Failure Mode and Effects Analysis

Failure Mode and Effects Analysis (FMEA) is an important technique in quality management for the manufacturing industry. It involves systematically identifying potential failure modes in products or processes and evaluating their impact on overall quality. By prioritizing these failures based on severity, occurrence and detectability, FMEA helps manufacturers address the most critical issues that could affect products and processes and meet customer satisfaction.

In manufacturing, FMEA is applied during both the design phase (Design FMEA) and the process phase (Process FMEA). Design FMEA aims to prevent failures by assessing risks in the product design before production starts, while Process FMEA focuses on identifying and mitigating risks in the manufacturing process itself. This proactive approach allows manufacturers to implement corrective and detective actions early, reducing the likelihood of defects and ensuring a smoother production flow.

FMEA software tools enhance this process by providing a structured framework for documenting and analyzing potential failures. These tools facilitate the organization of complex systems, enable efficient risk assessments and support the prioritization of corrective and detective actions. By integrating with other quality management systems, FMEA software ensures that all relevant information is accessible and up-to-date, helping manufacturers maintain high standards of quality and compliance.

Related products: Opcenter X Quality | Teamcenter Quality & Compliance

Assess risks for complex designs and processes
FMEA helps assess risks in complex designs and processes in a structured manner, allowing for sorting data at all hierarchies and levels. It creates a systematic view of the correlation between different components within systems and subsystems, with their functions, failure modes and effects.

Adhere to quality standards
FMEA enables you to perform risk assessments by following best practices and industry standards, including evaluating the risk priority number (RPN) or the action priority (AP) level to identify priorities and support the decision-making process. It assists in coordinating and controlling corrective and detective actions for continuous improvement.

Manage FMEA throughout the product lifecycle
Combining quality project management with FMEA allows you to organize people and tasks around the FMEA process in a project, assess and reduce identified risks using action tracking and alert mechanisms and then use FMEA results for generating the control plan for product and process validation.

Apply lessons learned
You can collect FMEA data in a comprehensive knowledge database and apply lessons learned to new tasks. These capabilities enable you to shorten the development process cycle while adhering to quality output and project deadlines.

Integrate FMEA activities
FMEA can be integrated with other quality management activities, including advanced product quality planning (APQP), process flow charts (PFC), control plans, statistical process control (SPC) and problem-solving process (PSP).