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Significance of FMEA in Quality Control and Process Improvement

An organization’s quality control and process improvement process rest on the fault detection and problem-solving methods used by quality management professionals. Faults or defects in the process are expensive and increase the overall cost of the product or service the organization is trying to deliver to satisfy its customers. Thus, it is crucial to detect the problems in the business process early to avoid problems later.

Failure Mode and Effect Analysis (FMEA) is widely used for process analysis across many industries. This tool helps identify potential problems in the process or product in advance, especially when a product is in its design stage. FMEA also plays a significant role in the continuous improvement of products and services by analyzing the effects of the problems and finding appropriate solutions. In quality management, the FMEA tool is used by Lean Six Sigma practitioners to detect problems early and evaluate their impact on the desired objectives.

FMEA (Failure Mode and Effects Analysis)

What is FMEA?

FMEA is a methodology to identify potential failures in a process and analyze their impact on the product. Also known as “potential failure modes and effects analysis” and “failure modes, effects and critically analysis (FMECA),” the FMEA process analysis tool helps in detecting faults that will affect the result of the process. These defects can be anything from design failures to manufacturing or assembly problems. Therefore, FMEA is essential for the quality control process of an organization.

Originally started in the 1940s by the US military, this systematic approach to discovering potential problems is popular in many industries. The FMEA methodology is critical for an organization’s quality management process as it eliminates the chance of product recalls. It reduces the overall cost of production resulting from poor product designs, manufacturing defects, and assembly line faults. As a result, customers pay for the products they desire without any hidden costs, thus, adding value to the organization.

Types of FMEA

In Lean Six Sigma, the FMEA tool is used for identifying, prioritizing, and reducing defects in business processes. It helps in effective risk assessment and reviewing the design process to enhance the manufacturing or engineering process. There are two types of FMEA: DFMEA or Design FMEA and PFMEA or Process FMEA.

Design FMEA

This method of failure mode and effect analysis helps in identifying problems in products, limited product life, safety, and regulatory impact caused due to:

  • Properties of Materials used like strength, lubricity, viscosity, elasticity, etc.
  • Product Geometry
  • Tolerances
  • Interfaces with other Components and Systems
  • Engineering Noise

Process FMEA 

The process FMEA method helps identify failures that affect the product quality, reduced process reliability, safety of the workforce, and customer dissatisfaction caused due to:

  • Human factors or errors
  • Methods followed in the business process
  • Materials used in the process
  • Machine used to facilitate the process
  • Measurement metrics used for product acceptance
  • Environmental factors affecting the business process

How to do FMEA?

The FMEA tool is the most effective low-risk technique to predict problems and derive solutions for organizations that deliver products and services of the highest quality to their customers. FMEA Process involves regularly evaluating, monitoring, and reviewing the design or process developments to attain the desired results. An organization’s FMEA process will differ based on its business requirements. Generally, the process starts with identifying and prioritizing potential problems that may affect the business. After that, quality management professionals can take action to prevent the failure or reduce its impact. These processes are constantly monitored and controlled using appropriate documentation.

What is FMEA in Six Sigma?

FMEA in Six Sigma is the most cost-effective approach for preventing problems before they happen. Organizations conduct Six Sigma projects to improve their business processes and deliver value-enriched products and services to their customers. By using FMEA in Lean Six Sigma projects, organizations can estimate the impact of the defects in advance and take necessary actions to prevent or minimize them. The failure modes and effects analysis is utilized during the analyze phase of the DMAIC process of Six Sigma. It is a powerful tool for highlighting the voice of the customer and helping organizations reach their desired business objective.


Quality control and process improvement professionals understand the significance of FMEA in quality management. FMEA helps Lean Six Sigma practitioners identify and document the three parameters that determine the risk potential: detection, severity, and occurrence. Although all three elements cause customer dissatisfaction, the occurrence has the most noticeable impact. Therefore, aspiring quality management professionals should thoroughly understand FMEA, Six Sigma, and Lean Six Sigma to comprehend their importance in improving the business processes of modern organizations. Our Lean Six Sigma Green Belt Certification will help quality assurance, and control professionals use FMEA in practice to improve the business processes of their future organizations. Earning this reputed credential will help them get recognized in the quality management industry and help their organizations attain long-term growth.

Posted in Quality Management

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