QLTY07036 2019 Essential Lean Six Sigma and Validation

General Details

Full Title
Essential Lean Six Sigma and Validation
Transcript Title
Essential Lean Six Sigma and V
N/A %
Subject Area
QLTY - Quality
MENG - Mech. and Electronic Eng.
07 - NFQ Level 7
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Mary Nolan
Programme Membership
SG_EMECL_B07 201900 Bachelor of Engineering in Mechanical Engineering SG_EPREC_B07 201900 Bachelor of Engineering in Precision Engineering and Design SG_EMTRN_B07 201900 Bachelor of Engineering in Mechatronic Engineering SG_EELCO_B07 201900 Bachelor of Engineering in Engineering in Electronic and Computing SG_EMTRN_J07 201900 Bachelor of Engineering in Mechatronic Engineering (Add-on) SG_EPREC_J07 201900 Bachelor of Engineering in Precision Engineering and Design SG_ETRON_J07 201900 Bachelor of Engineering in Electronic and Computer Engineering SG_EMECH_J07 201900 Bachelor of Engineering in Mechatronic Engineering SG_EMECH_H08 202000 Bachelor of Engineering (Honours) in Mechanical Engineering SG_EMTRN_J07 202000 Bachelor of Engineering in Mechatronic Engineering SG_EROBO_S07 201900 Level 7 Special Purpose Award in Robotics and Industrial Communications SG_ETRON_J07 202200 Bachelor of Engineering in Electronic and Computer Engineering (Add-on) SG_EELCO_B07 202200 Bachelor of Engineering in Electronic and Computing SG_EMTRN_J07 202300 Bachelor of Engineering in Mechatronic Engineering (Add-on) SG_EMTRN_B07 202300 Bachelor of Engineering in Mechatronic Engineering

This module examine various aspects of the application of Lean Manufacturing and Six Sigma principles and tools as they apply to modern manufacturing environment.  This module also introduces the student to the area of validation.

Learning Outcomes

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


Relate the history of quality development  to Lean, Six Sigma, Validation and Quality Management Standards


Evaluate and discuss the key principles of Six Sigma programmes and their application for manufacturing


Evaluate and discuss the key principles of Lean Manufacturing and their typical application for manufacturing.


Explain how validation principles are applied in a  process validation.


Interpret the Quality Management Standard  ISO9001 and connect how Lean and Six Sigma work together with the process approach.

Teaching and Learning Strategies

The course delivery will draw on various resources including:

  1. Traditional lecture.
  2. The students' own industrial experience.
  3. Work related assignments.
  4. Guest lecturers on topics that are topical and relevant.

Module Assessment Strategies

Continuous Assignments.

Final Exam.

Repeat Assessments

Standards set down by the institute apply.

Indicative Syllabus

Topics covered will include the following:

History of the development of quality

Lean Manufacturing Principles

Introduction to Lean Manufacturing Techniques- 5S programme, visual management, TPM (Total Productive Maintenance), waste analysis, SMED (Quick Changeover Techniques), overall equipment effectiveness (OEE).

Six Sigma Principles - DMAIC

Introduction to Six Sigma Techniques- SPC and Process Capability Analysis, pareto analysis, FMEA, Poka-Yoke (mistake-proofing), A3 reporting.

History of validation, give examples of incidents which have resulted in strict requirements today.

Stages of a validation project: URS, FDS, DQ, IQ, OQ and PQ,

Validation documentation, validation Master Plan, Validation Protocols and risk assessment.

ISO 9001 and the process approach



Coursework & Assessment Breakdown

Coursework & Continuous Assessment
20 %
End of Semester / Year Formal Exam
80 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Multiple Choise Questions Coursework Assessment Multiple Choice/Short Answer Test 5 % Week 3 1
2 Multiple Choise Questions Coursework Assessment Multiple Choice/Short Answer Test 5 % Week 7 2,3
3 Multiple Choise Questions Coursework Assessment Multiple Choice/Short Answer Test 10 % Week 11 1,2,3,4,5

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam Closed Book Exam 80 % Week 15 1,2,3,4,5

