,

? ,? ,,, Prepared by: Casey Jen 7/26/2012

:

Villanova

:SPC, QFD, MSA, FMEA, 8D, QCC, ISO 9000/TS16949 :2000, ISO 14000,TL 9000, 6 Sigma, TRIZ (Theory of inventive problem solving), :,, :,,,, (Optimal/Total Design) Neville Clark ISO 9000 :

:

HTC , ()/ / A() / / CED ,,,,

ABCDEFG......HIJK.....

,ABCDEFG : A Boy Can Do Everything for Girl. , HIJK He is Just Kidding

, , , ,

,(Appearance) ,, , (Cosmetic),,,,,/ ,, ,

---

, ,,

, , , ,

,

,

,

,, , (Quality System Audit and Quality Process Audit) , ,,,

Q,C,D

:40%,30%,30%

(Material)(Resources) ,ERP (Enterprise Resource Planning)

QSA,

(HP, Dell, Apple, IBM, Sony ),(SQA, Supplier Quality Assessment) (GM, Chrysler, Ford)

TS16949 QSA(Quality System Assessment Manual) APQP, PPAP, FMEA, MSA, SPC,

Formel-Q, VDA-6

/

,,, ,

QSAQPA Checklist

(Sleeping vendor) (Audit Evidence),(Conformity Audit),,, ,,QSA QPA

ISO/TS16949 2002 PPAP

, (Robustness),, , , PPAP, 18 , PPAP,,

PPAP

2.1(Design Records)

2.2(Authorized Engineering Change documents) 2.3 (Customer Engineering Approval) 2.4(Design FMEA), 2.5 (Process Flow Diagram) 2.6 (Process FMEA)

PPAP

2.7 (Control Plan) 2.8 (Measurement System Analysis Studies)

,,,,

2.9 (Dimensional Results)

2.10 /(Records of Material/Performance Test Result)

,,

PPAP

2.11(Initial Process Studies) Cpk, Ppk;

X bar-R ,25, 100 1.67, 1.331.66

d2C4 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 C4 1.128 1.693 2.059 2.326 2.534 2.704 2.847 2.97 3.078 3.173 3.258 3.336 3.407 3.472 3.532 3.588 3.64 3.689 3.735 d2 0.7979 0.8862 0.9213 0.94 0.9515 0.9594 0.965 0.9693 0.9727 0.9754 0.9776 0.9794 0.981 0.9823 0.9835 0.9845 0.9854 0.9862 0.9869

=

,CPUCPL CPK

, =

, =

( )2 ,K 1

PPK

,Process Performance index) PPK=Min(PPU-PPL) PPKCPK,, (Total variation, Actual Sigma, root mean square) = ,X = 0,X = , ,PPK = ) Accuracy, Ca = ()2 , 1

,( |X| , /2

Cpk, Ppk?

,R ,,, , ,CP=T/6, CPK=(1-|Ca|) X CP Ca,,R , ,, ,,CPKPPK, ,

Ppk, Cpk

PPK>1.67 1.33 1.66,CPK>1.33 ,, , ,(), (R),, (SPC), ,

,

,

,,

: 1. (,) ,,100% 2. ,, 3. ,, 4. ,, ,,? , ??GR&R ?()

5. ,, , 6. ?, ? ?( , Gage R&R) ,,? , ?

7. (Master or limit sample), ,,? 8. , , ,

9. ,,, 10. ,, MSD(Moisture Sensitive Device ),ESD (Electrostatic Discharge Protection,

(Lean production) JIT(Just in Time)

, , MRP (Material requirement planning), ,

JIT 1. 2.

3.

() JIT, , , (, , , )

JIT 4. 5.

6.

, /,CAR, WIP,

JIT 7.

8. 9.

10.

(Engineering Change), (Close loop) (Spare Parts ratio)

, , GIGO:Garbage in, Garbage out) (Test coverage) , (QA Agreement),

,

,SPC FMEA, FTA QC7, 6sigma8D

(Audit Suggestion): (Audit finding):,

PDCA, 6 sigma8DPDCA,(Bottom up) 6 sigma(Top down), (Critical to quality, CTQ) 8D,

PDCA, 6 Sigma DMAIC 8 DPDCA Plan Deming 1. Define problem DMAIC Recognize Define What Why 8D 0.Prepare for Problem Solving 1. Team Assembled (OJT)

,, ; ? , , 5W2H (FMEA) , ,

2. Study Problem

2.Problem Description

3.Analyze Causes

How

3.Interim Containment Actions (/ , ,)

Do

Plan Changes 4..Implement solution Measure Analyze Improve Control

4. Diagnose Root Cause a. b. "", c. 5.Identify Solutions a. 5 Why Analysis, , / ; ; /FMEA // ; / 8.Congratulate Your Team ,

, QC

Check 5. Check Result

b. Action 6. Standardize Solution Standardize 6. Verification/Validation/ 7. Establish future Plan Integrate 7. Prevention (Design/Information Systems Review) (/)

Quality Management System Manual Manufacturing/Inspection WI Flow Charts; Control Plans Design/Process FMEA Gauges/Facilities/Jigs Engineering Change Approval; PPAP Manufacturing/Inspection Forms

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:

,,, ,, , , ,, , (Sellers market),

1: (http://www.wpto.com.tw), (USPTO, http://portal.uspto.gov/external/portal/home)( Japan Patent Office, http://www.jpo.go.jp)(http://www.epo.org/), (IPOhttp://www.tipo.gov.tw/) 2: PPAP ,FMEA, SPC, MSA, APQP,AIAG, ,http://www.aiag.org/scriptcontent/index.cfm 3: ISO/TS16949:2002,PPAP, Production Part Approval Process 2006, 4 4:IMDS /IMDS http://www.mdsystcm.com/index.jsp 5: n,http://www.qimacros.com/control-chart-formulas/cp-cpkformula/ 6: 8D,Process Improvement Group ,PIG,,, ,http://www.mostquality.com/Quality/pig.pdf 7: ,, http://www.au.af.mil/au/awc/awcgate/navy/bpi_manual/handbook.htm http://www.balancedscorecard.org/BSCResources/ArticlesWhitePapers/ProcessImpr ovementTools/tabid/243/Default.aspx

Memo (BOM, Bill of Material)

(Raw material) ,(,, ,),(,,, )(,,, ) ,, ,,,, ,

Rosh

1. 2. 3. 4. 5. 6.

PBB PBDE

X-Ray(X-Ray Fluorescence, XRF) (Al) (Mg)(Si) (Cl) (P) (S) ,

(Parts)

( ) ,,(,) ()(Subassembly), ,

(Semi-finished goods)

(Finished good)

(Packing Material)

,

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The End

Thanks Q&A