Strategic Quality Managment

Why was this course developed?

The Certificate in Strategic Quality Management was developed based on an analysis of the importance of the pharmaceutical and related industries in Ireland and within the South-East region and also using information generated from the Wales Ireland Network for Scientific Skills (WINSS) Scientific Survey from a large number of pharmaceutical/biotechnology, medical device and food companies. More than 70% of the companies surveyed identified transferable skills as the major skills deficit, with high demand for training in areas such as data management and creative problem solving skills, as well as quality management. These companies identified skills shortages in the following quality management areas: six sigma, lean manufacturing, risk management, validation, change management, continuous improvement etc. Recognising this demand, the Certificate in Strategic Quality Management was devised to address this skills deficit.

This course was developed to provide the student with an advanced understanding of the theory, practices and implementation issues associated with advanced quality methodologies such as Leadership, Six Sigma and Lean Manufacturing. It will provide the student with the skills necessary to evaluate how lean, Six Sigma and risk management principles can be used to guide lean implementation, and to identify the key factors for effective motivation of staff applying these lean tools and techniques. The course will also develop the student's competence in a range of technical and management quality tools, and demonstrate how these can be applied in an industrial environment. 

Competitive advantage. project management and managing change are key components of applying strategic quality management principles in an industrial setting, and these will be covered in detail. Critical thinking, problem solving and decision making will be key components of this learning. The student will also learn to critically evaluate the importance and practices of analytical method transfer and equipment validation activities, including automated and computer systems, and how to develop a systematic approach to validation experimentation. This will include evaluation of the effect that routine laboratory operations have on the quality of the final product. 

What are the learning outcomes?

On successful completion of this module, a student will be able to:

• Evaluate how lean, six sigma and risk management principles can be used to guide lean implementation. 

• Synthesise the key factors for effective motivation of staff applying lean tools and techniques.

• Justify critical thinking, problem-solving and decision making, project management and the management of change in an industrial environment.

• Critically evaluate the effect that routine laboratory operations have on the quality of the final product.

• Ascertain the principles and practices of analytical method and equipment validation and summarise a systematic approach to validation experimentation.

• Critically evaluate the importance and practices of validation activities, documentation and analytical method transfer, including automated and computer systems.