Six Sigma is a process improvement methodology that has been used across almost all industries for more than 25 years. Developed for manufacturing at Motorola and made popular by Jack Welch and General Electric, Six Sigma is a rigorous and statistically-driven approach to quality improvement, cost reduction, and business performance.
Six Sigma has its roots in statistical methods and earlier Total Quality Management (TQM) practices. Six Sigma is often combined with Lean, in practice, under the banners of “Lean Sigma” or “Lean Six Sigma” since they are both data-driven, systematic improvement methods and there is overlap in the use of basic statistical methods.
Typically, formal Six Sigma projects are run by specially-trained and formally-certified “Belts,” such as Green Belts, Black Belts, or Master Black Belts using one of two frameworks called DMAIC and DMADV. These methodologies are both used to eliminate defects through data intensive approaches.
This methodology is best put to use when a product or process currently exists at the company, but fails to meet performance expectations or otherwise leaves customers unsatisfied.
DMAIC stands for:
Define: The goals of the project and the customer deliverables
Measure: The current performance of the process
Analyze: The defects to find the root cause
Improve: The process, generally by resolving defects
Control: The performance of future processes
This methodology is best put to use when either the existing product or process has already been optimized, yet still does not meet the customer’s requirements, or there is no existing product or process within the company, and one must be developed.
DMADV stands for:
Define: The goals of the project and the customer deliverables
Measure: And determine the needs of the customer
Analyze: The options to meet the customer’s requirements
Design: A detailed process for meeting the customer’s requirements
Verify: The performance and ability of the design
Corrective and Preventative Action (CAPA) systems often serve as the foundation of Six Sigma and other cost reduction and process improvement efforts. This practice allows the leaders of an organization to access many aspects of daily business processes and adjust various factors with the intention of improving overall business productivity.
CAPA brings about improvements to an organization’s processes, driven by the desire to remove causes of deficiencies or other undesirable situations; these actions can be reactive, hence Corrective Action, or preemptive, Preventative Action. The success of CAPA implementation is largely dependent on an understanding of performance indicators, as well as the ability to use those indicators to identify performance non-conformities.
The purpose of the CAPA system is to function as a feedback loop, identifying and investigating quality problems. It aims to correct nonconforming products and other qualities problems, while preventing re-occurrence of those issues and eliminating the potential causes of potential issues.
Production & Process Control, in which the latest product design is to be perfectly reproduced.
Material Controls
Equipment & Facilities Control
Records, Documents, & Change Control
Repetitive or critical non-conformities
Process Issues
Equipment Issues
Audits or complaints
Incomplete or deficient procedures
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