand pieces

0.78

X Controls have poor chance of detection X

10 per thousand pieces

0.86

5 per thousand pieces

Moderate : Occasional failures

0.94

Low
Control may detect Mode rate Mode rately High High Very High Almos t Certa in Controls almost certain to detect Controls certain to detect X Controls have a good chance to detect X

6
5 4 3 2 1

2 per thousand pieces

1.00

1 per thousand pieces

1.10

Low : Relatively few failures

Remote: failure is unlikely

0.5 per thousand pieces

1.20

0.1 per thousand pieces Less than or equal to 0.01 per thousand pieces

1.30

1.67

A : Error Proofed

FMEA)RPN(2)

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[Reference] PFMEA Working Model

EX 1 : Prevent failure due to physical design
Process: install a cassette eject switch on Control arm
Before: Switch has up & down direction. It can be installed upside down. After: The issue was eliminated by drilling different size holes to prevent installing the switch upside down.

EX 2 : Prevent failure due to machine

Process: Part is placed on a plate to be welded.
Before: A part can be placed on a plate in a wrong direction and welded. After: A block is installed to prevent a part to be placed in wrong orientation and the issue is eliminated.

Correct Orientation Part

Weld It can be installed upside down Hole (1) and (2) have different size to prevent Installing it upside down

Plate Block to prevent wrong orientation

Wrong Orientation

A part can be welded in wrong orientation

FMEA)F_(1)

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EX 3 : Detect before a part leaves a process

Process: Dril holes in series on a plate
Before: Depth of hole was solely dependent on operators. As a After: Two limit switches are installed. If drill passes beyond switches,

EX 4 : Detect after a part leaves a process

Process: Line down due to machine issue or trouble.
Before: When the line restarts after down time, parts sometimes come out After: Install a limit switch to check for height of parts to detect whether

result, holes sometimes werent

drilled to the correct depth and it caused trouble during assembly.

buzzer sets off to warn operators.

not machined. Not machined

parts sometimes go down to the next process and damage tooling.

parts are machined or not. When

it detects not machined parts, warning light comes on to notify operators.

Buzzer (Warning) Part

Limit Switch 1 Limit Switch 2

Limit Switch Warning Light

Not Machined Machined

Limit Switch Machined part

Switch one checks for start of process Switch two checks for depth

FMEA)F_(2)

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10. RPN Reduction Plan

APQP for each part should include RPN reduction plan through PFMEA process.

[ Guide #1 ] 1. RPN 100 : Improve related items

2. RPN 80 : Sev or Det or Occr 8 Improve related items

[Reference] GM : RPN 40 : Improve related items HMC : RPN 100 : Imprve related items.

[ Guide #2 ] Review RPN reduction plan using Form S19 : Improve top 5~10 items of overall process based on RPN Things to consider during RPN reduction improvement (S) Severity can reduced only through design change of part (O) Occurrence can be improved through process improvement, reduced variation, error proof and continuous monitoring of process. (D) Detection can be improved through enforced statistical control, sampling, error proof and enforced detection system.
FMEA10

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FMEA Reference 1) DFMEA, PFMEA Boundary Diagram

Initial KPC BOM Boundary Diagram Quality Characteristic D FMEA Mod/Add/Delete

KPC

ADVP & R

Engineering Standards

Quality Characteristic

Process Flow

Process Analysis

PFMEA /
RPN reduction Plan

Control Plan

Work Standard

Mod/Add/Delete

Gage, Tool, Machine Spec

Initial KCC

KCC

FMEA)/FMEA

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FMEA Reference 2) Cause of Failure Mode

Design Quality Issue Machine, Hardness, Material, Dimension, Machining Method Environmental Condition High/Low Temp, humidity, salt water, wind, sulfurous acid, light, pressure

Manufacturing Quality Issue Machining, Assembly, Heat Treatment, Coating, Transportation

Maintenance Condition

Water, Oil

Application Condition

Oil, Magnetism, Pressure, Chemical, Vibration, Assembly Location

FMEA)

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FMEA Reference 3) Failure Mode Category

Item Category
Mechanical Failure

Remark
Deformity, damage, wear, defect, omission, clogged, humidity Short, Drift, R Fluctuation, High Resistance Corrosion, deterioration, oxidation, fusion, explosion Damage, wear, deformity, break, disconnection, cut Missing, sticking, contact, short, cross, caught Dimension, material, install, pressure

Failure Mode

Electrical, Magnetic Failure Chemical Failure

Failure Area

Failure on part
Failure between parts Initial failure mode

Failure Conditio n

Failure due to wear Abrupt Failure

Corrosion, discoloration, fusion, wear, contamination Damage, wear, deformity, break, disconnection, cut

FMEA)

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Purpose of P-FMEA is to last and to update for the life time of part. Its called living documents.
Once part is in production, any changes in design and process must be reflected

on PFMEA
If process is changed to improve design and process, PFMEA must be revised and evaluated for effects of severity, occurrence and detection. The below processes are generally not followed. Recognize that P-FMEA is living documents when review. Develop a process to systematically update FMEA for design and process change.

