General Details

Full Title
Transcript Title
N/A %
Subject Area
MGMT - Management
LIFE - Life Sciences
08 - NFQ Level 8
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Tom Patton, Ailish Breen
Programme Membership
SG_SPHAR_H08 201900 Bachelor of Science (Honours) in Pharmaceutical Science SG_SPHAR_K08 201900 Bachelor of Science (Honours) in Science in Pharmaceutical Science

Pharmaceutical Operations Excellence details the philosophy, continuous improvement methods, systems and tools used in management of products, processes, services and supply chains to achieve excellence.

It considers business and operations strategy to inform decision making in planning, control and improvement, taking in lean thinking, six sigma and total quality management.  Tactical issues include plant layout and structure, project management methods, production scheduling and control, inventory management, quality control and inspection, equipment utilisation and maintenance policies.

Learning Outcomes

On completion of this module the learner will/should be able to;


Describe the strategic importance of operations and how it relates to other business functions; evaluate performance objectives, product life cycle and the volume and variety effect and how these impact strategic decision making.


Demonstrate an awareness of the philosophy of operations excellence; analyse continuous improvement tools and datasets such as JIT, Lean, six sigma, statistical process control, FMEA and evaluate appropriate methodologies.


Demonstrate an understanding of the concepts and methods related to designing and managing a pharmaceutical operations facility including job design, process and product design, supply network design and formulate designs for process flow and supply network location.


Appraise methods for planning and control in terms of supply chain, inventory and capacity management, scheduling and forecasting, and environmental factors.


Describe and evaluate the different Management Information Systems used in the pharmaceutical industry and examine emerging information, material and customer processing technologies.

Teaching and Learning Strategies

Classroom lectures will be given using a blend of teaching resources such as powerpoint, videos, flipchart activities and group work.  Some lean six sigma acitivites will be performed in a workshop style format.  Online resources will be used where appropriate.

Module Assessment Strategies

The module will be assessed using a blend of quizzes, individual / group assignments and final exam.  Assignments may be practical based and may require analysis of data.

Repeat Assessments

Repeat assignments will be given as required

Module Dependencies


Indicative Syllabus

A. Strategy

What is business and operations strategy and the changing nature of pharmaceuticals operations strategy.  What does Operations Excellence mean and how can companies achieve this competitiveness.  How performance objectives should interact with product life cycles, the volume and variety of products produced and inform design activities and operations decisions.  The role of Operations in achieving social responsibility.

B. Continuous improvement

What is means to be Lean / JIT and an evaluation of Lean tools (e.g. 5S, VSM, SIPOC), evaluation of the DMAIC process and analysis of six sigma tools (e.g Pareto, scatter plots), analysis of statistical process control and control charts (Cp, Cpk calculation), application of FMEA, failure analysis tools and examination of what is TQM.

C. Design

What is job design, process design, product design and key issues the operations manager faces at each stage of the design process.  Application of design tools, such as flow diagrams, cycle and takt time weighted score diagrams etc for analysing process flow and supply network design.

D. Planning and Control

Evaluation of tools involved in planning and control such as scheduling, forecasting, inventory and capacity management and environmental management.

E. Technology

What is industry 4.0 and how does this influence operations.  Evaluation of MIS tools used in the pharmaceutical sector for planning and control.  Evaluation of technology choices available in terms of degree of automation, scale and connectivity; new emerging technologies such as cloud based ERP, big data, internet of things.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
40 %
End of Semester / Year Formal Exam
60 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Assignment Short Answer Questions Continuous Assessment Assignment 20 % Week 8 2,3
2 Multiple Choice Continuous Assessment Multiple Choice 20 % OnGoing 1,4,5

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 End of term exam. Final Exam UNKNOWN 60 % End of Term 1,2,3,4,5

Full Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Not Specified Lecture 3 Weekly 3.00
Independent Learning UNKNOWN Self Study 4 Weekly 4.00
Total Full Time Average Weekly Learner Contact Time 3.00 Hours

Required & Recommended Book List

Required Reading
2013-07 Operations Management Prentice Hall
ISBN 0273776290 ISBN-13 9780273776291

This package includes a physical copy of Operations Management, 7e as well as access to the eText and MyOMLab. Operations management is important, exciting, challenging and everywhere you look! Important, because it enables organisations to provide services and products that we all need Exciting, because it is central to constant changes in customer preference, networks of supply and demand, and developments in technology Challenging, because solutions must be must be financially sound, resource- efficient, as well as environmentally and socially responsible And everywhere, because in our daily lives, whether at work or at home, we all experience and manage processes and operations. Operations Management focuses on the sustainable and socially responsible imperatives of operations management, using over 120 cases and illustrations of real-life operations around the world, including Apple, Medecins Sans Frontieres, Amazon, Ecover, Dyson, Disneyland Paris, Google, The North Face, and many more. Join over 10 million students benefiting from Pearson MyLabs. This package comes with MyOMLab, an online homework and tutorial system designed to test and build your understanding. MyOMLab provides a personalised approach, with instant feedback and numerous additional resources to support your learning. A student access code card may have been included with this textbook at a reduced cost.If you do not have an access code, you can buy access to MyOMLab and the eText anonline version of the book - online at"

Required Reading
2002-04-25 Lean Six Sigma McGraw-Hill
ISBN 0071385215 ISBN-13 9780071385213

Time and quality are the two most important metrics in improving any company's production and profit performance. Lean Six Sigma explains how to impact your company's performance in each, by combining the strength oftoday's two most important initiatives--Lean Production and Six Sigma--into one integrated program. The first book to provide a step-by-step roadmap for profiting from the best elements of Lean and Six Sigma, this breakthrough volume will show you how to: * Achieve major cost and lead time reductions this year * Compress order-to-delivery cycle times * Battle process variation and waste throughout your organization

Required Reading
2006-02-23 Pharmaceutical Operations Management McGraw-Hill Professional
ISBN 9780071472494 ISBN-13 0071472495

This book brings together a winning team of international operations experts to set the framework for building a world-class manufacturing organization. Pharmaceutical Operations Management focuses on key concepts such as: Policy Execution, Risk Management, Supply chain modeling, Advance process control and Six Sigma for the pharmaceutical industry: critical techniques which will offset cost, increase efficiency and turn any manufacture into financial winner.

Required Reading
1998-02-11 Pharmaceutical Production Facilities Taylor & Francis
ISBN 9780748404384 ISBN-13 0748404384

Pharmaceutical Production Facilities: Design and Applications considers the concepts and constraints that have to be considered in the design of small, medium and large scale production plants. The layout, along with the flow of materials and personnel through facilities are considered with reference to ensuring compliance with current good manufacturing practice. The book explains how clean rooms have developed, and how recent regulations affect their design. The latest concepts for reducing contamination levels from the operator and the product are discussed. It assess current changes in standards and quality control and makes suggestions for the "ideal production environment" to enable standards to be validated to current standards.

Module Resources

Non ISBN Literary Resources

Already detailed


Journal Resources


URL Resources


Other Resources

Module Lecture Notes.

Additional Information