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APQP

Prod u ct and Proc es s Val idat ion

Jan ("Yon") RooversPresident

JAN ROOVERS ASSOCIATES, INC.Charlotte, North Carolina USA

Presented by:

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INPUTS Packaging Standards Product/Process Quality

Sys tem Review

Process Flow Chart Floor Plan Layout Characteristics Matrix PFMEA Pre -Launch Contro l P lan Process Instructions Measurement System

Analys is P lan

Preliminary Process Capabi l i ty Stud y Plan

Packaging Specifications

Management Support

OUTPUTS Production Trial Run Measurement System Evaluation Preliminary Process

Capabi l i ty Study Production Part Approval Production Validation Testing Packaging Evaluation Production Control Plan Quality Planning Sign -Off

and Management Suppo r t

4.0 Product and Process

Validation

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Defin i t ion/Purpose :To val idate the effect iveness o f the m anufactur ing proc ess .

A ct ion It em s:

Condu c t the p roduc t ion t r i al run us ing a llp lanned resourc es and c yc le t ime

De termine min im um quant i ty fo r the t r i al run Use ou tpu t fo r :

- Preliminary process capability study

- Measurement systems evaluation- Final feasibility- Process review- Production validation testing- Production part approval- Packaging evaluation- First time capability- Quality planning sign-off

4.1 Production Trial Run

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Defini t ion/Purpose:To evaluate the s tabi l i ty of th e specif ied

m easurem ent devices and m ethod s us ed toch eck the charac te r is t ics ident i f ied o n the

co nt ro l p lan .

A ct ion Item s:- Evaluate the m easu rement s ys tem

- Refer t o the MSA Manu al

4.2 Measurement Systems

Evaluation

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Defini t ion/Purpose:To d eterm ine the readiness o f the proc ess

fo r p roduc t ion .

A ct ion Item s:- Inc lud e al l ch aracter is t ics ident i f ied in th e

co nt ro l p lan for the capabi l i ty s tudy- Refer to th e PPA P Manu al

- Refer t o th e SPC Manu al

4.3 Preliminary Process

Capability Study

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Defini t ion/Purpose:To v a lida te that p rod ucts m ade f rom

produ c t ion too l s and de fined p rocesses

m eet engineer ing requirem ents .

A ct ion Item s:- Con du ct PPAP

- Refer to th e PPA P Manu al

4.4 Production Part Approval

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Defini t ion/Purpose:Engineer ing tes t s tha t va l ida te that p rodu cts

made f rom produc t ion too l s and de f ined

pro cess es meet eng ineer ing requirem ents .

A ct ion Item s:- Cond uc t required engineer ing tes ts .

- Refer t o ISO/TS 16949:2002

4.5 Production Validation Testing

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Defini t ion/Purpose:To assess the pro tec t ion of the prod uct f romnorm al t ranspor ta t ion d am age and adverseenviron m ental factors .

A ct ion Item s:- Condu ct tes t sh ipm ents- Select s pecif ied tes t m ethod s

NOTE:Custom er spec i f ied p ackaging does no tpreclud e the APQP Team 's invo lvement ineva luat ing th e packaging m ethod .

4.6 Packaging Evaluation

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Defini t ion/Purpose:To info rm Top Managem ent o f the prog ram s ta tus

and ga in the i r com m itment to ass i s t in (o r reso lve)any open issu es .

A ct ion Item s:- Ensu re that al l contro l p lans and pro cess

f low char t s a re being fo l lowed- Perform the review at the m anufactur in g

locat ion (s) and c oo rdin ate a form al s ign -off- Review the fol low ing i tem s:

(See next page)

4.8 Quality Planning Sign-off

and Management Support

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A ct ion Item s: Review the fo l lowing i t em s:

- Control Plans: Existence and availability at all times for all affected operations- Process Instructions: Must contain Special Characteristics;

all PFMEA recommendations addressed;compare process instructions and process flow charts to the control plan

- Gage and Test Equipment: Verify GR&R for all specialgages, fixtures, and test equipment

Be ab le to sh ow tha t al l requi rementsa re me t and c once rns do cum en ted

Schedule a management rev iew Refer to , and u t i l ize Ap pend ix F (Pages 93-94)

4.8 Quality Planning Sign-off

and Management Support (Cont'd)

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