Failure Mode and Effects Analysis
Bottom-up technique for systematically identifying potential failures and their effects.
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). Each failure mode is commonly scored for severity, occurrence and detection, sometimes multiplied into a risk priority number (RPN), although many MedTech teams prefer action priority tables because RPNs can hide high severity risks. In medical devices, FMEA supports ISO 14971 risk analysis but does not replace it: FMEA is bottom-up and single-fault, so it can miss hazards that arise from normal use or combined faults.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.
- •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
Cross-references
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Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsTop-down deductive analysis tracing how faults can combine to cause an undesired event.
ISO 14971 distinction underpinning all medical-device risk analysis.
International standard for the application of risk management to medical devices.
More in Quality & Risk
· Same categoryAbility of a material to perform with an appropriate host response in a specific application.
Verification step confirming a corrective or preventive action actually fixed the problem.
Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance.
Process for receiving, evaluating, and responding to device complaints.
Where this term appears across MedTech Terms.
Latest in MedTech
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1MDIC Case for QualityTier 4 VerifiedMDICmdic.org
- 2FDA - Quality SystemsTier 2 VerifiedFDAfda.gov
- 3ISO 13485 Standard PageTier 1 VerifiedISOiso.org
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