APQP

TELEFLEX MEDICAL PROGRAMME FOR SUPPLIERS 2012

Advanced Product Quality Planning

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!

Customer Expectations
How do we know what the CUSTOMER expects?

Well.they tell us.

Customer Expectations

Quality Products Purchase Orders Raw Material Specifications Drawings Purchase Agreements Continuous Improvements Good Cost

Customer Expectations

Part Drawings and Specifications

How do we do it?
It starts with the Customer
Planning Product Design and Development (Design FMEA)

Then.the Supplier (Thats US)

Process Design and Validation (PFMEA and PPAP) Production

Timeline Program Approval Prototyping Pilot

Launch

APQP Tools

Design FMEA (Failure Mode and Effects Analysis): Customer Responsibility Process FMEA: Supplier Responsibility Process Flow Path: Supplier Responsibility Control Plans: Supplier Responsibility

Well briefly discuss three of the Tools

POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (PROCESS FMEA)
Date (orig): Date (rev): Part Num ber: Custom er Part Num ber: Part Nam e: Prepared by: Suresh

10/8/2010

Process Function Potential Failure Mode Potential Effect(s) of Failure S e v

C l a s s

Potential Cause(s)/ Mechanism (s) of Failure

O c c u r Current Process Controls

D e t e c R. P. N. Recom m ended Action(s) Responsibility & Target Com pletion Date

Action Results Action Taken S e v O c c D e t R. P. N.

___________
Requirem ent

10, 11, 12, 13

Raw Material Receipt

Wrong Marterial

Unstable Process Discoloration of Product Product Mechanical Failure

Supplier shipped wrong material

Supplier Certification Visual Inspection Visual inspection

56

Property test each lot of material

QA 1/1/95

Rejected -lab cost prohibitive

20, 21

Injection Molding

Mold Set Up Error (Tool Room or Mold Setter)

Wrong Part made Wrong Part Identification Process Instability

10

Wrong Insert Installed Wrong Insert Installed Identification Cooling Lines not hooked up

Visual Inspection Visual Inspection

10

Visual Inspection

Part inspection

22

Wrong material

Incorrect Mechanical Properties Cosmetic Defects

Wrong material loaded in hopper

Work instruction with lot # material usage log Visual inspection

48

None

Failure Mode and Effects Analysis

POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (PROCESS FMEA)
Date (orig):

Process

Function

___________
Requirem ent

Used to evaluate RISK Should address any Key Product Characteristics called out on the Drawing
Part Num ber: Custom er Part Num ber:

10/8/2010

Part Nam e:

Date (rev):

Prepared by: Suresh

C l a

Potential

O c c r

D e t e c

Action Results Action S e v O c c D e t R. P. N.

Potential Failure Mode

Potential Failure

S e v

Cause(s)/ of Failure

Current

R. N.

Recom m ended Action(s)

Responsibility & Target Date Com pletion

Effect(s) of

Mechanism (s)

Process

P.

s s

Controls

Taken

10, 11, 12, 13

Raw Material Receipt

Wrong Marterial

Unstable Process Discoloration of Product Product Mechanical Failure

Supplier shipped wrong material

Supplier Certification Visual Inspection Visual inspection

56

Property test each lot of material

QA 1/1/95

Rejected -lab cost prohibitive

20, 21

Injection Molding

Mold Set Up Error (Tool Room or Mold Setter)

Wrong Part made Wrong Part Identification Process Instability

10

Wrong Insert Installed Wrong Insert Installed Identification Cooling Lines not hooked up

Visual Inspection Visual Inspection

10

Visual Inspection

Part inspection

22

Wrong material

Incorrect Mechanical Properties Cosmetic Defects

Wrong material loaded in hopper

Work instruction with lot # material usage log Visual inspection

48

None

Closer Look at an FMEA

POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (PROCESS FMEA)
Date (orig): Part Num ber: Custom er Part Num ber: Part Nam e:

___________
Requirem ent

10, 11, 12, 13

Raw Material Receipt

20, 21

22

We determine the Severity, Occurrence and Detection levels (numbers) by a Cross Functional Team using Detection:HowPriority Number? Occurrence: How frequently can Severity:Risk past precedence. R.P.N.: Howgreat an effect we confident our on experience and that ourthis defect appear? this thesystems will capture Ultimate Customer Severity x Occurrence xChecks or Detection We prioritize our Quality defect? A 1 to 10 scale the RPN Poke-Yoke the Process by greater The higher the number, the A 1 to 10 scale (10 being the risk effect) the worst
Date (rev): Prepared by: Suresh Process C l a Potential O c c r D e t e Action Results Action Function Potential Failure Mode Potential Failure S e v Cause(s)/ of Failure Current R. N. Recom m ended Action(s) Responsibility & Target Date Com pletion Effect(s) of Mechanism (s) Process P. S e v O c c s s u Controls Taken c

10/8/2010

D e t

R. P. N.

Wrong Marterial

Unstable Process

Supplier shipped wrong material

Supplier Certification

56

Property test each lot of material

QA 1/1/95

Rejected -lab cost prohibitive

Discoloration of Product Product Mechanical Failure

Visual Inspection Visual inspection

Injection Molding

Mold Set Up Error (Tool Room or Mold Setter)

Wrong Part made

10

Wrong Part Identification Process Instability

Wrong Insert Installed Wrong Insert Installed Identification Cooling Lines not hooked up

Visual Inspection Visual Inspection

10

Visual Inspection

Part inspection

Wrong material

Incorrect Mechanical Properties Cosmetic Defects

Wrong material loaded in hopper

Work instruction with lot # material usage log Visual inspection

48

None

(10 being the LEAST Confident)

Flow Paths

A Graphical Representation of a Process

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 must be addressed on the Control Plan

Control Plans

Lists Visual / Dimensions to check How to check them

The Control Check Fixtures a sample and Plan How large should explains befrequency of checks to do if listed here) what you along with what find defective documents to use product

Now, put them together

The steps or dimensions on the FMEA, Flow Path and Control Plan are to be itemized with the numbering system corresponding on all three documents

The documents described

Are all tools to ensure we make a product that meets Customer Expectations Make up part of the PPAP (Production Part Approval Process) Completion of the PPAP requires a dimensional layout and a Warrant at the minimum And, any other documents required by the Customer

APQP

Helps prevent us from making mistakes by a systematic 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 this introductory presentation

For those of you still awake

This ends the Presentation

Thank

you for you attendance

Q&A SESSION