Failure Analysis

Failure analysis is a systematic procedure for identifying, investigating, and evaluating the causes of deviations, nonconformities, or undesired events. Its objective is the causal clarification of how failures arise and what effects they have, in order to derive sustainable corrective and preventive actions. Within quality management, failure analysis is a central element of effective quality assurance.

Terminological Classification

A failure is the non-fulfillment of a specified requirement. Failure analysis examines:

• the specific failure pattern (symptom)
• the point in time at which it arose
• the place in the process where it arose
• the underlying causes
• systemic influencing factors

A distinction must be made between failure cause and failure effect. An effective analysis does not target symptoms, but the underlying cause.

Systematic Approaches

Various methods are used for structured failure analysis, including:

• cause-and-effect diagram (Ishikawa)
• 5 Whys
• A3 methodology
• 8D report

The choice of method depends on the complexity, risk, and relevance of the deviation. In data-intensive processes, the analysis is frequently carried out in conjunction with statistical process control in order to evaluate deviations quantitatively.

Role in the Quality Management System

According to ISO 9001, organizations are obliged to take appropriate action to eliminate the causes of nonconformities. Failure analysis forms the technical basis for this. It supports:

• the derivation of effective corrective actions
• the avoidance of recurring failures
• the stabilization of processes
• continual improvement

Failure analysis is therefore not to be considered in isolation, but as part of a closed control loop of detection, evaluation, action, and verification of effectiveness.

Distinction from Related Instruments

• FMEA: preventive analysis of potential failures before they occur.
• Complaint handling: organizational handling of external complaints.
• Audit: systematic examination of management or process systems.

While FMEA has a preventive effect, failure analysis is typically reactive and relates to deviations that have already occurred.

Organizational Levels of Impact

• Operational: elimination of specific failure causes
• Tactical: adjustment of inspection plans or process parameters
• Strategic: identification of systemic weaknesses in the quality management system

Structured failure analysis promotes a fact-based corporate culture and reduces subjective attribution of blame in favor of objective clarification of causes.

FAQ – Frequently Asked Questions About Failure Analysis

What is the objective of a failure analysis?

The objective is the causal identification of the causes of a deviation in order to derive sustainable and effective actions.

Is failure analysis the same as FMEA?

No. FMEA is a preventive risk analysis. Failure analysis examines deviations that have already occurred.

Why is root cause analysis more important than treating symptoms?

Eliminating symptoms does not prevent recurring failures. Only the identification and elimination of the root cause leads to sustainable process stability.

Is failure analysis required by standards?

Standards such as ISO 9001 require the causes of nonconformities to be determined and suitable actions to be initiated. Failure analysis is the technical instrument for implementing this requirement.

Standards and Norms

Failure analysis is not a term defined by a standard in its own right, but an integral part of the normative requirements for handling nonconformities and continual improvement under ISO 9001. Industry-specific regulations may define further requirements. Further reading: Failure analysis, Root-cause analysis (Wikipedia).

Further Internal Content

• FMEA – Failure Mode and Effects Analysis
• Complaint management
• Action management in the context of a CAQ system

AI-assisted · Editing and publication: Christian Sedlag · Last updated: 28 October 2026