Quality 1 (Apprenticeship)
Description
This module will give an introduction to the concept of Quality. It will deal with the quality assurance systems, quality management principles, and quality tools and techniques used to ensure the production of quality products on a manufacturing line.
Learning Outcomes
Discuss and compare philosophies and new trends in quality management and their place in today's manufacturing and service environments including Total Quality Management (TQM).
Analyse and apply a range of statistical tools to measure quality. Select appropriate methodologies of quality improvement and apply various tools and techniques for analysis of quality.
Describe the functions of the GMP, EU and US authorities, departments, agencies and other bodies responsible for developing and implementing the laws and associated regulations for Quality and high-tech industry; and describe their Regulatory Requirements, which affect the development, manufacturing and quality of products, e.g. medical devices.
Review the procedures required to ensure that Documentation - for Operating Procedures and Process data, Product data and Quality data - is accurate, clear and concise, has correct revision control, is correctly stored, supports traceability, and complies with regulations.
Determine the classification of a medical device.
Decide if an adverse event should be reported and if so describe the correct reporting procedure.