APQP- In Progress

  • View
    215

  • Download
    0

Embed Size (px)

Text of APQP- In Progress

  • 7/31/2019 APQP- In Progress

    1/19

    APQPTELEFLEX MEDICAL

    PROGRAMME FOR SUPPLIERS2012

  • 7/31/2019 APQP- In Progress

    2/19

    AdvancedProduct

    QualityPlanning

  • 7/31/2019 APQP- In Progress

    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!

  • 7/31/2019 APQP- In Progress

    4/19

    How do we know what the CUSTOMER

    expects?

    Customer Expectations

    Well.they tell us.

  • 7/31/2019 APQP- In Progress

    5/19

    Customer Expectations

    Quality Products

    Purchase Orders

    Raw Material

    Specifications Drawings

    Purchase

    Agreements Continuous

    Improvements

    Good Cost

  • 7/31/2019 APQP- In Progress

    6/19

    Customer Expectations

    Part Drawings and Specifications

  • 7/31/2019 APQP- In Progress

    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

  • 7/31/2019 APQP- In Progress

    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

  • 7/31/2019 APQP- In Progress

    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

  • 7/31/2019 APQP- In Progress

    10/19

    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

  • 7/31/2019 APQP- In Progress

    11/19

    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 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

  • 7/31/2019 APQP- In Progress

    12/19

    Flow Paths

    A Graphical Representation of a Process

  • 7/31/2019 APQP- In Progress

    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

  • 7/31/2019 APQP- In Progress

    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

  • 7/31/2019 APQP- In Progress

    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

  • 7/31/2019 APQP- In Progress

    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

  • 7/31/2019 APQP- In Progress

    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

  • 7/31/2019 APQP-