There are numerous high-profile examples of product recalls resulting from poorly designed products and/or processes. These failures are debated in the public forum with manufacturers, service providers and suppliers being depicted as incapable of providing a safe product. Failure Mode and Effects Analysis, or FMEA, is a methodology aimed at allowing organizations to anticipate failure during the design stage by identifying all of the possible failures in a design or manufacturing process.
What is Failure Mode and Effects Analysis (FMEA)
Failure Mode and Effects Analysis (FMEA) is a structured approach to discovering potential failures that may exist within the design of a product or process.
Failure modes are the ways in which a process can fail. Effects are the ways that these failures can lead to waste, defects or harmful outcomes for the customer. Failure Mode and Effects Analysis is designed to identify, prioritize and limit these failure modes.
FEMA Software is not a substitute for good engineering. Rather, it enhances good engineering by applying the knowledge and experience of a Cross Functional Team (CFT) to review the design progress of a product or process by assessing its risk of failure.
There are two broad categories of FMEA, Design FMEA (DFMEA) and Process FMEA (PFMEA).
Design FEMA Software
Design FMEA (DFMEA) explores the possibility of product malfunctions, reduced product life, and safety and regulatory concerns derived from:
- Material Properties
- Interfaces with other components and/or systems
- Engineering Noise: environments, user profile, degradation, systems interactions
Process FEMA Software
Process FMEA (PFMEA) discovers failure that impacts product quality, reduced reliability of the process, customer dissatisfaction, and safety or environmental hazards derived from:
- Human Factors
- Methods followed while processing
- Materials used
- Machines utilized
- Measurement systems impact on acceptance
- Environment Factors on process performance
Why Perform Failure Mode and Effects Analysis (FMEA)
FMEA is one of many tools used to discover failure at its earliest possible point in product or process design. Discovering a failure early in Product Development (PD) using FMEA provides the benefits of:
- Multiple choices for Mitigating the Risk
- Higher capability of Verification and Validation of changes
- Collaboration between design of the product and process
- Improved Design for Manufacturing and Assembly (DFM/A)
- Lower cost solutions
- Legacy, Tribal Knowledge, and Standard Work utilization
How to Perform Failure Mode and Effects Analysis (FMEA)
FMEA is performed in seven steps, with key activities at each step. The steps are separated to assure that only the appropriate team members for each step are required to be present. The FMEA approach used by Quality-One has been developed to avoid typical pitfalls which make the analysis slow and ineffective. The Quality-One Three Path Model allows for prioritization of activity and efficient use of team time.
There are Seven Steps to Developing an FMEA:
- FMEA Pre-Work and Assemble the FMEA Team
- Path 1 Development (Requirements through Severity Ranking)
- Path 2 Development (Potential Causes and Prevention Controls through Occurrence Ranking)
- Path 3 Development (Testing and Detection Controls through Detection Ranking)
- Action Priority & Assignment
- Actions Taken / Design Review
- Re-ranking RPN & Closure
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