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    Failure Modes And: Step-By-Step Failures

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    Vimala Selvaraj Vimala
    Assign Responsibility  For each recommended action, assign responsibility to a specific individual or group for implementation.  This ensures accountability and follow through.  The responsible party should be involved in developing the action plan and agree to the target completion date. 15. Indicate Actions Taken  Document the actions taken, including completion dates, to address each recommended action.  This provides a record of progress and completion.  Actions not yet addressed should be carried over to the next revision. 16. Update the FMEA  Periodically review and update the FMEA as the design

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    Failure Modes And: Step-By-Step Failures

    Uploaded by

    Vimala Selvaraj Vimala
    231 views31 pages
    Assign Responsibility  For each recommended action, assign responsibility to a specific individual or group for implementation.  This ensures accountability and follow through.  The responsible party should be involved in developing the action plan and agree to the target completion date. 15. Indicate Actions Taken  Document the actions taken, including completion dates, to address each recommended action.  This provides a record of progress and completion.  Actions not yet addressed should be carried over to the next revision. 16. Update the FMEA  Periodically review and update the FMEA as the design

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    PPT - FMEA

    Original Title

    FMEA

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    Assign Responsibility  For each recommended action, assign responsibility to a specific individual or group for implementation.  This ensures accountability and follow through.  The responsible party should be involved in developing the action plan and agree to the target completion date. 15. Indicate Actions Taken  Document the actions taken, including completion dates, to address each recommended action.  This provides a record of progress and completion.  Actions not yet addressed should be carried over to the next revision. 16. Update the FMEA  Periodically review and update the FMEA as the design

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    231 views31 pages

    Failure Modes And: Step-By-Step Failures

    Uploaded by

    Vimala Selvaraj Vimala
    Assign Responsibility  For each recommended action, assign responsibility to a specific individual or group for implementation.  This ensures accountability and follow through.  The responsible party should be involved in developing the action plan and agree to the target completion date. 15. Indicate Actions Taken  Document the actions taken, including completion dates, to address each recommended action.  This provides a record of progress and completion.  Actions not yet addressed should be carried over to the next revision. 16. Update the FMEA  Periodically review and update the FMEA as the design

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    © All Rights Reserved
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    of 31

    Failure

    modesand
    effectsanalysis(FMEA) is a step-bystep approach for identifying all
    possiblefailuresin
    a
    design,
    a
    manufacturing or assembly process, or
    a product or service.
    Failure modes means the ways,
    ormodes, in which something might
    fail.
    Things that could go wrong

    FMEA
    A structured approach to:
    Identifying the ways in which a
    product or process can fail
    Estimating risk associated with specific
    causes
    Prioritizing the actions that should be
    taken to reduce risk
    Evaluating design validation plan
    (design FMEA) or current control plan
    (process FMEA)
    2

    Types of FMEA
    System - focuses on global system
    functions
    Design - focuses on components and
    subsystems
    Process - focuses on manufacturing and
    assembly processes
    Service - focuses on service functions
    Software - focuses on software functions

    System

    Design FMEA

    Sub-System

    Component

    System

    Concept/Syst
    em FEMA
    Assembly

    Sub System

    Component
    Process
    FMEA
    System
    Manufacturin
    g

    Sub-system

    Component

    History of FMEA
    First used in the 1960s in the
    Aerospace industry during the Apollo
    missions
    In 1974, the Navy developed MIL-STD1629 regarding the use of FMEA
    In the late 1970s, the automotive
    industry was driven by liability costs to
    use FMEA
    Later, the automotive industry saw the
    advantages of using this tool to reduce
    risks related to poor quality
    5

    Benefits of FMEA

    Improved product/process quality, reliability and safety


    Reduced development time
    Fewer late changes
    Increased customer satisfaction
    Shorter time to market
    Early identification and elimination of potential
    product/process failure modes
    Improved validation process
    Reduced warranty
    Documented evidence of due care
    Improved company image and competitiveness
    6

    Disadvantages of FMEA
    Tedious for complex systems
    Human errors not included
    Environmental effects

    When to Use FMEA


    When a process, product or service is being designed
    or redesigned, afterquality function deployment.
    When an existing process, product or service is being
    applied in a new way.
    Before developing control plans for a new or modified
    process.
    When improvement goals are planned for an existing
    process, product or service.
    When analyzing failures of an existing process,
    product or service.
    Periodically throughout the life of the process,
    product or service
    8

    FMEA: A Team Tool

    Team Input
    Required

    A team approach is necessary.