FMEA11

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. Measuring System Analysis

MSA1

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1. MSA (1)

Definition of Measurement System

* the collection of instruments or gages, standards, operations, methods, fixtures, software, personnel, environment and assumptions used to quantify a unit of measure or fix assessment to the feature characteristic being measured.

Measuring System
MSA2

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1. MSA(2)

The definition of MSA

* MSA : Measurement System Analysis * To improve process and its understanding with Analysis of characteristics affected to process variation (Inspector, gauge
D Martial: The variation of A material T Method: The variation of A method
Environment: The variation
Of environmen Person: The variation of person Gauge: The variation of guage

M S A

Z E R O Vari ation

Impro Vement Of relia bility

MSA3

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1. MSA

The timing of MSA activity

* When 1st trial run (PILOT event) * When adding special characteristics * When modification of characteristic of MSA * Regular analysis (1/ye)

Objection of analysis
* MSA from control plan. (Gauge, Person, Method, Environment)

MSA4

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1. MSA

The kinds of MSA and its range

* Quantatative MSA Linear, stability Repeatability, Reproducibility * Qualitative MSA Easy evaluation method

MSA5

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1. MSA

What is variation of MSA?

Total variation

Variation between components

Variation by incorrect measurement

In Group

B/W group

Inspector
Reproducibility)

Guage

Accuracy Variation b/w components Variation b/w inspector Total variation Reproducibility Stablity

+
MSA6

=
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Linearity

2. Requirement of MSA Accuracy

Repeatability

The variation between average of measurement The variation when measurement with one and true value by measurement infinitely. Samples infinitely.

Def.

The average of variation of measurement True value Accuray

True value

Repeatability

Cause

Outworn of gauge, non conformance gauge Mishandling or bad habit

Gauge clearance, Outworn of gauge, Function broken, Wrong process of measurement Variation of product, environment

MSA7

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2. Requirement of MSA (2) Stability

Variation with time passing

Time 2

Reproducibility

The variation of average of measurement when two person measure one gauge.

Operator 2 Reproducibility

Def.

Stability

Time 1

Operator 1

Cause

Outworn of gauge Variation of environment

Different gauge, different method and its environment , personal habit, no knowledge

MSA8

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3. Definition of Gauge R&R

Definition of Gauge R&R * GAGE Repeatability & Reproducibility

* The variation between gauge usage and its inspectors That can be used as judgment after analysis variation of measurement system.

MSA9

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4. Preparation of Gauge R&R

Variation cause Preparation Generally 2 or 3 operators perform, who use gauge Inspector need how to measure, regularly. Recommend mark specially on samples to decrease variation. All inspectors must know how to measure. (Need training before new gauge usage) Generally take 10 samples, numbering on samples. (Required over general if perform break load)

Man

Method

Material

Samples should be chosen near Between upper and lower spec.

Machine

Use gauge which has more smaller unit (1/10)than items inspected.
All gauge should be calibrated. Measure where there is no variation of environment. (Temp. 21 , humidity 50%, good vantilation)

Environment

* Right inspectors, gauges should be used when MSA.

MSA10

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5. Measurement location and importance of method

Measurement location/importance of method ex> Variation due to positional tolerance and centrality

?
X

MSA11

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6. The standard of evaluation for Guage R&R

Variation 10% 10 ~ 30% Fully Acceptable Acceptable o n condition of expense of repair, its importance(Action plan may required.) Need improvement ( Required action plans) After corrective actions, evaluation of MSA required to perform again. Standard

30%

Repeatability (Variation of gauge)

Reproducibility Variation of operator

Total Variation

MSA12

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. (SPC)

SPC1

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1. Outline of SPC (1)

The Definition of SPC

* Statistical Process Control * To use statistical method to meet process capability target.

The purpose of SPC

* To insure keeping confirming parts with improving process and to eliminate waste .

