Bachelor of Science in Quality Management (QM)

Overview

There is no room for error in the manufacturing environment. Employee safety and company reputation are on the line, and effective quality systems and practices must be in place and followed every day to maximize productivity and effectiveness. This dynamic, high-stakes environment needs professionals who are trained in quality management to help ensure excellence in all critical processes.

Grace College’s GOAL (Grace Opportunities for Adult Learners) program is created just for students balancing work and personal commitments while pursuing an education. Our online Bachelor of Science in Quality Management program offers convenient scheduling and academic resources to make completing a bachelor’s degree a reality. Building upon previous college credits and life-long learning experiences equivalent to about two years of college, the GOAL degree can be completed in 16 months.

The Bachelor of Science in Quality Management program at Grace College is designed to prepare adults with the knowledge and skills to pursue careers in the manufacturing industry. The program focuses on the critical elements in quality management, including quality systems, post-market surveillance, design control and assurance, manufacturing quality and supply chain management, and statistical processes. The highly-trained instructors at Grace College will give you all the tools you need to enter this rewarding and challenging career field.

If you would like to visit campus or have any other questions, please do not hesitate to contact us.

Phone: 877-607-0012
Email: goal@grace.edu

Courses

Quality Systems (QMD 3000)

Content areas in this course will include:

  • Quality concepts
  • Management responsibility
  • Quality policy
  • The cost of quality
  • Survey of the regulations: FDA QSR, global regulations, pre-market submissions, 510(k), PMA, CE mark, medical device law
  • Review of all quality system elements (quality system requirements; design controls; document controls; purchasing controls; identification and traceability; production and process controls; acceptance activities; non-conforming product; CAPA; labeling and packaging controls; handling, storage, distribution, installation and records; servicing; and statistical techniques)
  • Quality systems interactions and interdependencies (integrated quality management), implementation, and compliance with FDA QSR (CFR21 part 820), ISO, and other regulatory and notified body regulations
  • Audit: QSIT, supplier audit, internal audit, program and schedule development, audit readiness, audit process management, addressing audit findings, audit reports, audit questions
  • Managing regulatory compliance inspections/audits (FDA, notified bodies, etc.)
  • Document controls: document control ANSI/AAMI/ISO standards and compliance, records management (records retention, device master record, device history record, quality system records), complaint files, training requirements

Survey in Statistics (QMD 3400)

Content areas in this course will include:

  • Probability and statistics
  • Data analysis
  • Statistical process control
  • Statistical tools for six sigma: charts, controls and diagrams
  • Design of experiments: establishing, controlling and verifying process capability and product characteristics

Design Control and Assurance (QMD 3200)

Content areas in this course will include:

  • Research and development processes (phase gate, etc.), new product development, design control requirements—FDA and MDD
  • Design inputs and outputs, design review, design transfer and changes, design history files
  • Validation and verification
  • Mistake-proofing, failure modes and effects analysis for design
  • SWOT analysis
  • Avoidance of overly burdensome processes
  • Human factors and competency requirements 
  • Design for manufacturability and reliability
  • Project planning

Manufacturing Quality and Supply Chain Management (QMD 3300)

Content areas in this course will include:

  • CGMP (device master record, production and process controls and changes, packaging, labeling, storing, distribution, etc.)
  • Failure modes and effects analysis for process, inspection, verification and validation (for both process and software), metrology, clean and sterile requirements
  • Statistical process control
  • Non-conforming product, identification and traceability of product, environmental control, manufacturing material removal, calibration, acceptance activities
  • Calculating cost of quality, quality programs and initiatives, strategies for cost improvement, relationship between quality improvements and financial performance, lean principles and processes, introduction to six sigma, metrics, performance optimization
  • Diagnosing and solving problems in real time
  • Supplier selection, supplier quality, supplier controls, raw material quality control, customer supplier partnership management, supplier non-conformances, supplier certification
  • Purchasing controls

Post Market Surveillance (QMD 3100)

Content areas in this course will include:

  • Complaints and complaint handling
  • Reporting to regulatory bodies (FDA, global)
  • MDR reporting
  • Corrections and recalls, developing and deploying an action plan, market withdrawals
  • CAPA—elements of effective CAPA, verification and validation of CAPA, CAPA effectiveness, documenting CAPA
  • Post market clinical data, retrospective analysis, trending and tracking, trending tools, signal detection informing appropriate action, risk assessment
  • Health hazard assessments
  • Adverse event investigations
  • Trend investigations, root cause analysis
  • Proactively surveying of customers (proactive versus reactive), customer loyalty surveillance

 

*NOTE: MDQM Certificate (1000 series) requires all five classes. A Bachelor's in Quality Management (3000 series) requires all classes plus the Bachelor in Management degree core (GOAL curriculum). Bachelor’s students can elect which five GOAL classes will be replaced by QM classes. A Master’s in Quality Management (5000 series) requires six QM classes (with an additional level of work per class) plus ORCA core (four classes) and two regulatory classes from the ORCA curriculum.