This module will provide a thorough introduction to management and focus on practical tools and techniques for effective supervision. It is intended to provide the student with the skills and techniques required to understand how to manage staff in a modern organisation.

1. Demonstrate an understanding of management and its evolution. Be able to describe a manager’s role and responsibilities.

2. Explain the skills and qualities of an effective manager.

3. Describe different types of interpersonal behaviour and how they impact management strategies.

4. Illustrate a number of tools and techniques for decision making and problem solving

This module is intended as an introductory course in Quality and Production Management and is complementary to Quality and Production Techniques 2. The role of the Production System including the Supply Chain and purchasing are introduced. The concept of Total Quality Management, Quality tools including basic Control Charts are addressed. Lean Management is also discussed.

1. Describe the production system and its various functions
2. Explain the roles, tasks and functions of production and quality management within the manufacturing environment.
3. Explain the role of the supply chain
4. Demonstrate the importance of quality within the manufacturing environment and use simple quality tools to analyse data.
5. Explain lean manufacturing

The Lean & OpEx module is primarily aimed at those working in a modern manufacturing or service environment who wish to expand their knowledge of the principles of Lean methodologies and Operational Excellence. We will also review the Shingo model for operational excellence.

Lean and OpEx have been embraced by leading global organisations in the manufacturing and service sectors and are now the foremost process improvement approach for organisations that wish to attain world-class performance in quality and customer satisfaction by eliminating 'waste' in their processes. In Lean terms, 'waste' refers to anything that does not add value to the product or service in the eyes of the customer.

The Lean tools are a key component and enabler of Operational Excellence where problem-solving, teamwork and leadership result in continuous improvement in the workplace. Although originating in manufacturing, the Lean tools and techniques are also being used in services such as healthcare, banking and government sectors where benefits have been achieved in productivity, efficiency, and cost reduction.

Participants are given free access to Minitab Workspace software during their course of study at ATU. Minitab Workspace contains powerful visual tools, process maps, brainstorming diagrams and forms in one intuitive interface that will be utilised throughout the course.

1. Describe the key principles of Lean and Operational Excellence (OpEx) and how they can be used to drive continuous improvement and competitive advantage in an organisation. e.g. Lean transformation, Strategy deployment.

2. Recognise the potential sources of waste in a process and identify the appropriate Lean tool(s) to measure and reduce/eliminate that waste. e.g. Leader Standard Work (LSW), Audits, Gemba waste elimination walks.

3. Demonstrate the application of typical Lean tools such as Value Stream Mapping, SMED, Error Proofing, 5S, Visual Management, TPM, Kaizen Events, in creating a continuous flow.

4. Identify and use the appropriate metrics and Key Performance Indicators (KPIs) to improve process performance in terms of quality, throughput, productivity and cost. e.g. Yield, Lead time, Cycle time, Downtime and Efficiency.

5. Demonstrate the use of problem-solving tools such as 5-Whys, Brainstorming, Cause & Effect (Fishbone) and A3 sheets in Root Cause Analysis (RCA).

This module explores the role of metrology in modern manufacturing and the management and control of measurement systems. It covers all aspects of measurement management from interpretation of specifications, determination of metrological and calibration requirements to evaluation and ongoing calibration and maintenance.

1. Specify suitable measurement instruments and standards.
2. Describe the International System of Units (SI), including the seven base units, and identify various national and international organisations that provide metrology references, resources and standards
3. Identify the essential components of metrology traceability

4. Describe and define measurement assurance philosophy

5. Explain the concepts of measurement and metrology

This module is designed to prepare the student for progression onto the degree level 7 Quality and Manufacturing Management programmes. It is intended to provide a broad approach and foundation for mathematics required by Quality Students at L7 and L8. The main topics are: Algebra Statistics Graphs Volumes and Areas Trigonometry Integration Differential Calculus This module makes use of real life situations where the techniques are used. The online students are already working in industry and can see where engineers make use of the techniques.

1. Present Statistical Information and be able to undertake statistical analysis of raw data.

2. Perform basic differentiation and integration functions.
3. Work out volumes and areas of regular and irregular shapes.
4. Solve problems and perform calculations on compound interest and depreciation.
5. Solve problems involving finite and infinite geometric and arithmetic series.
6. Perform graphical analysis.

7. Apply Trigonometry to practical situations.

This module is a work-based learning module where students complete a number of learning tasks based on a pre-approved learning plan. On completion of the module, students should have acquired the basic skills required to contribute to process improvement in their company.