    Team should be led by the Process Owner who is
    the responsible manufacturing engineer or
    technical person, or other similar individual
    familiar with FMEA.
    The following should be considered for team
    members:

    Design Engineers Operators


    Process Engineers Reliability
    Materials Suppliers Suppliers
    Customers
    9

    FMEA Inputs and Outputs

    Information
    Flow

    Inputs

    Outputs

    C&E Matrix
    Process Map
    Process History
    Procedures
    Knowledge
    Experience

    List of actions to prevent


    causes or detect failure
    modes
    FMEA

    History of actions taken

    10

    Severity, Occurrence,
    and Detection

    Analyzing
    Failure &
    Effects

    Severity
    Importance of the effect on customer
    requirements
    Occurrence
    Frequency with which a given cause occurs and
    creates failure modes (obtain from past data if
    possible)
    Detection
    The ability of the current control scheme to detect
    (then prevent) a given cause (may be difficult to
    estimate early in process operations).
    11

    Rating Scales

    Assigning
    Rating
    Weights

    There are a wide variety of scoring


    anchors, both quantitative or qualitative
    Two types of scales are 1-5 or 1-10
    The 1-5 scale makes it easier for the
    teams to decide on scores
    The 1-10 scale may allow for better
    precision in estimates and a wide variation
    in scores (most common)

    12

    Rating Scales

    Assigning
    Rating
    Weights

    Severity
    1 = Not Severe, 10 = Very Severe

    Occurrence
    1 = Not Likely, 10 = Very Likely

    Detection
    1 = Easy to Detect, 10 = Not easy to
    Detect

    13

    Calculating a
    Composite
    Score

    Risk Priority Number (RPN)


    RPN is the product of the severity, occurrence,
    and detection scores.

    Severity

    Occurrence

    Detection

    RPN

    14

    FMEA Stages
    1. Describe the product/Process
    2. Create a block diagram
    3. Complete the header on the FEMA form worksheet
    4. List Items/Functions
    5. Identify failure modes
    6. Document the failure mode
    7. Describe the effects f failure modes
    8. Identify the causes for failure
    9. Enter the probability factor
    10.Identify current controls
    11.Determine the likelihood of detection
    12.Review Risk Priority Numbers (RPN)
    13.Determine the recommended action
    14.Assign responsibility
    15.Indicate actions taken
    16.Update the FEMA

    FMEA Procedure
    1. Describe the product/process and its
    function.
    . An understanding of the product or process
    under consideration is important to have clearly
    articulated.
    . This understanding simplifies the process of
    analysis by helping the engineer identify those
    product/process uses that fall within the
    intended function and which ones fall outside.
    . It is important to consider both intentional and
    unintentional uses since product failure often
    ends in litigation, which can be costly and time
    consuming.

    2. Create a Block Diagram of the product or


    process.

    A block diagram of the product/process should be


    developed.

    This diagram shows major components or process


    steps as blocks connected together by lines that
    indicate how the components or steps are related.

    The diagram shows the logical relationships of


    components and establishes a structure around
    which the FMEA can be developed.

    Establish a Coding System to identify system


    elements. The block diagram should always be
    included with the FMEA form.

    FMEA Procedure: Complete the


    header on the FMEA Form worksheet

    4. Use the diagram to begin listing


    items or functions.

    If items are components, list them


    in a logical manner under their
    subsystem/ assembly based on the
    block diagram.

