Analysis methods
FMEA · IEC 60812
A bottom-up analysis of how items can fail and what happens when they do.
Failure modes and effects analysis (FMEA and FMECA)
- Category
- Analysis methods
- Scope
- International
- Edition / refs
- IEC 60812:2018
MSA output
- FMEA analysis
- Link to PLr / SIL calculations
- Word, PDF and Excel exports
What is FMEA · IEC 60812?
FMEA is a systematic, bottom-up (inductive) method for identifying how items in a system can fail, the effects of those failures and the controls in place. FMECA adds an assessment of criticality. IEC 60812:2018 describes how to plan, perform, document and maintain an FMEA, and applies to hardware, software, processes and human actions.
In functional safety, a variant called FMEDA (failure modes, effects and diagnostic analysis) is used to derive safe and dangerous failure rates and diagnostic coverage for IEC 61508, IEC 62061 and ISO 13849-1 calculations.
Who it applies to
- Design and reliability engineers
- Safety engineers supporting PL and SIL verification
- Machine builders and process equipment suppliers
- Quality teams managing design and process risk
Key requirements
- 01
Define scope and ground rules
Set the system boundary, the level of analysis and the rating criteria before starting.
- 02
Identify functions and failure modes
For each item, list its functions and the ways each function can fail.
- 03
Determine effects and causes
Record local and end effects, and the causes of each failure mode.
- 04
Identify controls
Record existing prevention and detection measures.
- 05
Prioritise
Rank by severity, likelihood and detection or by criticality. IEC 60812:2018 discusses the limitations of the traditional risk priority number and alternatives to it.
- 06
Act and maintain
Assign actions and keep the FMEA current as the design changes.
Summary for orientation only. Always refer to the current official text of FMEA · IEC 60812 and any applicable legislation.
MSA for FMEA · IEC 60812
What MSA generates
Evidence produced from your engineering inputs, traceable end to end and exported to Word, PDF or Excel.
FMEA analysis
Part of MSA’s FTA · FMEA · Bowtie capability, structured to IEC 60812 principles.
Link to PLr / SIL calculations
Failure analysis connected to the safety functions it supports.
Word, PDF and Excel exports
Worksheets in formats reviewers already use.
Frequently asked questions
What is the difference between FMEA and FTA?
FMEA works bottom-up from component failure modes to their effects. FTA works top-down from an undesired event to the combinations of failures that cause it. They are complementary.
What is the difference between FMEA and FMEDA?
FMEDA extends FMEA by classifying failure modes as safe or dangerous, detected or undetected, to calculate failure rates and diagnostic coverage for functional safety.
Does ISO 13849 require an FMEA?
ISO 13849-1 and IEC 62061 do not mandate a specific format, but an FMEA or FMEDA is a common way to justify fault considerations and diagnostic coverage.
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