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    Quality & RiskQuality SystemFMEA

    Failure Mode and Effects Analysis

    Bottom-up technique for systematically identifying potential failures and their effects.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    FMEA evaluates each component or process step to identify failure modes, their causes, effects, and severity, occurrence, and detectability ratings used to prioritize mitigation. Variants include design FMEA (dFMEA), process FMEA (pFMEA), and use FMEA (uFMEA).
    What the regulation says
    Failure Mode and Effects Analysis (FMEA) is a systematic approach recognized by regulatory bodies for identifying potential failure modes in products and processes. While not a standalone requirement, it contributes significantly to risk management activities mandated by standards like ISO 14971, which outlines a comprehensive approach to medical device risk management. The FDA, for instance, expects manufacturers to establish and maintain procedures to identify hazards and estimate risks, where FMEA can serve as a valuable tool.

    What this means in practice

    FMEA is a useful input to ISO 14971 risk management but is not, by itself, sufficient - ISO 14971 requires a top-down hazard analysis as well.

    Examples

    • A design FMEA (dFMEA) is conducted on a new infusion pump to identify potential mechanical or software failures that could lead to incorrect drug delivery.
    • A process FMEA (pFMEA) is performed on the sterilization process for a surgical instrument to identify potential steps that could lead to incomplete sterilization.
    • A use FMEA (uFMEA) is applied to a home-use diagnostic device to identify potential user errors or interactions that could lead to inaccurate results or patient harm.
    Common pitfalls
    • •FMEA alone is not sufficient to meet the requirements of a comprehensive risk management system like that described in ISO 14971, which also requires a top-down hazard analysis.
    • •Focusing solely on FMEA without considering the broader context of system-level hazards can lead to an incomplete risk profile.
    • •Incorrectly assigning severity, occurrence, or detectability ratings can result in an inaccurate prioritization of risks.
    • •FMEA can be perceived as a one-time exercise rather than an iterative process that evolves throughout the device lifecycle.
    • •Failing to link FMEA outputs directly to risk control measures and verification activities can diminish its effectiveness.

    Frequently asked questions

    The primary output of an FMEA is a prioritized list of potential failure modes, along with their causes, effects, and risk priority numbers (RPN) or equivalent scores, indicating which risks require mitigation.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    MDIC·1FDA·1ISO·1
    1. 1
      MDIC Case for Quality
      Verified
      MDICmdic.org
    2. 2
      FDA - Quality Systems
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

    Inline markers like [1] jump to the matching reference above.