QUALITY SYSTEMS TRAINING OVERVIEW FAQs The Quality Systems Training Program is a short-term intensive noncredit training course to prepare students for jobs in Quality Assurance and Quality Control, for a variety of manufacturing industries including biopharmaceutical processing, medical device manufacturing and others. Am I a good fit for the Quality program? A Career Development Coach will meet with you one-on-one to discuss your interests and skill levels to determine whether or not the training is a good fit for you. COURSE CONTENT What is the cost? The training is free to qualified individuals. • • • • Concepts in Quality Professional Framework Quality Systems Measurement/Inspection • • • • Quality Operations Validation Root Cause/CAPA Lean Six Sigma CERTIFICATION • • Knowledge toward American Society for Quality (ASQ), Quality Improvement Associate (CQIA) or Quality Process Analyst (CQPA) Certification exams Aligns with MWCC Credit Coursework CAREER OPPORTUNITIES Students who successfully complete this training program will be prepared to seek positions requiring knowledge of regulated and international quality systems, continuous improvement techniques, and understanding of the tools used to have a positive impact on an employer’s bottom line. Quality Analyst; Quality Inspector; Regulatory Associate and Document Control Specialist 978-632-6600 | mwcc.edu AA/EEO Institution This program is sponsored by a $15.9 million grant from the U.S. Department of Labor, Employment and Training Administration. The AMMQC program is an Equal Opportunity program. Adaptive equipment is available upon request for individuals with disabilities. When will the next session begin? New classes begin every 8 weeks. How long is the training? The training runs for 2 weeks, Mon-Thurs from 8:30a2:00p Do I need to take an admission test? You will take the Work Keys Assessment, which is an adaptive assessment that will gauge your proficiency in reading, math and locating information. I currently receive unemployment benefits. How will this affect the process? You will want to speak with your Career Counselor to determine whether or not you are eligible for the Section 30/TOP program. Either way, you are still eligible to enroll in the training. Contact Us 978-630-9883 mwcc.edu/advancedmanufacturing Quality Systems Training This program is designed to provide skills necessary to become a Quality Assurance or Quality Control Associate employed by manufacturing companies in a variety of business sectors. The concepts and skills presented in this two week program are relevant to both production and service applications. Content Area Overview Module 1 Concepts in Quality Organizational Framework Professional Practices - Ethics 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. Module 2 Quality Systems Auditing Professional Practices - Confidentiality 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. Module 3 Measurements 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. Module 4 Inspection and Sampling Print Reading 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. Module 5 Analysis 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. Module 6 Quality Operations Professional Practices Teamwork Conflict Resolution Communication 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. Module 7 Root Cause Investigation CAPA Systems 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. Module 8 Validation 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. Module 9 Lean Six Sigma 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.