Any project has some risk associated with the organization's ability to create outcomes that meet the customer's expectations. Failure mode effects analysis (FMEA) identifies specific ways a product, service, or process may fail to meet customer expectations. It can be extremely helpful in visualizing and explicitly identifying ways to improve process performance, reliability, and safety, particularly in a new product design or process implementation. FMEA can also be used in existing processes to test the effectiveness of a proposed solution to a process problem. FMEA helps prevent likely issues by identifying and designing preventative or corrective measures.
An FMEA team typically consists of 6 to 10 people or stakeholders who analyze the voice of the customer (VOC) data and root cause information for the examined process. The FMEA tool will assist in identifying every potential failure and the likely defects within a process existing or merely proposed. The effects and risks of these failures can then be estimated and ranked using the risk priority number (RPN). The RPN is a qualitative value derived by multiplying the values assigned to the severity of impact, probability of occurrence, and likelihood of detection.
RPN = "severity of impact" × "probability of occurring" × "likelihood of detection"
Use a scale of 1–10 to assign a rating, with 10 as the highest risk and 1 as the lowest. The failure mode (defect) with the highest RPN will receive the highest priority for control and correction. Feasible actions are then determined, which will eliminate or significantly reduce anticipated process problems that are the root causes of defects.
Advantages of FMEA
- Helps accumulate knowledge from the team and its experience in identifying and preventing known defects and errors.
- The approach is logical and structured, which helps focus on the actual process areas of concern.
- Aids in identifying critical to quality (CTQ) characteristics.
Types of FMEA
- Process FMEA analyzes processes when the main criteria being evaluated is identifying failures or errors to produce a wishful requirement.
- System FMEA analyzes a proposed process for weak points during its initial design to avoid future problems or defects.
- Design FMEA analyzes the components of a process individually and focuses on the probability of failure in each component due to some fault in design, the "weak links" in a proposed process.
