Download pdf - APQP- In Progress

7/31/2019 APQP- In Progress

1/19

APQPTELEFLEX MEDICAL

PROGRAMME FOR SUPPLIERS2012


2/19

AdvancedProduct

QualityPlanning


3/19

Why

APQP? Ensures we know and meet CUSTOMER

EXPECTATIONS

We have the means and facilities to

produce

And deliver on time

And

Make a profit!


4/19

How do we know what the CUSTOMER

expects?

Customer Expectations

Well.they tell us.


5/19


Quality Products

Purchase Orders

Raw Material

Specifications Drawings

Purchase

Agreements Continuous

Improvements

Good Cost


6/19


Part Drawings and Specifications


7/19

How do we do it?

It starts with the Customer

Planning

Product Design and Development (Design FMEA)

Process Design and Validation (PFMEA and PPAP)

Then.the Supplier (Thats US)

Production

Program Approval

Timeline

LaunchPilotPrototyping


8/19

APQP Tools

Design FMEA (Failure Mode and Effects

Analysis):Customer Responsibility

Process FMEA:Supplier Responsibility Process Flow Path: Supplier Responsibility

Control Plans: Supplier Responsibility

W ll b i fl

di h f


9/19

POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS

(PROCESS FMEA) Part Number :

Customer Part Number:Date (orig): 10/8/2010 Part Name:

Date (rev): Prepared by:

Process C Potential O D Action Results

Function Potential Potential S l Cause(s)/ c Current e R. Recommended Responsibility

___________ Failure Effect(s) of e a Mechanism(s) c Process t P. Action(s) & Target Action S O D R.

Requirement Mode Failure v s of Failure u Controls e N. Completion Taken e c e P.

s r c Date v c t N.

10, 11,

12, 13

Raw Material

Receipt

Wrong

Marterial

Unstable

Process

8 Supplier shipped

wrong material

1 Supplier

Certification

7 56 Property

test each lot

of material

QA 1/1/95 Rejected -

-lab cost

prohibitive

Discoloration

of Product

Visual Inspection

Product

Mechanical

Failure

Visual inspection

20, 21 Injection

Molding

Mold Set Up

Error

Wrong Part

made

10 Wrong Insert

Installed

1 Visual Inspection 1 10

Wrong PartIdentification

Wrong Insert

InstalledIdentification

Visual Inspection

Process

Instability

Cooling Lines not

hooked up

Visual Inspection

Part inspection

22 Wrong

material

Incorrect

Mechanical

Properties

8 Wrong material

loaded in hopper

3 Work instruct ion with

lot # material usage

log

2 48 None

Cosmetic

Defects

Visual inspection

(Tool Room or

Mold Setter)

Suresh

Well briefly discuss three of

the Tools


10/19

Failure Mode and EffectsAnalysis

Used to evaluate RISK

Should address any Key Product Characteristicscalled out on the Drawing


(PROCESS FMEA) Part Number:Customer Part Number:

Date (or ig): 10/8/2010 Part Name:






s r c Date v c t N.

10, 11,

12, 13

Raw Material

Receipt

Wrong

Marterial

Unstable

Process

8 Supplier shipped

wrong material

1 Supplier

Certification

7 56 Property

test each lot

of material


-lab cost

prohibitive

Discoloration

of Product

Visual Inspection

Product

Mechanical

Failure

Visual inspection

20, 21 Injection

Molding

Mold Set Up

Error

Wrong Part

made

10 Wrong Insert

Installed


Wrong Part

Identification

Wrong Insert

Installed

Identification

Visual Inspection

Process

Instability

Cooling Lines not

hooked up

Visual Inspection

Part inspection

22 Wrong

material

Incorrect

Mechanical

Properties

8 Wrong material

loaded in hopper

3 Work instruction wi th


log

2 48 None

Cosmetic

Defects

Visual inspection

(Tool Room or

Mold Setter)

Suresh


11/19


(PROCESS FMEA) Part Number :Customer Part Number:

Date (orig): 10/8/2010 Part Name:






s r c Date v c t N.

10, 11,

12, 13

Raw Material

Receipt

Wrong

Marterial

Unstable

Process

8 Supplier shipped

wrong material

1 Supplier

Certification

7 56 Property

test each lotof material


-lab costprohibitive

Discoloration

of Product

Visual Inspection

Product

Mechanical

Failure

Visual inspection

20, 21 Injection

Molding

Mold Set Up

Error

Wrong Part

made

10 Wrong Insert

Installed


Wrong PartIdentification

Wrong Insert

InstalledIdentification

Visual Inspection

Process

Instability

Cooling Lines not

hooked up

Visual Inspection

Part inspection

22 Wrong

material

Incorrect

Mechanical

Properties

8 Wrong material

loaded in hopper

3 Work instruction with


log

2 48 None

Cosmetic

Defects

Visual inspection

(Tool Room or

Mold Setter)

Suresh

Closer Look at an FMEA

Severity: How great an effect on

the Ultimate Customer

A 1 to 10 scale

(10 being the worst effect)

Occurrence: How frequently can

this defect appear?

A 1 to 10 scale

(10 being the worst effect)

Detection: How confident our we

that our systems will capture this

defect?

A 1 to 10 scale

(10 being the LEAST Confident)

R.P.N.: Risk Priority Number?

Severity x Occurrence x Detection

The higher the number, the greater

the risk

We determine the Severity, Occurrence

and Detection levels (numbers) by a

Cross Functional Team usingexperience and past precedence.

We prioritize our Quality Checks orPoke-Yoke the Process by the RPN


12/19

Flow Paths

A Graphical Representation of a Process


13/19

Control Plans

A Document that describes the process in more

detail

Specific process setup instructions and inspection

requirements will be noted on the Control Plan At Teleflex Medical, the Control Plan is the parent

of documents

All Dimensions/Criteria noted on the FMEA mustbe addressed on the Control Plan


14/19

Control Plans

Lists Visual / Dimensions

to check

How to check themCheck Fixtures should

be listed here)How large a sample and

frequency of checks

along with what

documents to use

The Control

Plan explains

what to do if

you find

defectiveproduct


15/19

Now, put them together

The steps or dimensions on the FMEA,

Flow Path and Control Plan are to be

itemized with the numbering systemcorresponding on all three documents


16/19

The documents described

Are all tools to ensure we make a product that

meets Customer Expectations

Make up part of the PPAP (Production PartApproval Process)

Completion of the PPAP requires a dimensional

layout and a Warrant at the minimum

And, any other documents required by the

Customer


17/19

APQP

Helps prevent us from making mistakes by asystematic evaluation of a process

The tools described are an aid to this

The tools described are required by the Customer

for PPAP submission approval The overview of APQP and these tools are just an

introduction.

There are other, more sophisticated tools also

used. They are beyond the scope of thisintroductory presentation


18/19

For those of you still awake

This ends the Presentation


19/19

Q&A SESSION