SPC2

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1. Outline of SPC (2)

The definition of process capability

* The ability of quality improvement under good control System, the variation of product under standardized process.

The value of process capability

* Cpk = The variation allowed of process/ Actual process variation = (SU-SL) / 6 * Cpk : Long term process capability including process variation * Ppk : Shorterm process capability without process variation

SPC3

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1. The outline of SPC(3)

The definition of control chart

* To use and display related process control condition with timeline, the control chart is used for keeping process stable

Monitoring of process according time change.

The verification of process improvement activity. The data to evaluate accurate process capability

SPC4

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[Ref] Example of control chart

SPC)

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1. Outline of SPC

6 = Cpk 2.00 implementation

Perfect product= Perfect process

Quality

Productivity

SPC
SPC control SPC analysis
understanding variation

Control

Minimize if variation

Perfection

Disregard of Contorl limit

SPC5

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2. The importance of SPC and Improvement

Control lower limit Control upper limit

The 10 samples are ok itself. During 0.1biliion production for 10yrs

our process includes some of non conforming parts according to graph, we can estimate.

We can estimate 0,1 billion with 10 samples. 10 20 If 100, 300 it is better estimation with 10pcs. estimation with 100pcs,100

300pcs sampling result is more accurate than 100pcs sampling. We can future of process estimnate the . 300 We need to produce at least 300pcs for pilot building.

() ?
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SPC6

2. The importance of SPC and Improvement (2)

What is important to keep stable quality Is not sample qty but is-3 and

+3 is

within control limit.

-3

x Bar

+3

What should we do!!!

To decrease the variation of process To be middle with limit To have sufficient process capability To have stable quality performance
SPC7

-43-

3. The analysis of process capability and its evaluation.

1) The process capability and 6 sigma 2) The judgment of control chart Non
Control limit 1 2 3 4 5 (Cpk) 0.33 0.67 1.00 1.33 1.67 Conform ance rate (%) 68.27 95.45 99.73 99.9937
99.999943
99.9999998

conforman ce Rate (ppm) 371,300 45,000 2,700 63 0.57

SPC

The kinds of Control Charts Almost dots are near control limit(CL) Few dot is in UCL,LCL There is no dot out of control limit Continuous 25 dots are within control limit Continuous 34dots of 35 are within control limit. Continuous 98 dots of 100 are within control limit.

Good control

Very good control

2.00

0.002

3) The standard of process capability

Process development Sufficient Need impro condition ment nok Pp , Ppk 1.67 1.33 Pp , Ppk < 1.67 Serial production Cp , Cpk 1.33 1.00 Cp , Cpk < 1.33

Pp , Ppk < 1.33

Cp , Cpk < 1.00

SPC8

-44-

3. The analysis of process capability and its evaluation(2)

Process capability improvement system Clear purpose Special Selection of object 4M standardization Standard work activity Data selection/ analysis Process = Contorl condition Understanding Of process capability o Sufficient Insufficient ability ability Process Establish Control Target with *Confirmation Consideration Process Of ecomic. capability Process Control Understand Of special cause Action / Standardization Studying of Cause & machin capa No cause/No Action 4th grade Specification review/ Control 0.67 > Cp 3rd grade 1.00 > Cp 0.67 2nd grade 1.33 > Cp 1.00 1st grade 1.67 > Cp 1.33 * Sufficient of process capability Good condition Cp 1.67 Grade Cpk Evaluation/Action plan * Very sufficient of process capability Even though the variation is bigger, No worries. Easy control, cost reduction is required.

* Not bad of process capability Corrective action is required depend on concerns.

* Poor process capability Some non conforming parts. 100% sorting , strong control and continuous improvement are required, * Very poor process capability No satisfaction of quality, production stop urgent action plan are required.(All process should be reviewed)

SPC9

-45-

4. The Cause of poor Process capability and its corrective action)

Common Cause Common Cause Chronic Cause Unpredictable cause Usual Cause Usual Case Special Cause Accidental cause Predictable Cause Unusual Cause Unusual Case Not chronic and scattered casue * Operators mistake * The use of non conformance * The variation of Production equipment Special Cause

* A ineluctable cause under well controlled system * The variation of operation skill * The variation of operation environment * The small variation of unindentified

Responsibility & Improvement The responsibility of management)\ Improvement of system 75~80% is solved by care of management 25~20 is solved by floor operators The responsibility of operators SPC Floor operators reorganization

