Frequently Asked Questions: FMEA Management
What is FMEA?
FMEA stands for Failure Mode and Effects Analysis. FMEA is an analysis tool that provides a structured approach to identifying all possible failures in a design, a manufacturing process, or a product or service. It is used at several points in product development and manufacturing to address risk and/or to address failures of an existing process or product.
What is FMEA software?
FMEA software provides a pre-configured system for addressing FMEA procedures, automating and integrating them with key quality applications for greater reliability and efficiency.
What is the FMEA process?
The American Society for Quality (ASQ) outlines several steps for the FMEA process, including:
- Create a cross-functional team to address all areas of impact
- Identify scope of the FEMA
- Identify functions of scope
- For each function, identify ways failure could happen
- For each failure mode, identify all consequences
- Determine severity of each effect
- Determine all potential root causes
- For each cause, determine the probability of occurring
- For each cause, identify current process controls
- For each control, determine how well it can detect cause
- Calculate risk priority number
- Identify recommended actions
- Record results
For more information, visit https://asq.org/quality-resources/fmea
When should I use FMEA software?
FMEA software can be used throughout a product’s lifecycle, including:
- During design and development as a risk management tool
- Evaluating a new use for a current product
- As part of product improvements
- Analysis of nonconformances for an existing product
How can QT9 QMS help with my FMEA processes?
QT9 QMS has 25-plus interconnected modules that come standard, including FMEA Management, that seamlessly integrate with key quality applications, such as CAPA management, risk management, customer complaints and supplier management. Its cloud-based platform allows you to keep track of deviations and synchronize records with anyone, anywhere.
QT9’s QMS software is a highly rated, affordable, easy-to-use quality management system that excels at all of the processes that go into providing high-quality goods and services that are FDA and ISO compliant.
With QT9 QMS you get unlimited scalability and traceability at a great price, so you can bring quality products and services to market in the most efficient way.