1. Assist the EH&S department to improve health & safety and sustainability procedures.
2. Work with supervisor to analyse standard operating procedures, report on gaps and propose needed improvements.
3. Set-up and complete manufacturing process operations independently.
4. Interpret quality assurance reports and identify common causes of defects.
5. Work with the quality department to update methods.
6. Take part in Lean 6 Sigma projects and implement changes.
7. Work as part of a team and perform individual tasks respecting deadlines.
8. Explain the improvements made to the manufacturing equipment and associated SOPs used.
9. Use a spreadsheet software programmes to graphically represent data, compare processes and communicate findings.
10. Reflect on their learning and identify gaps.

Topics covered in this module include an orientation to GMP, EU and US regulations, documentation requirements, conducting investigations, CAPA, auditing, QC (quality control) laboratory operations and management responsibilities. Upon completion, students will be able to apply these GMP practices in regulated industries.

1. Demonstrate a basic grounding in the fundamentals of GMP, its regulatory basis and the critical role these GMP practices play in ensuring that pharmaceutical products and medical devices are consistently safe and effective, and are produced to high quality standard.
2. Describe the roles of QA and QC within a Quality Management system and their location within the process flow. Communicate examples of QA/QC responsibilities relevant to various processes.
3. Describe the roles of all personnel, training, engineering, maintenance, production and contractors within a GMP organisation.
4. Explain and illustrate the concepts of proper documentation utilized in a GMP environment and its function in traceability investigations and formal contracts.
5. Participate in the use of the tools and methodologies that provide an approach for developing corrective and preventive actions that address and limit manufacturing failures.
6. Describe key principles that ensure the validity of all data generated within a GMP environment.

This module introduces the student to the area of validation. The student will learn the reasons behind the stringent validation requirements in the pharmaceutical, biopharmaceutical and medical device sectors. The student will become familiar with the actual regulatory requirements for validation activities and understand the expectations from both an EU and US regulatory point of view.

1. Comprehend and discuss the reasons for strict regulatory requirements in relation to validation.
2. Discuss process validation requirements and the lifecycle approach.
3. Interpret the requirements of the European Union Good Manufacturing Practice (GMP) guideline for qualification and validation in pharmaceutical/biopharma and/or medical device manufacturing settings.
4. Describe the different stages of a validation project and what happens at each stage, including the various validation categories.
5. Interpret the different requirements which are necessary for a User Requirement Specification and how this links to the success of a validation project.

Instrumentation 1 is a foundation course in the principles of electronic circuit theory and the fundamental technologies & practical applications of sensors. The module aim is to equip learners with the basic theoretical and practical skills required to analyse and test low voltage direct current electrical circuits. It addresses topics such as Ohm's Law, Kirchoff's Laws, voltage, capacitance, inductance, semiconductors and the sensing of common parameters for system monitoring and control including temperature, pressure, light, and distance.

The ambition of the module is to equip the learner with the necessary knowledge and skills for further studies in electronics, mechatronics, and instrumentation.

1. Explain the basic atomic structure and associated electrical properties of conductors, insulators and semiconductors
2. Define and use common electrical units, laws and relationships and perform calculations of component values
3. Perform basic circuit analysis including calculations of relevant component values and electrical quantities.
4. Describe electrical characteristics and applications of specified semiconductor devices, including diodes, sensors and actuators
5. Perform appropriate measurements on circuits using voltmeters, ammeters and ohmmeters and to record and analyse the results in reports.

On completion of this module, the learner can expect to be proficient in the fundamental aspects of programming from both a theory and practical perspective. The learner can expect to be able to design and write short programs to solve straightforward and clearly defined engineering based problems. The concept of testing programs is introduced,

This module assumes no prior knowledge of programming.

1. Recognise, differenciate and use the structural (code) aspects of a program in various programming solutions
2. Recognise and select appropriate data (content) structures for various programming solutions
3. Demonstrate proficiency in programming using input/output variables, making decisions (if/else), use of loops and functions in various programming solutions.
4. Demonstrate proficiency with compiling, debugging and modifying simple programs of modular design using basic input/output techniques.
5. Identify suitable test data to test written programs and to assess the outcome of results of tests executed.

This module will give the students an introduction to pneumatic/electro pneumatic and hydraulic systems.It will cover basic pneumatic and hydraulic components and their use in complete systems. The student will also become acquainted with standard pneumatic and hydraulic symbols in accordance with IEC standards and be able to use a software simulation package to draw and simulate practical circuits.