Full Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Lecture Theatre Lecture -Fulltime 2 Weekly 2.00
Tutorial Flat Classroom Tutorial 1 Weekly 1.00
Off-Site Activity Offsite Facility Company Visit 3 Once Per Semester 0.20
Total Full Time Average Weekly Learner Contact Time 3.20 Hours

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Distance Learning Suite Lecture online 3 Weekly 3.00
Total Online Learning Average Weekly Learner Contact Time 3.00 Hours

Required & Recommended Book List

Required Reading
2019-08 Equipment Qualification in the Pharmaceutical Industry Academic Press
ISBN 0128175680 ISBN-13 9780128175682

Equipment Qualification in the Pharmaceutical Industry provides guidance that needs to be included in quality qualification programs. The book outlines guidelines for the preparation and execution of qualification protocols, including Installation (IQ), Operational (OQ), and Performance (PQ) factors. In addition, it discusses the importance of related qualification programs (e.g., computer system and cleaning) and how to incorporate them into a fully compliant qualification program. Further, it provides matrices of what could be included for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the examples, matrices, and integration of related systems.

Required Reading
2015-11-16 Implementing ISO 9001?
ISBN 1908984503 ISBN-13 9781908984500

The latest edition of ISO 9001, published in 2015, is changing the way organisations are run worldwide. No longer is it sufficient simply to check on an organisation's quality management system: the revision demands that auditors assess the leadership and management of the quality system. This brings the standard alongside the widely proven system and process approach to continuing quality transformation that lies at the heart of the very best global companies.Over a million registered organisations around the world need to engage with the revised requirements. If you work for one of them the changes may be significant. In Implementing ISO 9001:2015 business transformation experts Jan Gillett, Paul Simpson and Susannah Clarke take managers step-by-step through the process needed for successful transition, improving results and facilitating a smooth audit. By applying the principles and methodologies, and using the book's templates and questions with their teams and suppliers, managers will transform the performance of their organisations. The tangible benefits will pay for the transition many times over.Implementing ISO 9001:2015 is a comprehensive guide to making the necessary transition to the new standard. The changes can also be used to stimulate transformation in organisations and their wider environments, coordinating processes to achieve both customer satisfaction and reduced operating costs. Follow this blueprint and certification comes as a free bonus!

Required Reading
2004-10-13 The Lean Six Sigma Pocket Toolbook: A Quick Reference Guide to Nearly 100 Tools for Improving Quality and Speed McGraw Hill Professional
ISBN 0071505733 ISBN-13 9780071505734

Vital tools for implementing Lean Six Sigma--what they are, how they work, and which to use The Lean Six Sigma Pocket Toolbook is today's most complete and results-based reference to the tools and concepts needed to understand, implement, and leverage Lean Six Sigma. The only guide that groups tools by purpose and use, this hands-on reference provides: Analyses of nearly 100 tools and methodologies--from DMAIC and Pull Systems to Control Charts and Pareto Charts Detailed explanations of each tool to help you know how, when, and why to use it for maximum efficacy Sections for each tool explaining how to create it, how to interpret what you find, and expert tips Lean Six Sigma is today's leading technique to maximize production efficiency and maintain control over each step in the managerial process. With The Lean Six Sigma Pocket Toolbook, you'll discover how to propel your organization to new levels of competitive success--one tool at a time.

Required Reading
2016-01-01 The Lean Toolbox 5th Edition
ISBN 0956830757 ISBN-13 9780956830753

This is the Fifth Edition of what has become a standard bestselling text on the tools, systems, and principles of Lean Manufacturing and Lean Operations. The Lean Toolbox covers Lean Philosophy, The Science of Lean, Improvement, Change, Strategy, Flow, Mapping, Scheduling, Layout, Quality, Product Development, Supply Chain, Lean Accounting, and Lean beyond the factory floor. It is aimed at managers and practitioners. Previous editions were known for their concise style and wide coverage. Over 110,000 copies of the previous editions were sold. The last edition was recommended by APICS for their International CPIM (Certified in Production and Operations Management) examinations. The book is prescribed by several universities in UK, USA, Denmark. The 4th edition remained on Amazon.co.uk's top 10 on manufacturing for 5 years. This is a complete revision and update including 40 additional pages.

