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    Standard Operating Procedure: A Process Failure Mode Effects Analysis (PFMEA)

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    Nikhil Singla
    The document discusses standard operating procedures (SOPs) and process failure mode and effects analysis (PFMEA). It then describes a control plan and how it is linked to PFMEAs. A PFMEA identifies potential process failures and assesses their severity, occurrence, and detection. It calculates a risk priority number to determine which issues require corrective action. A control plan then establishes methods to control risks identified in the PFMEA, including control factors, specifications, measurement systems, sampling procedures, and reaction plans. It is a living document that should be updated as processes and requirements change.

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    Standard Operating Procedure: A Process Failure Mode Effects Analysis (PFMEA)

    Uploaded by

    Nikhil Singla
    218 views2 pages
    The document discusses standard operating procedures (SOPs) and process failure mode and effects analysis (PFMEA). It then describes a control plan and how it is linked to PFMEAs. A PFMEA identifies potential process failures and assesses their severity, occurrence, and detection. It calculates a risk priority number to determine which issues require corrective action. A control plan then establishes methods to control risks identified in the PFMEA, including control factors, specifications, measurement systems, sampling procedures, and reaction plans. It is a living document that should be updated as processes and requirements change.

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    sop

    Original Title

    Standard Operating Procedure

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    The document discusses standard operating procedures (SOPs) and process failure mode and effects analysis (PFMEA). It then describes a control plan and how it is linked to PFMEAs. A PFMEA identifies potential process failures and assesses their severity, occurrence, and detection. It calculates a risk priority number to determine which issues require corrective action. A control plan then establishes methods to control risks identified in the PFMEA, including control factors, specifications, measurement systems, sampling procedures, and reaction plans. It is a living document that should be updated as processes and requirements change.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    218 views2 pages

    Standard Operating Procedure: A Process Failure Mode Effects Analysis (PFMEA)

    Uploaded by

    Nikhil Singla
    The document discusses standard operating procedures (SOPs) and process failure mode and effects analysis (PFMEA). It then describes a control plan and how it is linked to PFMEAs. A PFMEA identifies potential process failures and assesses their severity, occurrence, and detection. It calculates a risk priority number to determine which issues require corrective action. A control plan then establishes methods to control risks identified in the PFMEA, including control factors, specifications, measurement systems, sampling procedures, and reaction plans. It is a living document that should be updated as processes and requirements change.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 2

    Standard Operating Procedure

    Standard Operating Procedure, or SOP is a set of step-by-step instructions to achieve a


    predictable, standardized, desired result often within the context of a longer overall process.
    SOP, is used in a variety of different contexts, including healthcare, aviation, engineering,
    education, industry, and military.

    A Process Failure Mode Effects Analysis (PFMEA)


    A Process Failure Mode Effects Analysis (PFMEA) is a structured analytical tool used by an
    organization, business unit, or cross-functional team to identify and evaluate the potential
    failures of a process. PFMEA helps to establish the impact of the failure, and identify and
    prioritize the action items with the goal of alleviating risk. It is a living document that should be
    initiated prior to process of production and maintained through the life cycle of the product.

    1.

    2.

    3.
    4.

    PFMEA evaluates each process step and assigns a score on a scale of 1 to 10 for the following
    variables:
    Severity assesses the impact of the failure mode (the error in the process), with 1
    representing the least safety concern and 10 representing the most dangerous safety concern.
    In most cases, processes with severity scores exceeding 8 may require a fault tree analysis,
    which estimates the probability of the failure mode by breaking it down into further subelements.
    Occurrence assesses the chance of a failure happening, with 1 representing
    the lowest occurrence and 10 representing the highest occurrence. For example, a score of 1
    may be assigned to a failure that happens once in every 5 years, while a score of 10 may be
    assigned to a failure that occurs once per hour, once per minute, etc.
    Detection assesses the chance of a failure being detected, with 1 representing the
    highest chance of detection and 10 representing the lowest chance of detection.
    RPN Risk priority number = severity X occurrence X detection. By rule of thumb, any
    RPN value exceeding 80 requires a corrective action. The corrective action ideally leads to a
    lower RPN number.

    Control Plan
    Control Plans assure a system is in place to control the risks of the same
    failure modes as identified in the PFMEA. While Control Plans can be
    developed independently of PFMEAs, it is time and cost-effective to link
    Control Plans directly to PFMEAs.

    The primary intent of Control Plans is to create a structured approach for


    control of process and product characteristics while focusing the
    organization on characteristics important to the customer.

    A Control Plan does assure well thought-out reaction plans are in place in
    case an out-of-control condition occurs and provides a central vehicle for
    documentation and communication of control methods.

    Special attention is typically given to potential failures with high RPNs and
    those characteristics that are critical to the customer.

    A Control Plan deals with the same information explored in a FMEA plus
    more. The major additions to the FMEA needed to develop a Control Plan
    are:

    Identification of the control factors.

    The specifications and tolerances.

    The measurement system.

    Sample size.

    Sample frequency.

    The control method.

    The reaction plan.

    Dont let Control Plans become static.

    Just like work instructions, make Control Plans a living document.

    As changes in product or process characteristics, specifications,


    measurements systems, sampling, control methods, or the reaction plan are
    identified, update the control plan.

    Use the revision as a communication tool to spread the word of the


    changes to the supply chain.

    By making the FMEA a living document, you can be sure that potentials for
    failure are continually being eliminated or reduced.

    At JCB I along with my team member prepared these documentation of


    2DX King Post Carriage which is new to JCB Ballabhgarh as earlier JCB
    Jaipur was responsible for the same.

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