This module will also cover advanced pneumatic and electro pneumatic circuits including sequencing of pneumatic cylinders. The circuits will be build and simulated in software.

1. Describe the components of a compressed air and air treatment system.

2. Demonstrate an understanding of pneumatic circuit operation, including sequence control.

3. Apply the cascade method to solve pneumatic sequential problems involving cascade groups and cylinders.

4. Design and simulate electro-pneumatic circuits to sequence cylinders.

5. Employ formulae to calculate flow rate, piston force, system pressure and piston size.

The student will learn to define the standard units of measurement, forces, power, and work. The student will add forces, determine forces due to friction, use moment of forces and the principle of moments to solve for forces in beams. The student will calculate the components of forces. The student will calculate the position of the centre of gravity and centroid of area for various shapes. The student will learn the relationship between stress, strain and Young's modulus and use the relationship and factor of safety to solve simple design problems. The student will also learn how to use the linear and angular laws of motion.

This module is jointly taught by a number of lecturers and includes many examples of how mechanics is used in real life situations

1. Define and manipulate the standard units of measurement used in mechanics, and explain the relationship between mass, weight and force, and explain the concepts of work, power and efficiancy
2. Manipulate, addition, resolution into components, of vectors to solve problems in statics, and involving friction.
3. Use moments of forces and the principle of moments to solve problems involving non-concurrent forces, and frameworks.
4. Use the definition of stress, strain, Young’s Modulus, and factors of safety to solve problems involving the strength of components and composite bars
5. Use the linear laws of motion to convert to angular motion and solve problems associated with rotation of shafts.

This module provides the candidates with the skills and knowledge of current standards in Engineering Drawing and Computer Aided Design. The candidates will be capable of generating 3D solid models of engineering related components and assemblies within a commercially available CAD package and will have the necessary skills to communicate effectively with society and other professional engineers. Students will be introduced to a range of modelling features and apply them in the design and modelling of such components.

1. Demonstrate the ability to sketch and illustrate engineering components.
2. Demonstrate the necessary knowledge and skills to interpret engineering drawings.

3. Use a solid modelling CAD system to create 3D models of parts and assemblies for common engineering devices found in the manufacturing industry.

4. Produce detailed part and assembly drawings of engineering parts, products and devices, in an efficient and conventional manner.

5. Apply CAD concepts and skills to communicate design intent for a single manufacturing related device, consisting of a number of parts.

This module will provide a thorough introduction to management and focus on practical tools and techniques for effective supervision. It is intended to provide the student with the skills and techniques required to manage staff in a modern organisation.

1. Illustrate a number of tools and techniques for decision making and problem solving

2. Describe the benefits of teamwork and how to motivate staff. Demonstrate an understanding of leadership.
3. Explain appropriate interview skills for various situations.
4. Provide an overview of Industrial Relations, Employment Law and Health and Safety requirements.

This module is intended as an introductory course in Quality and Production Management and is follow-on to 'Quality and Production Techniques 1'. The day-to-day management of a production system including capacity management, layout planning and design, inventory management, operations and material planning are addressed.

1. Describe the different types of production/operations systems.
2. Explain capacity planning and inventory management
3. Demonstrate the importance of MRP systems

4. Solve simple prodution management problems

This module builds on the knowledge gained in validation principles. This module explains how validation activities are undertaken from a practical point of view. It covers Cleanroom and Cleaning validation, analytical method validation and includes an introduction to computer systems validation and sterilisation validation.

1. Define how validation principles are applied to actual validation projects.
2. Actively participate in completing validation projects in many different sectors such as pharma/ biopharma and medical devices- validation activities including cleanroom validation, cleaning validation, computer systems validation and sterilisation validation.
3. Explain the sequence of events necessary for a successful validation project.
4. Evaluate the importance of cleaning to the organisation and discuss how a cleaning validation project can be undertaken.
5. Demonstrate an understanding of analytical method validation and what factors must be considered when validating an analytical method.

This module aims to provide students with an introductory knowledge and understanding of legislation and Regulatory affairs in EU and US with a particular focus on Biopharmaceuticals and Biologics

1. Demonstrate they have a knowledge and understanding of the main regulatory institutions in the EU, USA, and Rest of World and their workings
2. Demonstrate they have a knowledge and understanding of the ICH and regulatory harmonisations.
3. Demonstrate an understanding of the Drug development/Clinical Trial Process with the and how it interacts with the Drug approval process for both Europe and USA.
4. Demonstrate an understanding of the various principles and practices involved in the control and regulation of the medical device industry both in Europe and the USA
5. Demonstrate a knowledge of the different roles and responsibilities to ensure legal marketing, manufacture, distribution and sale of drugs.

