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    FMEA

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    BERNARDO MALACARA
    Failure Modes and Effects Analysis (FMEA) is a systematic method to evaluate processes and identify potential failures, failure impacts, and risk priorities. It involves 10 steps: 1) reviewing the process, 2) brainstorming potential failures, 3) listing failure effects, 4) assigning severity rankings, 5) assigning occurrence rankings, 6) assigning detection rankings, 7) calculating risk priority numbers, 8) developing an action plan, 9) taking action, and 10) recalculating risk priority numbers after improvements. The analysis prioritizes failures for mitigation based on severity, occurrence likelihood, and detectability.

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    FMEA

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    BERNARDO MALACARA
    28 views4 pages
    Failure Modes and Effects Analysis (FMEA) is a systematic method to evaluate processes and identify potential failures, failure impacts, and risk priorities. It involves 10 steps: 1) reviewing the process, 2) brainstorming potential failures, 3) listing failure effects, 4) assigning severity rankings, 5) assigning occurrence rankings, 6) assigning detection rankings, 7) calculating risk priority numbers, 8) developing an action plan, 9) taking action, and 10) recalculating risk priority numbers after improvements. The analysis prioritizes failures for mitigation based on severity, occurrence likelihood, and detectability.

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    FMEA

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    Failure Modes and Effects Analysis (FMEA) is a systematic method to evaluate processes and identify potential failures, failure impacts, and risk priorities. It involves 10 steps: 1) reviewing the process, 2) brainstorming potential failures, 3) listing failure effects, 4) assigning severity rankings, 5) assigning occurrence rankings, 6) assigning detection rankings, 7) calculating risk priority numbers, 8) developing an action plan, 9) taking action, and 10) recalculating risk priority numbers after improvements. The analysis prioritizes failures for mitigation based on severity, occurrence likelihood, and detectability.

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    28 views4 pages

    FMEA

    Uploaded by

    BERNARDO MALACARA
    Failure Modes and Effects Analysis (FMEA) is a systematic method to evaluate processes and identify potential failures, failure impacts, and risk priorities. It involves 10 steps: 1) reviewing the process, 2) brainstorming potential failures, 3) listing failure effects, 4) assigning severity rankings, 5) assigning occurrence rankings, 6) assigning detection rankings, 7) calculating risk priority numbers, 8) developing an action plan, 9) taking action, and 10) recalculating risk priority numbers after improvements. The analysis prioritizes failures for mitigation based on severity, occurrence likelihood, and detectability.

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    EXPLAIN THE FMEA PURPOSE

    Failure Modes and Effects Analysis (FMEA) is a systematic, proactive method for
    evaluating a process to identify where and how it might fail and to assess the
    relative impact of different failures, in order to identify the parts of the process that
    are most in need of change.

    MENTION THE STEPS OF FMEA PROCESS


     STEP 1: Review the process:
    Use a process flowchart to identify each process component.
    List each process component in the FMEA table.
    If it starts feeling like the scope is too big, it probably is. This is a good time to
    break the Process Failure Mode and Effects Analysis into more manageable
    chunks.
     STEP 2: Brainstorm potential failure modes
    Review existing documentation and data for clues about all of the ways each
    component can failure.
    The list should be exhaustive – it can be paired down and items can be combined
    after this initial list is generated.
    There will likely be several potential failures for each component.
     STEP 3: List potential effects of each failure
    The effect is the impact the failure has on the end product or on subsequent steps
    in the process.
    There will likely be more than one effect for each failure.
     STEP 4: Assign Severity rankings
    Based on the severity of the consequences of failure.
     STEP 5: Assign Occurrence rankings
    Rate the severity of each effect using customized ranking scales as a guide.
     STEP 6: Assign Detection rankings
    What are the chances the failure will be detected prior to it occuring .

