Enhancing evaluation of potential risks with FMEA methodology

Design and manufacturing defects can have expensive and serious implications: amplified warranty costs, diminished product functionality and safety, and an incapacity to meet essential industry standards, among other potential consequences. The ability to evaluate risks associated with possible product or process failure is essential, and failure mode and effects analysis (FMEA) is a critical tool that enables effective risk assessment. More and more industries are applying what the Automotive and Heavy Equipment companies have implemented for years: a structured tool to define, measure and control risk around design and manufacturing.

FMEA is a methodology that enables companies to assess risks associated with possible product failure. The damage caused by potential defects can often be linked to increased warranty costs, impaired product functionality and safety and an inability to meet required industry standards, among other potential consequences.

A new product begins its lifecycle as a requirement. So, it’s fundamental to consider all requirements of the customer and then build quality into the design of both product and process. Quality requirements need to be fully addressed before the final product rolls off the production line. It helps to avoid changes in later product phases, which can be expensive and not as effective in delivering high-quality results. The FMEA provides the toolset to identify and mitigate risks in the virtual product and process structures.

How does it support to achieve a comprehensive risk analysis?

The FMEA is a cross-functional methodology touching the entire product realization process. An advanced FMEA solution is one of the most important tools a company can use to avoid product defects and process errors, so it is possible to distinguish between Design FMEA (D-FMEA) and Process FMEA (P-FMEA).

The FMEA Core team can define system elements, functions and failures both for product and process. In case of Process FMEA, it is important to create a breakdown of the manufacturing operations.

Several automotive standards and guidelines provide directions about the methodology: AIAG (Automotive Industry Action Group), VDA (German Association of the Automotive Industry) and the latest harmonized approach AIAG & VDA, too.

There are differences among standards. If we focus on the latest one, the harmonized AIAG and VDA standard, the risk assessment is performed with action priority (AP) methodology, which replaces the risk priority number (RPN). The new method considers all 1,000 possible combinations of severity, occurrence and detection (S, O and D). Action priority was created to give more emphasis on severity first, then occurrence and then detection. The RPN alone is not a suitable to determine the need for more actions because the RPN assigns equal weight to S, O and D.

Realizing the benefits of FMEA process supported by a closed-loop solution

Siemens builds its systems to support digital transformation across the entire product lifecycle. FMEA is also involved as part of the process. This holistic vision allows manufacturers to evaluate effects caused by potential defects and risks early in the planning phase by considering all the relevant domains and stages.

Leveraging on the Teamcenter collaboration platform, the value of analysis is extended due to the possibility to direct access to all engineering data like BOMs, BOPs, drawings and 3D models. People and tasks can be organized around FMEA in a project by using the capabilities of project management, assessing identified risks and using an action tracking mechanism. Residual risks are managed through the Control Plan with inspection plans for critical characteristics to be checked. Any deviations on the real product are recorded in a non-conformance and resolved through problem solving directly liked to an effective change management process.

Behind the advantages of the methodology, it is fundamental to collect data in a comprehensive knowledge database that can be accessed from all relevant experts. Previous experience can be applied to new projects to shorten the development process cycle and reduce defects at the beginning of the production cycle.

To find out more about quality management systems that support the above processes, watch our new video and visit our “Quality Planning” page.