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    FMEAFailure Mode and Effects Analysis

    Definition

    Failure Mode and Effects Analysis — a structured review of how items or process steps could fail, what each failure causes and how it would be controlled.

    Editorial definition: The QHSE Standard, updated 3 October 2026 · https://qhsetech.com/glossary/fmea

    What IEC, the EPA and OSHA say about FMEA

    IEC 60812:2018, the third edition, is the international standard for failure modes and effects analysis. Its published summary says it describes how an FMEA, or its FMECA variant, is planned, carried out, recorded and kept up to date. The aim is to establish how an item or process could fail to do its job so that treatments can be identified. It identifies failure modes together with their local and global effects on the item or process, and may identify causes. Failure modes can be prioritised to support decisions. Where criticality is graded using at least the severity of consequences, the analysis is called FMECA. The standard is generic and applies to hardware, to software and to processes, including human action, and to the interfaces between them. Being generic, it gives no specific guidance for safety applications. This edition adds alternative ways of calculating risk priority numbers and a criticality matrix method. The text is not reproduced here.

    EPA guidance describes the technique as used in chemical process hazard evaluation. It examines the ways equipment fails and how the system responds, concentrating on single equipment failures and system failures, and usually produces recommendations to improve equipment reliability. It does not examine human error directly, although it considers the effect of human error on equipment. The usual output is a table giving, for each item, a description, the failure modes, the effect of each failure, existing safeguards and suggested actions. EPA adds that analysts generally assume existing safeguards do not work, and quotes AIChE that more optimistic assumptions may be acceptable if every failure mode is treated on the same basis. AIChE is quoted as saying FMEA is not efficient for listing every combination of equipment failures that leads to an accident. The two descriptions differ in scope, because the standard is generic and the EPA text is about process plants.

    OSHA's 29 CFR 1910.119(e) names FMEA as one of the acceptable techniques for the hazard analysis of covered processes in the United States. The summary here is general information, not legal or engineering advice. Sector rules, for example in automotive or medical devices, may require a particular format and are not covered.

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    What an FMEA record holds in software

    • The scope: the item, product or process step analysed, the function it must perform and the revision of the design or process documents used.
    • Each failure mode of each function, with its local and wider effects and its cause.
    • The controls in place for prevention and for detection.
    • The ratings given, with the rating scales and the method used for any risk priority number or criticality grading.
    • Actions with an owner and due date, and the result of the re-rating after the action.
    • The team members and their expertise, and the dates of the reviews.
    • Links to the documents the analysis feeds, such as a control plan, a work instruction or an inspection plan.

    FMEA, FMECA, HAZOP and fault tree analysis

    FMEA starts from a part or step and asks how it could fail and what follows. A HAZOP starts from a process parameter and asks what deviations could occur. A fault tree starts from one unwanted event and works back to its causes; EPA's guidance says FMEA or HAZOP suits systems vulnerable to single failures better. FMECA is the variant that grades criticality.

    A hypothetical example: a dosing pump on a line

    This invented case describes no real company and is meant only to show the record. A team analyses a dosing pump that adds a treatment chemical to a process stream. For the function of dosing a set quantity, one failure mode is that the pump delivers too little. The local effect is a low dose, the wider effect is untreated product moving downstream, and the cause is a worn valve. The existing control is a flow meter with an alarm. The team rates the item with the organisation's own scales and the record states the scale version, so a later reader can interpret the number.

    The highest-priority action is a weekly valve inspection with a documented limit. After the first month the team re-rates the item with the actual inspection results. The record keeps both ratings side by side, together with the links to the updated inspection plan. A reviewer also asks that every failure mode with the top severity rating be reviewed even when its priority number is low, and the record shows that review.

    Common misunderstandings about FMEA

    • A risk priority number is a prioritisation aid, not a measure of risk. IEC 60812:2018 describes more than one way to calculate it, so two analyses with the same number may not be comparable.
    • A completed worksheet does not show completeness. The analysis is only as good as the failure modes that were thought of, and EPA notes the technique is not efficient for finding combinations of failures.
    • Ratings are not facts. They are judgements on a scale, so the scale, the team and the date belong in the record.
    • An FMEA is not finished when it is signed. The standard speaks of maintaining the analysis, and a design or process change should reopen the affected rows.
    • FMEA in a plant and FMEA in product design are different uses of one method. The generic standard and the EPA process description do not cover the same ground.

    How FMEA relates to other glossary terms

    FMEA connects design and process analysis to the records that follow from it.

    • HAZOP: starts from process deviations where FMEA starts from item failures.
    • Fault tree analysis: works back from one unwanted event to its causes.
    • CAPA: an actual failure may show that an FMEA missed a mode or rated it too low.
    • Non-conformance: a nonconformity found in operation can feed back into the failure mode list.

    Records and evidence that usually exist for an FMEA

    • The worksheet with functions, failure modes, effects, causes and controls.
    • The rating scales and the method used for prioritisation.
    • The list of team members and review dates.
    • Action records with owners, due dates and the re-rating after each action.
    • Links to control plans, inspection plans and work instructions.
    • Revision history showing what triggered each update.
    • Reports in the format a customer or regulator expects, where one applies.

    What a software tool needs to capture for FMEA

    • Worksheet fields for function, failure mode, effects, cause, prevention control and detection control.
    • Rating scales stored with a version, so older ratings keep their meaning.
    • More than one prioritisation method, with the chosen method recorded on the analysis.
    • Re-rating after an action, with the earlier rating kept.
    • Links from a failure mode to the control plan, the inspection plan and any nonconformance that touched it.
    • A review prompt when a linked design, process or document revision changes.
    • Reports in the layout a customer or sector rule requires, produced from the same fields.

    Catalog profiles documenting FMEA workflows

    The FMEA rule produces this list. A listing does not establish support for the variant, rating scales or report format that a customer or regulator expects; test those in a demonstration.

    Same rule for every product: tagged “Quality Management”, “Risk Assessment”, “Risk Management”, “CAPA Management” or “Manufacturing Quality”, with a sourced FMEA capability in its record, or one the vendor stated to us, labelled as vendor-stated. Documented and conditional capabilities qualify; check the linked scope before treating a module as included.

    Ordered by how closely our sources document this process, not by quality. Sponsored placements are labelled. How lists are ordered

    All 3 matching profiles are shown. Documentation review, not hands-on testing or a claim of compliance.

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    Frequently asked questions

    Is FMEA the same as FMECA?

    IEC 60812:2018 treats FMECA as the variant in which criticality is graded using at least the severity of consequences. Check which variant your procedure or customer expects.

    Does OSHA require an FMEA?

    No. 29 CFR 1910.119(e) lists FMEA as one acceptable methodology for the process hazard analysis of covered processes, beside what-if, checklist, HAZOP, fault tree analysis and an appropriate equivalent.

    Should the risk priority number decide what to fix?

    It is a prioritisation aid. IEC 60812:2018 describes more than one way of calculating it and a criticality matrix method, so record which method was used and which scale each rating came from.

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