    5. Identify Failure Modes.


    A failure mode is defined as the manner in
    which a component, subsystem, system,
    process, etc. could potentially fail to meet
    the design intent. Examples of potential
    failure modes include:

    Allergic reaction
    Excessive bleeding
    Ineffective treatment
    Electrical Short or Open
    Too late to matter
    Brain damage

    6. Document the Failure Mode

    A failure mode in one component or activity can


    serve as the cause of a failure mode in another
    component/activity.
    Each failure should be listed in proper terms.
    Failure modes should be listed for function of
    each component or process step.
    At this point the failure mode should be
    identified whether or not the failure is likely to
    occur. Looking at similar products or processes
    and the failures that have been documented for
    them is an excellent starting point.

    7. Describe the effects of those failure


    modes.

    For each failure mode identified the analyst should


    determine what the ultimate effect will be.
    A failure effect is defined as the result of a failure mode on
    the function of the product/process as perceived by the
    customer.
    They should be described in terms of what the customer
    might see or experience should the identified failure mode
    occur. Keep in mind the internal as well as the external
    customer. Examples of failure effects include:

    Injury to the user


    Death
    Inability to lift
    Incontinent
    Degraded flexibility
    Skin irritation

    8. Identify the causes for each failure mode.


    A failure cause is defined as a design deficiency that may
    result in a failure.
    The potential causes for each failure mode should be
    identified and documented.
    The causes should be listed in proper terms and not in
    terms of symptoms. Examples of potential causes include:

    Improper size prosthesis


    Improper installation
    Contamination
    Bad procedures/conditions
    Improper alignment
    Excessive muscle damage

    9. Enter the Probability factor.

    A numerical weight should be


    assigned to each cause that
    indicates how likely that cause is
    (probability of the cause occurring).
    A common scale uses 1 to represent
    not likely and 10 to indicate
    inevitable.

    10. Identify Current Controls (design or


    process).

    Current Controls (design or process) are the mechanisms


    that prevent the cause of the failure mode from occurring
    or which detect the failure before it reaches the Customer.

    The analyst should now identify testing, analysis,


    monitoring, and other techniques that can or have been
    used on the same or similar products/ processes to detect
    failures.

    Each of these controls should be assessed to determine


    how well it is expected to identify or detect failure modes.
    After a new product or process has been in use previously
    undetected or unidentified failure modes may appear.

    The FMEA should then be updated and plans made to


    address those failures to eliminate them from the
    product/process.

    11. Determine the likelihood of


    Detection.
    Detection is an assessment of the
    likelihood that the Current Controls (design
    and process) will detect the Cause of the
    Failure Mode or the Failure Mode itself, thus
    preventing it from reaching the Customer.
    Based on the Current Controls, consider the
    likelihood of Detection using the following
    table for guidance.

    12. Review Risk Priority Numbers (RPN).

    The Risk Priority Number is a


    mathematical product of the numerical
    Severity, Probability, and Detection ratings:

    RPN = (Severity) x (Probability) x


    (Detection)

    The RPN is used to prioritize items than


    require additional quality planning or
    action.

    13. Determine Recommended Action(s)


    To address potential failures that have a high RPN.
    These actions could include

    Specific inspection,
    testing or quality procedures;
    selection of different components or materials;
    de-rating;
    limiting environmental stresses or operating range;
    redesign of the item to avoid the failure mode;
    monitoring mechanisms;
    performing preventative maintenance; and
    inclusion of back-up systems or redundancy.

    14. Assign Responsibility

    Assign Responsibility and a Target


    Completion Date for these actions.
    This makes responsibility clear-cut
    and facilitates tracking.

    15. Indicate Actions Taken.

    After these actions have been


    taken, re-assess the severity,
    probability and detection and
    review the revised RPN's. Are any
    further action(s) required?

    16. Update the FMEA


    Update the FMEA as the design or
    process changes, the assessment
    changes or new information
    becomes known.

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