FMEA

What it means

FMEA, failure mode and effects analysis, systematically examines how a product or process could fail, what the consequences would be and how likely it is. Risks are scored and the most serious are prevented before production starts, when changes are cheapest.

There is design FMEA, which assesses the product design, and process FMEA, which assesses the manufacturing or service process. The method is standard in the automotive and aerospace industries but is also used in healthcare, IT and services.

Traditionally, each risk is rated for severity, occurrence and detection on a scale of one to ten, and their product gives a risk priority number. Newer methodologies set an action priority instead, so serious risks are not lost in an average. It is a tool of risk management.

How it works in practice

An FMEA is prepared by a cross-functional team, for example design, production, quality and purchasing, because each sees different risks. The team works through the product's functions or the process steps, identifies possible failures, their causes and effects for each, and proposes actions.

The result is a list of actions with owners and deadlines, such as a design change, an in-line check or error-proofing. After implementation the risks are reassessed, and the FMEA is updated whenever the product or process changes.

FMEA is preventive, whereas the 8D report and root cause analysis respond to failures that have already happened. Together they form a quality system under ISO 9001 and industry standards, which automotive customers require of their suppliers.

What to watch out for

An FMEA filled in merely to meet a customer requirement brings no benefit. What matters is that the team genuinely thinks about risks and that actions are implemented; otherwise the document only gives an illusion of control.

Relying solely on the risk number can lead to underestimating a failure of high severity that occurs rarely. Failures affecting safety or legal requirements must be addressed regardless of the overall score, because their cost can be enormous.