Quality Systems Intensive

Program description: 
This Quality Systems Intensive four-module program, prepared by Gretchen Ingvason at Mount Wachusett Community College, provides students with general knowledge related to regulated and international quality systems (ISO 9001 and US FDA), continuous improvement techniques, and the tools used to have a positive impact on an organization's bottom line. Students will learn the fundamentals of quality assurance /quality control used in current manufacturing and service industries. Students will also learn about formal procedures and defined processes as a means to control quality, along with methods to evaluate quality. The procedures and processes covered include quality control/quality assurance concepts, measurements and associated error/uncertainty, calibration, statistical process controls, and lean six sigma practices. This program includes the following outcomes: 

• Demonstrate the ability to utilize the basic seven quality tools: Pareto chart, flow chart, check sheets, control charts, cause and effect diagrams, histograms and scatter diagrams. 
• Demonstrate an ability to recognize ISO9001:2015 and US FDA 21CFR pharma (210/211) and medical device (820) quality systems. 
• Identify and apply sampling and inspection methods as fundamental quality control techniques. 
• Demonstrate the ability to statistically review data. 
• Express the principles of validation and qualification. 
• Describe the principles of lean manufacturing and six sigma improvement techniques. 

Program contents:
Program materials include four modules. The first module provides an overview of the program and covers the following topics: concepts in quality, quality in manufacturing, what is quality, customer vs. supplier, process flow - manufacturing, quality organizations, manufacturing, history of quality, scientific management, and more. 

Module 2 covers the following topics: measurements, specifications, drawing, geometric dimension and tolerance, understanding the drawings, metrology, measurement fundamentals, inspection, seven quality tools, and more.

Module 3 covers the following topics: analysis, shop math, statistics review, central limit theorem, hypothesis testing, analyzing the data, histograms, statistical process control, and more. 

Module 4 covers the following topics: 21CFR 211.22 Responsibilities of quality control unit, ISO9001:2008 (E) 8.5.2 Corrective Action, industry terms, root cause analysis, method comparison (Anderson and Fagerhaug, PDSA, Six Sigma, 7-Step, and 8-Disciplines (8D), Pareto Chart, Investigative Process, and more. 

For orientation purposes Module 1 - quality systems.pdf is included as a separate attachment and offers a sample of the type of material included in this collection. 

Below is a list of the files contained within the .zip attachment. The size of each file is included in parenthesis. 

Module pdfs (4 files, 11.2 MB)

• Module 1 - Quality Systems (Module 1 - quality systems.pdf 2 MB)
• Module 2 - Measurement and Sampling (Module 2 - measurement and inspection.pdf 2.6 MB)
• Module 3 - Analysis (Module 3 - analysis.pdf 2.7 MB)
• Module 4 - Business Processes (Module 4 - business practices.pdf 3.8 MB)