CHEN40480 Lean Sigma Biopharma Process

Academic Year 2022/2023

The module provides an introduction to the concepts of operational excellence and examines their applications to the Life Sciences. This module examines all aspects of the application of Lean Processing and Six Sigma principles to Biopharmaceutical Processing. The material covered in this course is at a level between Yellow and Green Belt.

A non-standard mark-to-grade conversion system is used in this module for grades of C- and above (i.e. C-: 50.00-54.99; C: 55.00-59.99; C+: 60.00-64.99; B-: 65.00-69.99; B: 70.00-74.99; B+: 75.00-79.99; A-: 80.00-84.99; A: 85.00-89.99; A+:90.00-100.00).

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Curricular information is subject to change

Learning Outcomes:

On completion of this module students will be able to:

1. Evaluate and discuss the key principles and concepts of Operational Excellence.

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

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

4. Demonstrate 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.

Student Effort Hours: 
Student Effort Type Hours


Autonomous Student Learning


Online Learning




Approaches to Teaching and Learning:
On-line webinar sessions
Face-to-face sessions 
Requirements, Exclusions and Recommendations

Not applicable to this module.

Module Requisites and Incompatibles
Not applicable to this module.
Assessment Strategy  
Description Timing Open Book Exam Component Scale Must Pass Component % of Final Grade
Continuous Assessment: 3 assignments Varies over the Trimester n/a Graded No


Examination: Open book exam 2 hour End of Trimester Exam Yes Graded No


Carry forward of passed components
Resit In Terminal Exam
Spring No
Please see Student Jargon Buster for more information about remediation types and timing. 
Feedback Strategy/Strategies

• Feedback individually to students, post-assessment

How will my Feedback be Delivered?

Not yet recorded.

Name Role
Mr Jim McKiernan Lecturer / Co-Lecturer