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7/31/2019 APQP- In Progress
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APQPTELEFLEX MEDICAL
PROGRAMME FOR SUPPLIERS2012
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AdvancedProduct
QualityPlanning
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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!
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How do we know what the CUSTOMER
expects?
Customer Expectations
Well.they tell us.
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Customer Expectations
Quality Products
Purchase Orders
Raw Material
Specifications Drawings
Purchase
Agreements Continuous
Improvements
Good Cost
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Customer Expectations
Part Drawings and Specifications
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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
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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
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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
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Failure Mode and EffectsAnalysis
Used to evaluate RISK
Should address any Key Product Characteristicscalled out on the Drawing
POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Part Number:Customer Part Number:
Date (or ig): 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 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
lot # material usage
log
2 48 None
Cosmetic
Defects
Visual inspection
(Tool Room or
Mold Setter)
Suresh
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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 lotof material
QA 1/1/95 Rejected -
-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
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 instruction with
lot # material usage
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
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Flow Paths
A Graphical Representation of a Process
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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
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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
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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
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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
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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
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For those of you still awake
This ends the Presentation
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Q&A SESSION