Higher Certificate in Operations, Quality & Lean Management

Semester 1

• Problem Solving Tools and Techniques
• Applied Practice 2: Organisational Alignment
• Financial and Management Accounting

Semester 2

• Supply Chain Management
• Fundamentals in Regulatory Affairs
• Validation Principles and Practices

Module 1: Problem Solving Tools and Techniques 

Module Aim 

This course will provide participants with a solid foundation for defining Lean and Six Sigma projects and then launching the projects successfully. The course will show the student that all processes can be analysed and systematically improved on a continual basis. The course covers topics such as creating a SIPOC chart, creating a Value Stream Map and setting up data collection plans. It provides participants with problem-solving skills with a particular emphasis on the DMAIC (Define, Measure, Analyse, Improve and Control) model. 

Learning Outcomes 

1. Describe the role of Lean Six Sigma and discuss the role of a lean champion in support of Organisational goals utilising Lean Six Sigma Principles 
2. Explain the leading principles in the area of Lean Thinking and relate these principles to business practices and areas 
3. Apply problem-solving tools to a real world scenario 
4. Demonstrate a range of problem-solving skills with a particular emphasis on the DMAIC (Define, Measure, Analyse, Improve and Control) model 
5. Perform process Input/Output analysis and apply probability and statistical rules and concepts to improve processes. 
6. Apply Error Proofing methodology to a Case Study in an organisational setting.

Module 2: Supply Chain Management 

Module Aim 

To provide the students with the theoretical background and knowledge which will enable them to analyse Global Logistics & Supply Chain Management and to understand the elements which require integration in order to ensure the successful management of Logistics & Supply Chain organisation. To understand the major challenges and issues facing organisations developing and implementing supply chain strategies To enable the student to understand the contributions of a supply chain approach to organisational efficiency and effectiveness and to analyse the benefits that can accrue from implementing effective supply chain practices. 

Learning Outcomes 

1. Analyse the complexities of supply chain management as it applies to a variety of Logistics & Supply Chain businesses 
2. Assess the role played by technology and information technology in Supply Chain operations 
3. Analyse the linkage between the overall business aims and managing the strategic objectives of the supply chain 
4. Reflect on the practice and skills for effective individual and professional development 
5. Evaluate the processes involved in different supply chain management systems, with a particular focus upon total quality management. 
6. Explore sustainable practices in supply chain management systems.

Module 3: Financial and Management Accounting 

Module Aim 

The aim of the module is to provide students with an understanding of the financial accounting concepts, which will enable them to interpret financial statements for limited liability companies, and management accounting techniques used for the provision of information to mangers to assist with planning, control and decision-making. 

Learning Outcomes 

1. Outline the fundamentals of financial statements of limited companies. 
2. Critically Interpret the financial statements of limited companies using ratio analysis. 
3. Analyse and discuss the use of marginal costing for decision-making. 
4. Prepare cash budgets and operational budgets. 
5. Create spreadsheet models with an accounting/business focus for e.g. budgets 
6. Identify and appraise the key components of Cost-volume-profit analysis

Module 4: Applied Practice 2: Organisational Alignment 

Module Aim 

This module affords students the opportunity to implement the core work practice skills to compliment the other taught modules. Students will be required to make a business case proposal and it will form the basis of a work based learning project that will demonstrate the ability to engage as a skilled practitioner in their discipline. The aim of the module is to encourage learners to develop integrative learning, independent thought and critical reflection skills as they bring together a range of concepts, theories, frameworks and practices. 

Learning Outcomes 

1. Describe their role in an organisation, and that they can identify potential areas for improvement, with an awareness of the methodology required to deliver an internal project. 
2. Discuss the benefits of a SWOT analysis for your domain area of study. Develop an understanding of the business and industry environment of the modern workplace, identifying roles and potential impact while creating awareness of the necessity for continual organisational change. 
3. Conduct a SWOT and PESTLE analysis for an organisation, including departmental SWOT and PESTLE as necessary. 
4. Discuss how to conduct a Value Chain Analysis as applied to the organisation. 
5. Demonstrate the competence to conduct work and manage projects in a methodologically sound and ethical manner while giving due consideration to assisted business and project risks. 
6. Consolidate and extend independence, self-reliance, moral and ethical judgement in the context of professional decision making and leadership and communicate effectively using both verbal and written skills. Reflect on, analyse and document the learning experience resulting from applied practice.

Module 5: Fundamentals in Regulatory Affairs 

Module Aim 

The module will explore a range of regulatory standards such as ISO 9001:2015, ISO 13485:2016, ISO 16949:2016, ISO 14001:2015 along with EudraLex ,the CE Markings and the Machineries directive. This module will identify the role of the regulatory bodies FDA (US Food and Drug Administration), the EMA (the European Medicines Agency) and European Food Safety Authority. The module will introduce the student to an understanding of the importance of auditing in successfully managing a quality management system 

Learning Outcomes 

1. Analyse the importance of regulatory/compliance requirements for organisations. 
2. Interpret the role and the interaction of the FDA and the EudraLex in the biopharmaceutical industry 
3. Evaluate the requirements of a range of international regulatory/compliance standards as they apply to various manufacturing and service industry environments. 
4. Interpret the role that regulatory requirements have in regard to Continual Improvement. 
5. Interpret the role that Auditing and ISO 19011:2018 plays in the management of a Quality Management system 
6. Create an internal audit plan in compliance with regulatory requirements for either a Manufacturing, Food Safety, Medical Device, Service or Biopharma organisation.

Module 6: Validation Principles and Practices 

Module Aim 

This module covers the science and practice of validation and verification, as they apply within regulatory compliant environments, such as the pharmaceutical and medical device sectors. This module aims to ensure students understand the role of the validations function within an organisation and its role within Good Manufacturing Practice and other applications 

Learning Outcomes 

1. Display an ability to interpret the role of validation within Good Manufacturing Practice 
2. Develop a knowledge of the history of validation. 
3. Appraise and illustrate the differences between Validation and Verification 
4. Identify and evaluate the various validation guidelines in use. 
5. Prepare a validation document in accordance with regulatory guidelines. 
6. Interpret the approach to Process Validation – DQ, IP, OQ and PQ.

Mature applicants (over 23 years of age) that have acquired the Certificate in Operations, Quality and Lean Management Level 6 qualification or equivalent qualification, as per the TUS RPL Policy.

Two evenings per week 6.30pm – 9.30 pm (online) Plus selected Saturdays (online)

€2,500

One Year

Upon successful completion of this course, students are eligible to progress to the Bachelor of Science in Quality and Lean Management (Level 7) (One Year).