What is FMEA?

As we navigate through the era of connected manufacturing, called Industry 4.0, we’re faced with transforming our enterprises from something analog and siloed to something digitally connected. During the analog days, identifying potential issues with a product and the resulting impact was a very manual process. Additionally, this information was not often transferred to new variations or designs, leading to more testing failures or failures in the field. This caused increased time-to-market, unnecessary costs for redesign, and had the potential to result in the replacement of products under warranty or, in extreme cases, face lawsuits. 

Today’s process looks much different because of Failure Mode and Effects Analysis (FMEA). FMEA can be defined as the process used to identify all potential failures or risks to a system. This includes evaluating their effects and allowing design engineers to introduce risk controls that prevent or mitigate their impact. 

The traditional system of assuming old designs were functional for new variants or having employees leave an enterprise with the memory of needed product information, created serious issues that were copied into newer variants. This replicated problematic designs and in turn, increased the cost for the enterprise.

But when working with Failure Mode and Effects Analysis (FMEA), stakeholders can identify and analyze how parts might fail early in the design process and develop plans to prevent those failures. By systematically planning how a part or product may fail and how to address that failure mode, stakeholders can continuously improve their products before they’re sent to be manufactured or into the field.

Advantages of Failure Mode and Effect Analysis

This systematic approach evaluates a design from conception, through manufacturing, and out to the customer. By addressing these issues in advance, FMEA creates a robust infrastructure of information to ensure product designs work predictably in the field.

The benefits of FMEA are all encompassing: 

• Areas of concern within the process are highlighted.
• Manufacturers gain insights where future processes are adjusted accordingly.
• Processes follow a consistent system of change.
• Early corrections from FMEA prevent extended development time and unnecessary costs while also improving the quality of the process and finished product. 

• What is the severity of the failure?
• What is the probability that this failure occurs?
• What is the probability of detecting the problem?

By multiplying these three factors to create an RPN score, stakeholders can put a consistent, gradient scale against these criteria to identify the failure modes most impactful, severe, and hardest to detect. This allows stakeholders to alter the design to address the most critical issues before it goes to production.

Types of Failure Mode and Effect Analysis

If a product is designed to a certain tolerance, but built outside of that tolerance, the failure rate will increase, and can lead to costly reactionary measures, like dissembling products to fix them, causing damage to the product while fixing them, and adding overall time and expense. FMEA works to decrease the chances of these errors. FMEA can primarily be sorted into two categories: Design Failure Mode and Effect Analysis (DFMEA) and Process Failure Mode and Effect Analysis (DFMEA).

• DFMEAs are used in the designing stage to help identify and address high risk design issues and create more robust product designs. These designs improve the product quality and provide further security in preventing unexpected errors. DFMEA prevents unnecessary costs spent fixing errors during the manufacturing stage and works to create a plan that ensures the process always produces an acceptable product. 
  
  
• PFMEAs are used to identify and address high risk manufacturing process issues that can lead to quality and safety issues. PFMEA assures there are no manufacturing process variations where the product differs from expectation and assures there are no unknown hazards to be concerned about. Stakeholders in the production stage evaluate the capabilities of a manufacturing process, identify the failure modes inherent in the process, and work to develop plans to avoid them. This is critical for safety related products since undetected or introduced defects in manufacturing can lead to recalls and safety issues.

By addressing a product’s process sensitivity with the PFMEA, stakeholders can decide how to address the issue before production begins. They may add part or process inspection, buy new equipment, develop a recovery plan, and/or institute preventative maintenance programs for critical equipment. These decisions are recorded in the product’s Control Plan.

Failure Mode and Effect Analysis in the Industrial Revolution

FMEA is a set of preventative measures that are bolstered by today’s digital industrial revolution, allowing us to develop and produce robust product designs and manufacturing processes that produce high quality products. While there will always be risks and challenges in manufacturing a product, FMEA prioritizes and addresses them, providing safer, higher quality products for the present and future.

And with PLM tools like Windchill, FMEAs fit seamlessly within the digital thread to provide action plans to address design weaknesses and Control Plans, enabling stakeholders up and down the value chain to understand the controls and activities required to produce a quality product.

You can learn more about how PTC works with FMEAs by going to our Quality Management webpage.