     STEP 7: Calculate the RPN


    Severity X Occurrence X Detection

    BERNARDO MALACARA RIVERA 9B


     STEP 8: Develop the action plan
    Decide which failures will be worked on based on the Risk Priority Numbers.
    Focus on the highest RPNs.
    Define who will do what by when.
     STEP 9: Take action
    Implement the improvements identified by your Process Failure Mode and Effects
    Analysis team.
     STEP 10: Calculate the resulting RPN
    Re-evaluate each of the potential failures once improvements have been made
    and determine the impact of the improvements.

    EXPLAIN THE BRAINSTORM POTENTIAL FAILURE MODES

    Why Perform Failure Mode and Effects Analysis (FMEA)

    Historically, the sooner a failure is discovered, the less it will cost. If a failure is
    discovered late in product development or launch, the impact is exponentially more
    devastating.
    FMEA is one of many tools used to discover failure at its earliest possible point in
    product or process design. Discovering a failure early in Product Development
    (PD) using FMEA provides the benefits of:
    Multiple choices for Mitigating the Risk
    Higher capability of Verification and Validation of changes
    Collaboration between design of the product and process
    Improved Design for Manufacturing and Assembly (DFM/A)
    Lower cost solutions
    Legacy, Tribal Knowledge, and Standard Work utilization

    BERNARDO MALACARA RIVERA 9B


    Ultimately, this methodology is effective at identifying and correcting process
    failures early on so that you can avoid the nasty consequences of poor
    performance.

    EXPLAIN THE ASSIGN AN OCCURRENCE RANKING FOR EACH


    FAILURE MODE
    What is the definition of “occurrence” in an FMEA?
    “Occurrence” is a ranking number associated with the likelihood that the failure
    mode and its associated cause will be present in the item being analyzed. For
    System and Design FMEAs, the occurrence ranking considers the likelihood of
    occurrence during the design life of the product. For Process FMEAs the
    occurrence ranking considers the likelihood of occurrence during production. It is
    based on the criteria from the corresponding occurrence scale. The occurrence
    ranking has a relative meaning rather than an absolute value and is determined
    without regard to the severity or likelihood of detection.

    EXPLAIN THE PRIORITIZE THE FAILURE MODES FOR ACTION

    FMEA Document Analysis


    Deciding when to take an action on the FMEA has historically been determined by
    RPN thresholds. Quality-One does not recommend the use of RPN thresholds for
    setting action targets. Such targets are believed to negatively change team
    behavior because teams select the lowest numbers to get below the threshold and
    not actual risk, requiring mitigation.
    The analysis of an FMEA should include multiple level considerations, including:
    Severity of 9 / 10 or Safety and Regulatory alone (Failure Mode Actions)
    Criticality combinations for Severity and Occurrence (Cause Actions)
    Detection Controls (Test and Control Plan Actions)
    RPN Pareto
    When completed, Actions move the risk from its current position in the Quality-One
    FMEA Criticality Matrix to a lower risk position.

    BERNARDO MALACARA RIVERA 9B


    EXPLAIN THE TAKE ACTIONS TO ELIMINATE OR REDUCE THE
    HIGH-RISK FAILURE MODE
    FMEA Relationship to Problem Solving
    The Failure Modes in a FMEA are equivalent to the Problem Statement or Problem
    Description in Problem Solving. Causes in a FMEA are equivalent to potential
    root causes in Problem Solving. Effects of failure in a FMEA are Problem
    Symptoms in Problem Solving. More examples of this relationship are:
    The problem statements and descriptions are linked between both documents.
    Problem solving methods are completed faster by utilizing easy to locate, pre-
    brainstormed information from an FMEA.
    Possible causes in an FMEA are immediately used to jump start Fishbone or
    Ishikawa diagrams. Brainstorming information that is already known is not a good
    use of time or resources.
    Data collected from problem solving is placed into an FMEA for future planning of
    new products or process quality. This allows an FMEA to consider actual failures,
    categorized as failure modes and causes, making the FMEA more effective and
    complete.
    The design or process controls in an FMEA are used in verifying the root cause
    and Permanent Corrective Action (PCA).
    The FMEA and Problem Solving reconcile each failure and cause by cross
    documenting failure modes, problem statements and possible causes.

    BERNARDO MALACARA RIVERA 9B

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