Required Reading
2007 The Machine that Changed the World Free Press
ISBN 1847370551 ISBN-13 9781847370556

When James Womack, Daniel Jones, and Daniel Roos wrote THE MACHINE THAT CHANGED THE WORLD in 1990, Japanese automakers, and Toyota in particular, were making a strong showing by applying the principles of lean production. However, the full power of lean principles was unproven, and they had not been applied outside of the auto industry. Today, the power of lean production has been conclusively proved by Toyota's unparalleled success, and the concepts have been widely applied in many industries. Based on MIT's pioneering global study of industrial competition, THE MACHINE THAT CHANGED THE WORLD offers a groundbreaking analysis of the entire lean business system, including product development, supplier management, sales, service, and production - an analysis even more relevant today as GM and Ford struggle to survive and a wide range of British abd American companies embrace lean production. A new Foreword by the authors brings the story up to date and details how their predictions were right. As a result, this reissue of a classic is as insightful and instructive today as when it was first published.

Required Reading
2014-05-13 The Six Sigma Handbook, Fourth Edition McGraw-Hill Education
ISBN 0071840532 ISBN-13 9780071840538

The most complete, current guide to Six Sigma Best practices in Six Sigma are continuously evolving, just as Six Sigma itself evolved from earlier best practices in quality improvement. ...This fourth edition...(features) expanded materials on innovation, strategic development, Lean, and constraint management. ...Youll notice many references to free online materials within the text, such as Excel file templates that can be used for analyzing projects, or videos that provide an in-depth narrative on specific topics. Additional links will be added over time to further extend the learning potential offered by the text, so be sure to regularly check back into the online site at www.mhprofessional.com/SSH4. From the Preface by Paul Keller The Six Sigma approach is being used to vastly improve processes, profitability, sustainability, and long-term growth at global organizations of all sizes. Fully revised for the latest developments in the field, The Six Sigma Handbook, Fourth Edition, reveals how to successfully implement this improvement strategy in your company. The book explains how to define and deploy Six Sigma projects focused on key stakeholder requirements and carry out data-driven management. This comprehensive resource walks you through the phases of DMAIC and DMADV and demonstrates how to use the statistical tools and problem-solving techniques of Six Sigma with screenshots of Minitab and Excel applications. The new edition has been updated to include: Two online quizzes for Six Sigma certification, one for Green Belt candidates and one for Black Belt candidates Links to five videos that walk you through specific processes, such as Minitab functions, statistical process control, and how to read a Pareto chart Fully incorporated coverage of Lean methodologies Find out how to select the right personnel to train, achieve technical proficiency, build the best teams, and foster effective leadership. Improve the quality of processes and products in your organization, increase customer satisfaction, and boost profits with help from this definitive guide to Six Sigma. Written by two of the foremost authorities on the subject, this authoritative resource delivers all of the guidance you need to successfully implement Six Sigma. Comprehensive coverage includes: Building the responsive Six Sigma organization Recognizing and capitalizing on opportunity Data-driven management Maximizing resources Project management using DMAIC and DMADV The define phase The measure phase Process behavior charts Measurement systems evaluation The analyze phase The improve/design phase The control/verify phase

Required Reading
1998-04-30 Validation Fundamentals CRC Press
ISBN 1574910701 ISBN-13 9781574910704

Written by the founders of the Institute of Validation, this practical introduction to validation cuts through all the jargon and focuses on the essentials. Whether you are a novice or an experienced validator, this book will help you understand validation fundamentals and ways in which these principles can be bonded with quality assurance, enabling you to build the highest quality into your products. Beginning with definitions of validation, the authors guide you through all the basics, associated costs, responsibilities, policies, strategies, support activities, SOPs, Master Plans, and other related subjects. Packed with tools to help you follow the logic of the validation process, the book covers testing, certification, protocols, final reports, sign-offs, ways to create seamless audit trails, and other topics impacting the qualification of a system, equipment, and/or process.

Module Resources

Non ISBN Literary Resources


Journal Resources


Other Resources

Calculator with statistics functions.

Additional Information