SPC10

-46-

5. The calculation of process capability

(Standard) m = X bar ( ) = Cp SL T m Su * : Cp = (T/6) (, T=Su-SL) T/2 = V = R bar / d2 SL m X bar ( ) = Cpk m X-bar Su * K =m-X bar / (T/2) * : Cpk = (1-K) Cp = (1-K) (T/6)

6
(One side only) Su (If only Su given) X-bar Su SL SL (If only Su given) X-bar

* Cpu = (Su-X bar) / 3

* CpL = (X bar-SL) / 3

3
SPC11

3 -47-

6. Control Chart Interpretation

(Definition) (Control) Run Trend Unusual patterns Only one way data on going to one control limit

A sequence data on the same char Only one way data on going -acteristic Attention of on going process Need preventive action Improvement Action Attention of on going process Need preventive action Improvement Action

Change of component or sub assy. Outworn machine Continuous 10 dot of 11 on one side X-bar Change of operator or machine Fatigue of Operator Continuous 12 dot of 14 on one side Control Change of equipment or method Change of environment Continuous 14 dot of 17 on one side chart Change of inspection tool or methodOutworn tooling Continuous 16 dot of 20 on one side (Cause) Change of materials R Change of materials Fatugue of operator Control Change of production process Change of components composition Chart Change of operator Change of receiving.

Run
X-bar R Control chart Trend Unusual pattern

SPC12

-48-

 (Process Quality Control)

SPC (MSA and SPC) ? Process capability
(If (Maintenance of Control plan) satisfy)

(Sofeware)
YES (Stable)

DATA ? Quality of Data?

? Control condition?

* * (If not satisfy) (System improvement)

(Control Chart)

MSA
* * (Unstable) (Improvement of MSA)

* NO * (Remarkrs (Removal of special cause) Cpk

Cpk does not meaning Under unstable process)

-49-

SPC13

. (Control Plan)

CP1

-50-

1. (Definition)
FMEA , , . A control plan is a documentation describing the critical to quality characteristics of a Part and process which is receiving, internal process and shipping.

The documentation to be informed system information to minimize the variation of process and parts

2. (Category of Control plan) :

(Prototype control plan: is used in the early development stage when the parts or process is being configured.)

Pre-Launch : MIP PPAP ( ) Pre-launch

: .
(A Production control plan: is used for the full production of a part)
-51CP2

control plan: is used after the prototype phase is complete, and before full production is approved)

3. (The importance of control plan)

() The road map to fullfill quality target. (The documentation of process control)
. (Do specify for each process. . (Do indentify special charateristics) - (KPC, Key Product Characteristics) - (KCC, Key Control Characteristics) . (Do specify measurement standard) - / (method/quantity) - (frequency) . (Do specify reaction plan)

(The controlled system to follow up according to procedures when problems occurs)

CP3

-52-

4. (Control plan Development flow)

Process flow chart) FMEA (PFMEA)
/ (Potential failure/predictive cause) Activity of minimize process failure) RPN NO RPN reduction plan.

Decision of root cause

(Production) (Quality Control, tech) (Management) NO

(Controlled method) (Controlled frequency) (controlled

Problem solving
YES

P-Control Plan

YES

? Process Controlled?

Equipment & Facilities

, Gauge, mold and tools

Work standard

/ Problems occurs Quality/Production

Measurement and documentation

Check sheet

CP4

-53-

5. (Application of Control plan)

(Prototype Control Plan) (Drawing /specification) (Team knowledge) / / FMEA System design/PFEMA / Product/Special Charateristic) (QFD, DOE, Matrix) / Lesson Learned.Quality history / Layout Process Flow diagram/Layout - (Definition) : , ,
, : Prototype making procedure, measure -ment, material handling controlled proce -dure.

(Pre-Launch Control Plan) - (definition)

: Pilot ( ) , , After prototype, while pilot or serial production produce, quality control documentation including of appearance Dimension and function of product - : Proto ~ Duration: proto to before SOp

(Production Control Plan)

- / - Implement items which have review Since prototype. - (Revision documentation of pre Control plan)

(Work Standard) (MSA) (Analysis of first procss capability)

- (Corrective actions)

(Increase of inspection frequency) / (Increase of inspection points) (SPC evaluation) (Increase of inpection)

* FMEA (Living Document) ( / ) 1. (When change product and process) 2. (When process is unstable) 3. (When process capability does not meet) 4. (When change Inspection standard and process control method.) -54-

- : Duration: during prototype

CP5

6. How to make control plan

( Control Plan )
PreLaunch SU MAIN B b / / No

a
Char Spec Frequen 6 cy 7

/()

/() Process Machine Product Process

No

Characteristic (Product): Fill out which items of product inspect (Appearance, function, dim)
Characteristic (Process): Fill out what operators keep the method

Special Characteristic: Specially mark for the item which identify by customer, design and FMEA Spec: Fill out the specification of drawing or other customer requirement. Characteristics of process control: Fill out control limit to meet specification. Please, fill out practical control limit instead of reference)

Project Team Sign All CFT members need to sign up (When 1st or revision control plan) From receiving inspection to ship, All specific process should be written

Evaluation: Fill out the method to measure the specification.

