Quality as a concept and business practice is defined. Applicable standards and regulations for various manufacturing and service industry sectors will be introduced. Lean manufacturing and six sigma concepts and how they tie into the professional framework will also be discussed.
ISO 9001:2008, ISO 13485:2003 and FDA Current Good Manufacturing Practices are discussed in detail. Students will be introduced to and apply auditing principles as they relate to the standards. Confidentiality professional practices will be presented.
This introduction to Applied/Industrial Metrology will cover measurement fundamentals and calibration. Students will be introduced to accuracy and precision and how they are affected by the equipment, environment, and measurement systems. There will be limited hands-on time for common physical measurement tools.
In this module, measurement fundamentals discussed in Module 3 will be expanded to include inspection methods and sampling plans. Evaluating processes to determine when, where and how to take a sample will be covered. Understanding material specifications and component drawings will also be discussed
A general review of shop math and statistics will be covered. The student will be provided an overview of how to evaluate the data gathered via inspection to make product release decisions. Reporting the data and using Excel® in the workplace will also be discussed. Students will participate in small exercise that explores data collection and analysis.
Quality Control throughout industry is typically the group that determines the acceptability of both raw materials (components) used to manufacture the products and whether the product can be shipped. This module will explore how this is applied in the workplace. Teamwork, conflict resolution and communication skills will be presented and demonstrated.
Throughout industry understanding and solving problems is a necessary skill. This module will look at commonly used tools such as the fishbone diagram, who/what/where/when/why/how and 5-whys and their use in evaluating situations, leading toward solutions. Corrective Action and Preventive Action systems are required by both ISO and FDA.
An integral part of the quality system, validation is a structured method for documenting and demonstrating that processes and products function as intended. The requirements for design, installation, operation and performance will be covered.
Lean manufacturing focusses on the elimination of waste, whereas Six Sigma focuses on the elimination of defects. These business philosophies will be discussed in reference to how they function within the quality system.