Instrumentation 2 builds on the core electronic circuit theory and sensor principles gained from the Instrumentation 1 module. It starts by introducing the learner to the concept of networks and the effects of loading. The module also considers the important specifications of sensors and gives an overview of basic control theory. 555 timers and signal conditioning such as transistor circuits, amplifier circuits, A/D and D/A conversion are also are analysed.

The ambition of the Instrumentation modules is to equip the learner with the necessary knowledge and skills for further studies in electronics, mechatronics, and instrumentation.

1. Describe the concept of measurement and control systems, explain associated terminology, and perform calculations on actual systems

2. Design interfacing circuits to switch/drive a DC load, using a transistor
3. Design signal conditioning circuits involving op-amps
4. Design timer circuits to provide timing pulses and delays, in mechatronics systems
5. Use sensors, in addition to signal conditioning circuits to perform measurements.

On completion, the learner will be able to design and implement a program-based control unit which will make decisions based on sensor input to drive actuators, e.g. Control unit detects temperature rise and display on an LCD. The module encourages self-directed learning and hardware development in the learner's own environment. An Arduino kit is needed for this module (K000007 Official Arduino Kit).

The learner will be exposed to small signal interfacing, controlling actuators such as different types of motors, using an LCD display, Internet communications between devices and data transmission.

1. Recall numbering systems (decimal, binary, hexadecimal) and to convert between them
2. Develop data transmission programs based on a set of characters

3. Develop programs to control actuators based on interfacing via analog and digital methods to prescribed sensors using a variety of methods such as analog to digital conversion and pulse width modulation.

4. Describe how IP packets are transmitted on the internet and outline the main elements of a network and the meaning of the IP packet header attributes.
5. Interface application programs to a given API with the corresponding documentation to implement automation solutions (e.g Arduino API to control actuators based on sensor information)

In this module students will be introduced to the concept of PLCs and their implementation in automation systems. Students will learn how to program brick type and modular PLCs and learn PLC relevant concepts of signal processing.

1. Apply sequential function chart (aka Grafcet or state-transition) methods to control sequential processes including selective and parallel branching techniques.
2. Use simple programming instructions to include the use of applied instructions and register use.

3. Produce ladder logic to solve electro-pneumatic sequential problems involving the use of two cylinders.

4. Employ specific addressing configuration of an industry standard PLC and apply same to practical automation problems.

5. Create ladder logic to solve industrial problems using timers, counters and flip flops.

The student will determine stress in materials used in compound bars. The student will perform calcualtions involving shear stress, shear strain, and poisson's ratio. The student will draw shear force and bending moment diagrams. The student will calculate stress in thin walled pressure vessels, and thin rotating rings. The student will make calculations involving torsion. The student will do calculations involving thermal strain..

This module is jointly taught by a number of lecturers and includes many examples of how mechanics is used in real life situations

1. Calculate stresses in each material of a compound bar.
2. Manipulate and perform calculations involving shear stress, shear strain, and poisson’s ratio.
3. Perform calculations invollving stress in thin walled pressure vessels and thin rotating rings.
4. Manipulate the formula involving torsion to determine safe loads.
5. Determine and draw bending moment and shear force diagrams for various beams.

This module is a work-based learning module where students complete a number of learning tasks based on a pre-approved learning plan. On completion of the module, students should have acquired the basic skills required to contribute to manage a process in their company and mentor newly appointed staff.

1. Take responsibility for H&S and sustainability procedures in their own area.
2. Manage standard operating procedures, report on gaps and propose needed improvements.
3. Set-up, troubleshoot and operate equipment independently.
4. Work with the quality department to handle SCAR and develop a CAPA.
5. Lead a yellow belt project and implement changes.
6. Develop a plan to achieve outcomes of a yellow belt project within deadline.
7. Teach processes to newer operators and monitor progress.
8. Detail the methodology followed to achieve a specific improvement of a manufacturing process.
9. Use a spreadsheet software programme to process data.
10. Present the outcome of a project to stakeholders.
11. Reflect on their learning, identify gaps and propose a strategy for improvement.
12. Lead a team to achieve defined outcomes.