Frequency: Inspection, test, measurement frequency Method: Fill out how to control and how to keep the record. Responsibility : Fill our the responsibility

Reaction plan: According to non conforming process, clearly describe sort, rework and scrap.
CP6

-55-

7. Main problems of control plan MDT / CFT , Control plan is not done by MDT/CFT but a team or personal Not correlation between product characteristic and process variable ( ) Modification (especially process improvement) is not done. : FMEA , : need correlation of PFEMA, quality concerns and its corrective action. ( ) . Poor confirmation to check such as check list. . (Poor control system of modification)
: C (Please, use documentation C)

CP7

-56-

) Relation b/w Work standard and inspection standard

Work instruction

( ) Frequent inspection (1st/2nd/3rd) / (parameter of equipment control/maintenance regular check) (Error proof)

....

FMEA & Process Flow Diagram

Control plan

(Operator) Check Sheet (Regular inspection) (Error proof)

Inspection standard (/) In process/Receiving)

Drawing

(Inspector) Check Sheet

Layout Inspection

.... ....

/ Function/material spec.

() Inspection agreement

Layout inspection report

....

CP)

-57-

. (EPC) (Early Production Containment)

EPC1

-58-

1. EPC (The purpose of EPC)

.(Verification of control plan of serial production) PPAP . (Prevention of non conforming parts at car assembly line during bump up since SOP. Data . (Documentation of data to verify process control) Issue , , . (Early serial products containment for any quality concerns and its corrective action taken) ( ) . To increase managements intererst.
EPC2

-59-

2. EPC ? What is requirement of EPC?

EPC (Required separate location from production line) 100% (Required to verify for infortant characteristics to inspect) EPC , Tool ( ) : 3 . (Required to specific inspector and give them work standard) (Layered Audit Process) (Perform layered audit process) . (Need to trace all non conforming parts) According to customer requirement, EPC (
EPC3

It can be changed.

-60-

3. EPC (EPC Process Flow Diagram) EPC , . (After successful EPC, the serial production process should be used. . EPC
(Production)
Robust Control Plan

. EPC place should be considered as customer place.

(Ship)

(Final Inspection)

Information Board In EPC (Process) Scrap Out

/ Packaging/Label

EPC4

-61-

4. EPC (EPC Information Board)

Training manual

Layered Audit Performance

(Using check sheet

Work Process How to handle Non conformance

Inspection Standard

Organization

ETC

I-Chart
(Separate inspection Sheet

Status Non conforrmance

EPC5

-62-

5. EPC
EPC Locatioon
EPC Location EPC Status

EPC in out
In - YELLOW ZONE

EPC OK Sticker

Out - GREEN ZONE

GP-12 gauge location calibrated.

Non conforming parts

EPC6

-63-

6. EPC ? When does EPC perform? EPC (Misunderstanding of EPC at supplier) EPC SOP ?? EPC will perform only after SOP.

NO !
. Since prototype, the sample which supplies to customer should be inspected.

EPC7

-64-

7. EPC (EPC Activity standard)

EPC ? (When can we close EPC)

SQA EPC Data SQA .

(Supplier needs to submit data to Mando SQA and needs confirmation to close EPC by SQA of Mando.
EPC ? (EPC is not performed?
EPC (Poor implemenation) EPC (Non conforming may supply to the customer)
EPC8

(Controlled Shipping)

-65-

The End
Q& A

-66-

[] (Ref. Control Process and its concept)

Process control

(controlled) ( ) Remove causes

(unusual) ( ) Special cause

Process capability

Controlled and process capability ( ) Remove variation (controlled but no process capability) ( ) (Too large variation due to casues)

SPC)/

-67-

[] The definition of common and special casue

Common cause
Statistically Stable Good control Predicatively Statistically

Special Cause
Possible Prediction
Significant Change) Unstable Out of Control No Prediction

Not available Prediction

SPC)/

-68-