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. For stakeholders in the design process, understanding failure modes and effects was a manual process that 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, costs for redesign, had the potential to replace products under warranty or, in extreme cases, lawsuits.
The traditional system of assuming old designs were functional for new variants or having employees leave an enterprise, taking with them the memory of needed product information, created serious issues that were copied into newer variants, replicating problematic designs and increasing the cost to 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.
While you cannot always eliminate a failure, you can ensure the product fails in a safer manner.
FMEA prioritizes failures and action plans that seek to understand three things:
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.
But failure modes can be caused by the manufacturing process as well as the design process. 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.
With the help of Process Failure Mode and Effect Analysis (PFMEA), stakeholders in the production stage can evaluate the capabilities of a manufacturing process and identify the failure modes inherent in the process and develop plans to avoid them. Stakeholders also review the processes capabilities, compare those to the process sensitivities identified in the Design Failure Mode and Effect Analysis (DFMEA), and develop plans to ensure the process always produces and acceptable product.
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.