Failure Mode Effect Analysis (FMEA) is a tool used to predict failures before they happen, and more importantly, allow for corrective action to be taken such as modifying the design or the process. The FMEA process originated in the automotive industry to improve vehicle quality and customer satisfaction. It has now become a standard in medical device, industrial and consumer goods product development for the same reasons. The FMEA process takes a no-nonsense, critical look at designs at the key milestone steps to look for potential failures in the design or manufacturing process before they begin to cost money or lost production.
How FMEAs work
Zebulon Solutions offers two variants of FMEAs, Design Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analyses (PFMEA). In either case we review the design or production process with our customer step by step and rate possible failures for Severity, Occurrence and Detection based on industry standards. A level of critical grade will be given based on the potential of the failure. A Risk Priority Number (RPN) is then generated showing the most urgent potential problems with the design / process that will require attention. A typical FMEA will take a minimum of two days; for complex systems, a week or more. As described above, key subject matter experts in the design / process areas are critical to drive the actual content review. A typical FMEA is a lock-the-doors / phones-off /no-internet type of working meeting After a FMEA is complete, the real work begins. It is critical to follow up on the potential failure modes that are identified during the FMEA. The Risk Priority Number, however, provides an easy to rank order priorities. Note that Zebulon Solutions’ role is predominately that of a facilitator. We drive the process, keep everyone focused, and provide templates and score sheets. We help the team to navigate through the overall process to reach the final goal of finding potential failures before they happen. The main content, however, needs to come from the participation of key team members from our customer and their development / manufacturing partners. In situations where Zebulon Solutions is also supporting other aspects of the program we can support of course, but in practice this is a team process, not something we can just hand over a report on. Regardless of where we are reviewing core ME, HW or SW design, end of line test process or final assembly, the FMEA review is the tool that must be used to ensure that everything has been reviewed prior to releasing to mass production. Without it the only alternative is to wait for the field failures to come into the repair depot. Zebulon Solutions offers two variants of FMEAs, Design Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analyses (PFMEA).
What is required for a Design FMEA (DFMEA)?
- Concept direction
- Preliminary Bill of Materials
- Pre-validation prototypes (if available)
- Undivided attention of design engineers and program managers.
What is required for a Process FMEA (PFMEA)?
- Preliminary Process Flow diagram
- Preliminary Control Plan
- Validated prototype parts
- Undivided attention of design engineers and industrialization team
Sample RPN Score Sheet