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Failure Mode and Effect Analysis (FMEA), also called “Potential Failure Modes and Effects
Analysis” further as “Failure Modes, Effects and Criticality Analysis (FMECA)” could be a
systematic technique for distinctive attainable failures that cause the best overall risk for a
method, product, or service that might embody failures in design, producing or assembly lines.
A process analysis tool, it depends on identifying:
• Failure mode: One of the ways in which a product can fail; one of its possible deficiencies
or defects
• Effect of failure: The consequences of a particular mode of failure
• Cause of failure: One of the possible causes of an observed mode of failure
• Analysis of the failure mode: Its frequency, severity, and chance of detection
Types of FMEA
1. Design FMEA
- is a methodology used to analyze risks associated with a new, updated or modified
product design and explores the possibility of product/design malfunctions,
reduced product life, and safety and regulatory concerns/effects on the customer
derived from:
2. Process FMEA
- is a methodology used to discovers risks associated with process changes including
failure that impacts product quality, reduced reliability of the process, customer
dissatisfaction, and safety or environmental hazards derived from the 6Ms:
• A product is having its design updated or is getting a new design (includes new products
altogether)
• A service is being transformed with additional, new, modified steps
• A process or a supply chain is being altered, changed and modified
• You are developing new or updated control plans.
• You are creating improvement goals.
• You are analyzing failures of existing processes, products or services.
• There are periodic checks during the life of a product, service or process.
FMEA Benefits
As a tool, Failure Mode and Effect Analysis is one of the most effective low-risk
techniques for predicting problems and identifying the most cost-effective solutions for
preventing problems. As a procedure, FMEA provides a structured approach for evaluating,
tracking and updating design/process developments. It provides a format to link and maintain
many company documents. Like a diary, FMEA is started during design/process/service
conception and continued throughout the saleable life of the product. It is important to
document and assess all changes that occur which affect quality or reliability.
When FMEA is done by a team, the payback is realized by identifying potential failures
and reducing failure cost because of the collective expertise of the team in understanding how
the design/process works. FMEA is highly subjective and requires considerable guesswork on
what may and could happen, and means to prevent this. If data is not available, the team may
design an experiment, collect data, or simply pool their knowledge of the process.
FMEA Key Concepts
FMEA provides a structured approach to identifying and prioritizing potential failure
modes, taking action to prevent and detect failure modes and making sure mechanisms are in
place to ensure ongoing process control.
FMEA helps to document and identify where in a process lies the source of the failure
that impacts a customer’s CTQ’s
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