Information Technology

Six Sigma Fundamentals

Start: TBA       Type: Evening / Weekend Classes       Duration (hr): 67



This course is an introduction to the fundamentals of Six Sigma technology and Quality Assurance Engineering. The quality of any object - product, service or process is a degree of its compliance with stated requirements to this object.The Quality Assurance (QA) is a totality of managerial and technical rules and actions intended to assure achieving these requirements at the end. Basic recommendations of how to organize product design and manufacturing processes are outlined in domestic and International standards. Documents, describing the Internal regulation of business processes within any determined company are combined in company Quality Management System (QMS). The current course introduces requirements to QMS as those are outlined in international standard ISO 9001:2000 and describes details of recommended QMS structure. In addition students will be acquaint with requirements of ISO 13485:2003 “Medical Devices-Quality management Systems-Requirements for Regulatory purposes”,  21CFR CH1 Part 820 “Quality System Regulation” and Good Manufacturing Practice (GMP) requirements outlined in this document and Medical Device directive (MDD93/42/EEC) that outlines quality system requirements for medical products introduced on European market. Inasmuch as QA involves a wide range of technical and managerial tasks, the Quality Assurance engineers need to have a wide knowledge in areas of technical sciences and their applications – electronic, mechanical and manufacturing engineering, mathematics (in particular - statistics) and to be fluently oriented in international and domestic regulations related to particular industry they work with. One of the essential properties of QA is that it is process-oriented. In other words – QA is focused to ensure that businessprocesses involved in achieving the compliance of the final product with its requirements are consistent and have conducted the most effectively. This determines a need for Quality Assurance engineers to pass through specific training that will allow auditing different business processes. Such training involves: excellent communication skills, expertise in recognizing the root cause of the problem and in addition - some psychological knowledge as long includes the techniques of - interviewing people.



The course is designed for people having initial technical background and experience in electrical, mechanical or manufacturing Engineering.

After completing this course, students should be able to work as a Quality Engineer:

  - To understand the nature of engineering approach to Quality, know the structure of the Quality System, and be familiar with the  international standards ISO 9001:2000 and ISO 13485:2003.

  - To be familiar with GMP, MDD 93/42/EEC, Risk Management process per ISO 14971:2000, safety standards UL/EEC 60601-1 including collateral standards 60601-1-1 - 60601-1-4.
  -  To be familiar with the specific techniques of Quality Audit.
  -  To know the basics of process mapping, Statistical Process Control.
  -  To know the basics of Continual Improvement processes, DMAIC approach and basics of Six Sigma approach.
  -  Grasp essential business terminology. Deeply understand the nature of engineering approach to Quality.
  -  To study the structure of the Quality System, to learn requirements of ISO 9001:2000.


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