The primary outcome of this Project is the development of a set of modular curriculum that introduces and builds upon content addressing Quality Systems.  The result is a series of training and education programs that provide career pathways for individuals in a variety of industries including biopharmaceutical processing and advanced manufacturing.  The products were developed to address employer-identified skills gaps and provide multiple entry and exit points for students.  All curriculum was developed with specific Student Learning Outcomes incorporated and aligned with pathways to certification and/or college credit.  Mount Wachusett Community College continues use of the curriculum through ongoing programs, sharing with other institutions and expanded it in partnership with three other community colleges in Massachusetts.  The project also provided access to the curriculum to secondary school students through dual enrollment and outreach activities.

            The first level of curriculum was developed as part of a pre-employment / college bridge program entitled Industry Readiness Training.  The content comprised 12 hours of Quality Systems in 4 modules and 8 hours of Measurement Tools in 3 modules.  The content provides an introduction to Quality and Measurement.  Student knowledge was measured through pre- and post-testing and the Quality and Measurement portion of the Manufacturing Skills Standard Council Certified Production Technician Training.  Student Learning Outcomes for this content include:

 •          Explain how a quality system is implemented.

•           Recognize and apply good documentation practices.

•           Explain the cost-of-quality.

•           Describe how inspection processes are used.

            The second level of curriculum is a 40-hour Quality Systems Training program.  Students completing this program are prepared to sit for the American Society for Quality Certified Quality Improvement Associate examination and the Challenge Exam for AQS 115 (described below).  Students successfully completing this program will be able to:

•           Recognize and distinguish ISO 9001:2015 and FDA 21CFR Quality Management Systems.

•           Recognize and distinguish the roles and responsibilities of Quality Assurance and Quality Control personnel in organizations.

•           Understand and describe auditing principles.

•           Identify and apply sampling methods, inspection measurement and test equipment as quality control techniques.

•           Understand and describe metrology and calibration concepts.

•           Recognize and understand how basic quality tools are used for continuous improvement.

            The third level of curriculum includes the creation of credit coursework and the establishment of a one year credit certificate (Analytical Laboratory and Quality Systems; 29 credits) and an Associate degree (Biotechnology/Biomanufacturing Quality; 61 credits).   These programs include newly developed courses whose learning objectives are presented below.

AQS110 Introduction to Metrology     Students learn the fundamentals of Metrology including procedures and processes to control and evaluate quality. Includes measurements and associated error/uncertainty, calibration, statistical process control tools, lean six sigma practices and quality assurance/control concepts.

AQS115 Quality Systems and Auditing Principles     Students learn the components of a quality system.  The ISO library of standards and auditing principles is explored. Students learn to identify standards and demonstrate their knowledge using auditing tools. Students learn about the formal audit cycle: scope, preparation, performing the audit, reporting and follow-up actions.

AQS200 Root Cause Analysis                       Students learn problem solving methods used in industry to investigate and correct issues faced in a real-world setting. The student will apply the tools, analyze the data and evaluate the results to demonstrate an understanding of root cause analysis.  This course serves as a capstone class for the Associate degree.

CHE180          Instrumental Analysis             This course provides an introduction to the use of instruments a Laboratory Quality Technician will encounter. The fundamentals of using instrumentation to measure chemical properties and concentrations is covered, including sample preparation, calibration, and data analysis. The lab portion provides hands-on experience with a variety of different analytical chemistry techniques and instruments, as well as physical measurements.

            The final set of curriculum developed comprises two short term non-credit trainings for employees looking to expand their skill set.  This was done in partnership with an area employer, Masy Bioservices.  The focus of these trainings were Calibration and Validation and each were presented as a 10-hour, 4 class format.

            In addition to curriculum development, a major objective of the Project connected prospective students with career pathways in the area of Quality Systems, especially those from diverse backgrounds.  The AQS110 Introduction to Metrology course was provided to students from Worcester Technical High School, an urban school with a diverse student base.  Students received coursework at their school as well as coming to the Mount Wachusett campus for laboratory exercises.  In addition to this effort, numerous outreach events were held both at the MWCC Devens campus and throughout the college service area.  This included Career EXPO events attended by high school students where Quality professionals described their work, as well as company tours and classroom demonstrations.

Last Modified: 11/21/2017
Modified by: John Henshaw