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.
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:
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.
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).
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.
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.