The risk analysis methodology that ensures operational excellence and compliance with the IATF 16949 standard
— News
In the automotive industrial landscape, preventing non-conformities is a critical factor in ensuring final product quality. Iglom has implemented an advanced Process Failure Mode and Effects Analysis (PFMEA) system, a structured risk assessment methodology that identifies, analyzes, and prevents potential failure modes in production processes, making a decisive contribution to achieving IATF 16949:2016 certification.
What is PFMEA
PFMEA is a structured methodology that analyzes a production process to identify:
- how a problem could occur (potential failure modes),
- why it could occur (causes),
- what consequences it could have on the product or the customer (effects),
- which controls and actions can reduce the risk.
The goal is to turn analysis into operational decisions: controls, preventive measures, and reaction criteria consistent with the level of criticality identified. Guidelines for developing an FMEA (including PFMEA) are described in the AIAG & VDA manual, which represents the most widely adopted methodological standard in the automotive sector.
PFMEA and the prevention of non-conformities
In quality management, a non–conformity is defined as the failure to meet a requirement. An effective approach therefore requires tools that allow action before a deviation turns into a defect or a customer complaint.
PFMEA supports prevention because it:
- makes process weaknesses explicit (where defects may originate),
- enables the definition of specific and measurable controls,
- supports the continuous updating of control measures based on evidence (scrap, complaints, audits, process changes).
How PFMEA translates into process controls
PFMEA is not just a document: its value depends on the ability to convert analysis into a coherent control system.
In practice, a well-managed PFMEA leads to the definition of:
- preventive controls (e.g. process standards, set-up procedures, process parameters, training),
- detection controls (e.g. in-line inspections, measurements, sampling, testing),
- corrective and preventive actions in case of deviation,
- prioritization criteria (where risk requires greater attention).
The role of PFMEA in the IATF 16949 journey
Within an automotive quality management system, PFMEA helps demonstrate a structured approach to process risk management, with particular focus on:
- defect prevention,
- process robustness,
- traceability of decisions and actions,
- continuous improvement.
From a regulatory perspective, the reference standard is IATF 16949, which defines quality management system requirements for the automotive sector.
Iglom’s approach
In line with the requirements of the automotive market and within the IATF 16949 certification pathway, Iglom has implemented PFMEA as a structured method to:
- analyze process risks,
- define targeted controls,
- prevent non-conformities and defects in the final product,
- maintain an evidence-based approach focused on continuous improvement.
