Achieving a complete risk analysis: How Opcenter Quality supports the FMEA process

By Valentina Lupo

In the automotive world, manufacturing defects can have costly and serious ramifications: increased warranty costs, impaired product functionality and safety, and an inability to meet required industry standards, among other potential consequences. The ability to assess risks associated with possible product failure is essential, and failure mode and effects analysis (FMEA) is a critical tool that enables effective risk assessment.

A forward-looking approach to quality first comprehends the needs of the customer and then builds quality into the design of both product and process. Ensuring that quality is fully considered and addressed before the first finished product rolls off the production line helps to avoid changes in later product stages, which can be costly and not as effective in producing high-quality results. As a product is planned and designed, the quality team must answer numerous questions:

  • What are all the relevant characteristics of the product or process that must be considered?
  • What are the quality-critical characteristics of the product or process?
  • What are our quality targets? How can we meet them?
  • What are the potential failures, and what effects would they have on our final customer?
  • How do we communicate to top management the main concerns during the development stage? How do we define our priorities to address the risks to our stakeholders?
  • Are we involving the right expert across departments to manage product or process development?

How does Opcenter Quality support to achieve a complete risk analysis?

The FMEA process is supported by Opcenter Quality. Opcenter Quality FMEA enables quality personnel to organize complex design and processes in a tree structure supported by diagrams, which enables sorting of data at all hierarchies and levels as well as quick and efficient navigation of complex structures. Our solution helps quality teams define system elements, functions and failures. They can create links to verify failure consequences and causes as well as to induce corrective actions. The solution also provides a graphical visualization function, risk analysis and a comprehensive range of evaluations.

It is important to note that our product can support different standards for FMEA: AIAG (Automotive Industry Action Group), VDA (German Association of the Automotive Industry) and also a harmonized approach AIAG & VDA. This last approach supports the AIAG & VDA FMEA Handbook — the new automotive industry reference manual for Failure Mode and Effects Analysis. Siemens software is ready to support the new methodology, as well as the previous approaches. Quality teams developing a transition strategy from the previous standards to the new one can use supporting tools in Opcenter Quality FMEA:

  • Existing FMEA projects. Your company may maintain the previous format: calculate Risk Priority Number (RPN), view the results on standard form-sheets and assessments in a risk matrix.
  • When you are ready to apply the new FMEA harmonized approach. Opcenter Quality supports the new seven-step approach for D-FMEA and P-FMEA. There are tables for hints for risk assessment (Severity, Occurrence, Detection). The system uses the new Action Priority (AP) method to define the risk assessment. All data are visible in the new form sheet in accordance with the handbook.

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

As a module of an integrated Quality Management System (QMS) like Opcenter Quality, FMEA enables manufacturers to avoid defects prior to production, which in turn helps them achieve product quality, improved functional safety and product reliability, and reduced warranty claims and costs.

Opcenter Quality FMEA enables data collection in a comprehensive knowledge database that can be accessed from any company location, resulting in secure company standards. Project experience can be applied to new tasks, shortening the development process cycle while adhering to quality output and project deadlines.

People and tasks can be organized around FMEA in a project through the capabilities of the APQP Project Management module (available in Opcenter Quality), assessing and reducing identified risks, including an action tracking and alert mechanism, using FMEA results for control plan, closing the loop with problem-solving and complaint management (CCM) and change management process (CMP). The quality team can implement a lesson learn process across all company plants, boosting alignment across different teams.

To recap, the main benefits of Opcenter Quality FMEA are to provide:

  • Efficient management of cause and effect analysis
  • Shortened product development processes
  • Adherence to industry quality standards and project deadlines
  • Reduced warranty claims and associated costs

How does Opcenter Quality support the quality planning phase for your company?

If your company is seeking to continually improve your quality planning processes, Opcenter Quality FMEA is the answer. It supports your company with a holistic closed-loop approach to quality.

Discover Opcenter Quality today.

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This article first appeared on the Siemens Digital Industries Software blog at