Quality management
Quality management in PLM: FMEA and FMECA – risk assessment where product and quality meet
By Fredrik Øyen, PLM Engineer · 26 February 2026
While SCAR and CAPA address incidents and actions, FMEA and FMECA come at an earlier stage in quality management: prevention through systematic risk analysis.
When risk management is carried out in PLM – rather than in spreadsheets – the company gains a living database of failure modes, causes and effects that follows the product throughout its lifecycle.
What are FMEA and FMECA – in Norwegian?
FMEA – Failure Mode and Effects Analysis
A structured method for identifying:
- how something can fail (failure mode)
- why it can happen (causes)
- what the consequences will be (effects)
The aim is to prioritise risks and implement actions.
FMECA – Failure Mode, Effects and Criticality Analysis
This is an extended FMEA in which risk is not only assessed, but quantified through a criticality assessment (often using a risk matrix or a criticality number).
In short:
FMEA = structured identification of risks
FMECA = FMEA + assessment of criticality
Why PLM is the natural place to carry out FMEA/FMECA
In traditional processes, FMEA often ends up in an Excel spreadsheet that no one looks at again.
In Fusion Manage, FMEA can be:
- integrated into the product structure
- accessible to all relevant disciplines
- continuously updated through SCAR and CAPA
- a basis for automated risk prioritisation
Benefits of FMEA/FMECA in a cloud-based PLM solution
1. Dynamic – not static.
Risks are updated as the product changes.
2. Knowledge reuse.
Failure modes from one variant can be reused in the next.
3. Linked to non-conformances and actions.
When a SCAR or CAPA identifies a new risk, the FMEA is updated automatically.
4. Better audits.
The auditor gains an overview of causes, assessments and actions in a single system.
FMEA, FMECA and PLM – a unified approach
With everything brought together in PLM, the company gains a complete quality loop:
Risk analysis (FMEA/FMECA) → Non-conformance (NCR) → SCAR/CAPA → Updated risk → Robust product
This is the core of connected quality management – a process in which nothing exists in isolation, and learning and improvement happen in real time.