# BIO09052 2019 Lean Sigma for BioPharma

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**Description**

This module examines all aspects of the application of Lean Processing and Six Sigma principles to Biopharmaceutical Processing.

### Learning Outcomes

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

**1.**

Evaluate and discuss the key principles of Lean Manufacturing and their typical applications for bioprocess industries.

**2.**

Evaluate and discuss the key principles of Six Sigma programmes and their typical applications for bioprocess industries.

**3.**

Appraise the application of Lean tools such as Value Stream Mapping, SMED, 5S, Visual Management, TPM, Kaizen Events, Creating Continuous Flow.

**4.**

Appraise the application of Six Sigma tools such as DMAIC, Process Centering and Variation Reduction, SPC, PCA, QFD, FMEA, Poka-Yoke, HACCP, ANOM, ANOVA.

**5.**

For a typical biopharmaceutical process demonstrate the application of a combination of Lean-Sigma tools for both a core manufacturing process sequence as well for a support function or administrative sequence.

### Teaching and Learning Strategies

This module can be taught using via on-line lectures. A range of Computer-Aided Learning (CAL) packages are also used to support this module (e.g. Moodle, Adobe Connect, Panopto, Camtasia). Students are provided with electronic materials for self-assessment and preparation for assessments/assignments. Self-directed, student-centred, independent learning is a core aspect through completion of module coursework.

### Module Assessment Strategies

The assessment approach for this module will be 100% continuous employed including some of the following:

Enquiry based Projects, Assignments/mini projects. Short-form assessment exams incl. MCQs, Short answer and Long Answer Questions as required.

### Repeat Assessments

Students will have opportunities to re-submit work as agreed with their lecturer.

### Indicative Syllabus

Topics covered will include the following:

- Introduction to Lean Principles.
- Introduction to Six Sigma Principles.
- Value Stream Mapping for Processes.
- SMED (Quick Changeover Techniques).
- Creating Continuous Flow for Processes.
- 5S Programme and Visual Management Techniques.
- TPM - Total Productive Maintenance.
- Conducting a Kaizen Event.
- DMAIC approach to problem solving.
- Process Centering and Variation Reduction.
- SPC (Statistical Process Control) and Process Capability Analysis.
- Application of analytical tools such as A3 reporting, QFD, FMEA, Poka-Yoke (mistake-proofing), HACCP, ANOM, ANOVA.

### Coursework & Assessment Breakdown

**Coursework & Continuous Assessment**

### Coursework Assessment

Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
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1 | MCQ 1 | Continuous Assessment | Multiple Choice | 15 % | Week 5 | 1,2 |

2 | MCQ 2 | Continuous Assessment | Multiple Choice | 15 % | Week 12 | 3,4 |

3 | Assessment 1 | Continuous Assessment | Assignment | 20 % | Week 6 | 5 |

4 | Assessment 2 | Continuous Assessment | Assignment | 25 % | OnGoing | 3 |

5 | Assessment 3 | Continuous Assessment | Assignment | 25 % | OnGoing | 4 |

### Part Time Mode Workload

Type | Location | Description | Hours | Frequency | Avg Workload |
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Lecture | Not Specified | Lecture | 2 | Weekly | 2.00 |

Independent Learning | UNKNOWN | Self Study | 7 | Weekly | 7.00 |

### Required & Recommended Book List

**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**

2010-12-09

*Lean Six Sigma Demystified, Second Edition*Mcgraw-hill

ISBN 0071749098 ISBN-13 9780071749091

Your LEAN and mean guide to Lean Six Sigma Ready to implement better, faster, cheaper, more-profitable processes in your organization? Lean Six Sigma Demystified, Second Edition, shows you how to use proven techniques for simplifying, streamlining, and optimizing business practices for maximum productivity and profitability. Written in a step-by-step format, this practical guide covers the fundamental methods and tools of Lean Six Sigma. You'll get details on reducing defects and deviation, sustaining improvements, and achieving laser-focused process innovations. Measurement systems analysis (MSA), Design for Lean Six Sigma, and statistical tools such as analysis of variance (ANOVA) are also discussed. Clear examples, helpful diagrams, and concise explanations make it easy to understand the material, and end-of-chapter quizzes and a final exam reinforce key concepts. It's a no-brainer! You'll learn about: The seven speed bumps of Lean Value stream mapping and spaghetti diagramming Control charts, Pareto charts, and Ishikawa diagrams to laser-focus improvements Excel power tools for Lean Six Sigma Lean Six Sigma tar pits Ways to implement Lean Six Sigma to maximize results and minimize costs Simple enough for a beginner, but challenging enough for an advanced student, Lean Six Sigma Demystified, Second Edition, is your shortcut to this powerful improvement methodology. You'll also get a 90-day free trial of Q1 Macros software for Lean Six Sigma.

**Required Reading**

2018-05-29

*Lean Six Sigma For Leaders*John Wiley & Sons

ISBN 9781119374749 ISBN-13 111937474X

A refreshingly practical guide to real-world continuous improvement Lean Six Sigma for Leaders presents a no-frills approach to adopting a continuous improvement framework. Practical, down-to-earth and jargon-free, this book outlines the basic principles and key points of the Lean Six Sigma approach to help you quickly determine the best course for your company. Real-world case studies illustrate implementation at various organisations to show you what went right, what went wrong, what they learned and what they would have done differently, giving you the distilled wisdom of hundreds of implementations with which to steer your own organisation. Written from a leader's perspective, this quick and easy read presents the real information you need to make informed strategic decisions. While many organisations have implemented either Lean or Six Sigma, there is a growing interest in a combined approach; by implementing the most effective aspects of each, you end up with a more potent, adaptable system that benefits a wider range of organisations. This book shows you how it works, and how to tailor it to your organisation's needs. Understand the basic principles and key aspects of Lean Six Sigma Examine case studies of organisations that have implemented the framework Build on the lessons learned by other leaders to shape your own path Achieve continuous improvement by creating the right environment for success In theory, every organisation would like to attain continuous improvement but what does that look like in day-to-day practice? How is it structured? What practices are in place? How can you implement this new approach with minimal disruption to daily operations? Lean Six Sigma for Leaders answers these questions and more, for a clear, actionable guide to real-world implementation.

### Module Resources

**Non ISBN Literary Resources**

Womack, J.P and Jones, D.T., Lean Thinking, Free Press, 2003

Balle, F and Balle, M., The Gold Mine: a Novel of Lean Turnaround, Lean Enterprise Institute, 2005

Bicheno, J., The Lean Toolbox, Piscie Books, 2004

Friedli, T et al., Operational Excellence in the Pharmaceutical Industry, Editio Cantor Verlag., 2006

Pyzdek, T., The Six Sigma Handbook, McGraw-Hill, 2003

**Journal Resources**

See Moodle module site

**URL Resources**

See Moodle module site

**Other Resources**

See Moodle module site

**Additional Information**

See Moodle module site