Whitepaper · Quality & Risk
FMEA & Co.: methods for hazard and risk analysis
Six methods compared, when each makes sense, how to combine them and how they connect cleanly to the ISO 14971 risk analysis, without unnecessary documentation.
- 6
- methods: PHA · FTA · ETA · FMEA · HAZOP · HACCP
- ISO 14971
- framework for risk management
- Deep-dive
- into the methodological architecture of FMEA
- Reply usually within one working day
- 100% life sciences
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Inside the whitepaper
The whitepaper dispels the misconception that good risk analysis comes from using as many methods as possible, or that “failure mode” and “hazard” are the same. The benchmark is fit to the question, not the number of tools.
Classification within the ISO 14971 framework
Where hazard analysis sits within risk management and how the supporting methods connect to the final risk report.
Six methods at a glance
PHA, FTA, ETA, FMEA, HAZOP and HACCP, each with strengths, weaknesses and sensible fields of use.
Deep-dive: the architecture of the FMEA
From structural and functional analysis through the directed chain of failure mode, cause and effect to the assessment-based release decision.
Method selection and proportionality
Guiding questions for selection by risk question, product complexity and maturity, instead of regulatory over-compliance.
Meaningful method combinations
PHA + FMEA as the foundation, FMEA + FTA for critical safety questions, FTA + ETA as a cause-consequence combination.
Interface to risk analysis under ISO 14971
Why a failure mode is not a hazard, and the five requirements a robust link has to meet: clear assignability, traceable translation, consistency across changes, traceability to evidence, auditability.
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