Quality and Lean Management – Bachelor of Science (Ordinary) (L7, 60 ECTS)

Modules 

Semester 1 

Lean Project Management 

Calibration Services and Preventative Maintenance 

Standards and Regulatory Policies and Implementation 

Semester 2 

Reliability Engineering and Risk Management 

Applied Practice 4: Capstone 20ECTS 

Module 1:   Lean Project Management 

Module Aim 

This module introduces the fundamentals of project management and the steps involved in managing a project from concept to completion using Lean thinking as a fundamental concept. The module enforces the importance of adequate planning in order to prepare a thorough baseline to manage and control the project with an emphasis on ethics and social responsibility throughout this process. The module will also aid the student’s transition to working in an organisation by providing knowledge of organisation behaviour. 

Learning Outcomes 

1. Summarise the requirements of a project and reduce them to a set of manageable tasks.
2. Demonstrate an ability to plan the different stages of a project incorporating the requirements of time, cost, quality, risk in a sustainable manner 
3. Demonstrate project management tools and techniques to prepare schedules, cost analyses and reports through the use of computerized project management systems 
4. Evaluate the performance of a project in terms of cost and time 
5. Appraise the social, ethical and environmental responsibilities associated with individual projects 
6. Critique and define a projects’ status to it stakeholders

Module 2: Calibration Services and Preventative Maintenance 

Module Aim 

This module introduces the student to calibration and preventative maintenance requirements in a GMP environment. This module will ensure the students understand the calibration regulations, procedures and terminology and preventative maintenance requirements that are essential in a modern business environment. 

Learning Outcomes 

1. Discuss and illustrate best practice in equipment maintenance, equipment spares and materials. 
2. Debate the importance of Total Productive Maintenance, Lean Maintenance and Maintenance for Sustainability. 
3. Appraise Overall Equipment Effectiveness metrics and apply to recognised benchmarks. 
4. Apply calibration terminology in relation to measuring/analytical instruments. 
5. Design a calibration protocol for a piece of measuring and/or analytical equipment. 
6. Appraise the importance of calibration in a GMP environment

Module 3:  Standards and Regulatory Policies and Implementation 

Module Aim 

The module will explore the application of standards such as ISO, EudraLex legislation, CE Marking, the Machineries directive, the EMC directives as they apply to individual manufacturing operations. This module will identify the role of the regulatory bodies FDA (US Food and Drug Administration), the EMA (the European Medicines Agency), European Food Safety Authority, and give the student the ability to identify the regulators which have required compliance. 

Learning Outcomes 

1. Appraise the importance of the role that a Quality Management System has in an organisation. 
2. Preparing a QMS/Organisation for an external or third-party audit. 
3. Debate the role that leadership has in a quality orientated organisation. 
4. Appraise the role of GMP from initial drug trials to commercial product launch and subsequent pharmacovigilance market surveillance. 
5. Critically evaluate the requirements of the international standards ISO 9001:2015, ISO 13485:2016, ISO 14001:2015 and ISO 45001:2018 as they apply to various manufacturing and service environments. 
6. Appraise the challenges to Quality Management in the present and near future.

Module 4: Reliability Engineering and Risk Management 

Module Aim 

The aim of this module is equip the student with the concepts and purposes of Risk Management in todays world. The module will also look at the importance of Reliability Engineering with regards to meeting customers’ and organisations’ expectations. 

Learning Outcomes 

1. Demonstrate an understanding of Qualitative and Quantitative risk analysis methods. 
2. Apply the concepts of Reliability Engineering to determine and extend the useful life of products. 
3. Assess specialised methods and techniques for modelling and managing risk. 
4. Critically discuss the importance of risk in relation to relevant ISO Standards. 
5. Evaluate the contemporary and emerging trends and technologies in Reliability Engineering and Risk Management 
6. Assess the applicable Regulatory Standards for Risk Management across a range of industries and service environments.

Module 5: Applied Practice 4: Capstone 20ECTS 

Module Aim 

This module is designed to enhance the student’s understanding and the capacity to evaluate critically the theory of strategic management with particular focus on their quality function and the challenges facing senior management in formulating a quality management strategy. The nature and complexity of the business environment will provide the framework for the development of skills and competencies to facilitate an analysis of resources and strategic capability across the organisation. Through case studies, group discussions and evaluative exercises, participants will learn how to appraise and select strategic options in relation to an organisation’s quality standards, vision, structure and goals. The module also provides coverage of particular problems inherent in strategy implementation for the quality function, change management, and managing quality across departments. 

Learning Outcomes 

1. Identify and troubleshoot an existing or potential problem within their own organisation applying Lean Six Sigma project methodologies. 
2. Critique the strategic formulation process including strategic analysis, choice and implementation. 
3. Demonstrate project management strategies to investigate and implement appropriate methods to solve a work based learning project brief. 
4. Develop problem-solving and practical skills by undertaking an individual research project. 
5. Prepare a project report according to departmental guidelines and present the findings by means of an oral presentation

Students must have completed the Higher Certificate in Operations, Quality and Lean Management (Level 6) or equivalent or Recognition of Prior Learning (APL/APEL)

2-3 evenings per week 6pm to 9pm (online) Plus selected Saturdays per 9am – 1pm (online)

€2,500

This programme is funded under the Part Time Fee Scheme (SUSI) for Selected Undergraduate Programmes.

For more information on this scheme see https://www.irishstatutebook.ie/eli/2024/si/370/made/en/pdf

This is a Government Funded Programme. 

This programme is only open to successful applicants for SUSI funding for this particular programme 

Students will be required to pay a deposit of €500 on registration, which will  be returned to the student on approval of SUSI funding for the student and the student’s active engagement during the first  four(4) weeks of the programme. 

For more information on funding and how to apply see https://www.susi.ie/funding-for-part-time-undergraduate-courses/

One Year

Successful graduates of this programme are eligible to apply for the Bachelor of Science (Honours) in Quality and Lean Management (Level 8 Add On)  (Part-time, Online)