QLTY08022 2019 Validation & Six Sigma 2
Full Title
Validation & Six Sigma 2
Transcript Title
Validation & Six Sigma 2
Code
QLTY08022
Attendance
N/A %
Subject Area
QLTY - Quality
Department
MENG - Mech. and Electronic Eng.
Level
08 - NFQ Level 8
Credit
10 - 10 Credits
Duration
Semester
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
JOHN DONOVAN, Michael Moffatt, Mary Nolan
Programme Membership
SG_EPREC_K08 201900 Bachelor of Engineering (Honours) in Precision Engineering & Design (Add-on)
Description
Validation
The aim of this module is to provide learners with the knowledge and skills needed to be able to undertake product and process validation and employ a range of industry standard protocols for validation, verification and qualification of products and processes.
Six Sigma 2
This module aims to provide learners with the statistical tools associated with the six sigma DMAIC philosophy specifically in the areas of Measure, Improve and control consistent with the ASQ and Quality America Green Belt Body of Knowledge. The student will be able to perform basic statistical analysis, develop and plots control charts, determine process and measurement capability. Minitab statistical software will be used to demonstrate and apply these statistical techniques.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Discuss the reasons for strict regulatory requirements in relation to validation
2.
Interpret the requirements of Eudralex Volume 4 Annex 15
3.
Analyze the different stages of a validation project and what happens at each stage
4.
Discuss process validation requirements and the lifecycle approach
5.
Interpret the different requirements which are necessary for a User Requirement Specification and how this links to the success of a validation project
6.
Explain the validation categories
7.
Discuss the importance of Validation in Industry
8.
Use the six sigma tools to implement control and monitoring systems.
9.
Develop control charts with Minitab.
10.
Develop control charts for variable and attribute data and interpret the results.
11.
Describe the experimental design terms and process.
12.
Perform one way analysis of variance.
13.
Perform basic hypothesis testing, e.g. Hypothesis testing of means.
14.
Perform exploratory data analysis using multi‑vari charts, correlation and simple regression.
15.
Perform process capability and process performance analysis and interpret the results.
16.
Calculate, analyse and interpret measurement systems.
17.
Describe and interpret the common probability distributions.
18.
Perform basic probability calculations by applying the probability rules and concepts.
Teaching and Learning Strategies
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Module Assessment Strategies
This is a combined module consisting of Validation and Six Sigma 2.
The student much pass both of these elements before they are considered to have passed the module.
Repeat Assessments
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Indicative Syllabus
Validation
Definitions
Verification, validation, retrospective validation, concurrent validation, prospective validation, process validation decision tree, qualification
Validation History
United States, Europe
Interested Parties
Food and Drug Administration (FDA), Irish Medicines Board (IMB), Global Harmonisation Task Force (GHTF), Centre for Devices and Radiological Health (CDRH), International Standards Organisation (ISO)
Sector Specific Codes, Requirements, Standards, Directives and Guidelines
Guideline on general principles of process validation, ISO 13485:2003, 21CFR 820, the orange guide, guide to good manufacturing practices (GMP)
Validation Documentation
Master Validation Plan (MVP), Validation protocol, Validation report, procedures, device master record (DMR), device history record (DHR)
Process Validation: Components
DQ, IQ, OQ, PQ and PV
Cleaning Validation
Rationale, Overview and requirements
Software Validation
Overview, General Principles of Software Validation
Related Topics
Calibration, Process Capability, Record keeping, complaints, auditing, FDA warning letters, CAPA, Labelling and Packaging Control
Facilities Infrastructure
Cleanroom protocol, Cleanroom validation, Utilities
Sterilisation Validation
Overview
Six Sigma 2
A. Probability and statistics
Drawing valid statistical conclusions
Distinguish between enumerative (descriptive) and analytical (inferential) studies, and distinguish between a population parameter and a sample statistic.
Central limit theorem and sampling distribution of the mean
Define the central limit theorem and describe its significance in the application of inferential statistics for confidence intervals, control charts, etc.
Basic probability concepts
Describe and apply concepts such as independence, mutually exclusive, multiplication rules, etc.
B. Probability distributions
Describe and interpret normal, binomial, and Poisson, chi square, Student's t, and F distributions.
C. Measurement system analysis
Calculate, analyze, and interpret measurement system capability using repeatability and reproducibility (GR&R), measurement correlation, bias, linearity, percent agreement, and precision/tolerance (P/T).
D. Process capability and performance
Process capability studies
Identify, describe, and apply the elements of designing and conducting process capability studies, including identifying characteristics, identifying specifications and tolerances, developing sampling plans, and verifying stability and normality.
Process performance vs. specification
Distinguish between natural process limits and specification limits, and calculate process performance metrics such as percent defective.
Process capability indices
Define, select, and calculate Cp and Cpk, and assess process capability.
Process performance indices
Define, select, and calculate Pp, Ppk, Cpm, and assess process performance.
Short‑term vs. long‑term capability
Describe the assumptions and conventions that are appropriate when only short‑term data are collected and when only attributes data are available. Describe the changes in relationships that occur when long‑term data are used, and interpret the relationship between long‑ and short‑term capability as it relates to a 1.5 sigma shift.
Process capability for attributes data
Compute the sigma level for a process and describe its relationship to Ppk.
E. Exploratory data analysis
Multi‑vari studies
Create and interpret multi‑vari studies to interpret the difference between positional, cyclical, and temporal variation; apply sampling plans to investigate the largest sources of variation.
Simple linear correlation and regression
Interpret the correlation coefficient and determine its statistical significance (p‑value); recognize the difference between correlation and causation. Interpret the linear regression equation and determine its statistical significance (p‑value). Use regression models for estimation and prediction.
F. Hypothesis testing
Basics
Define and distinguish between statistical and practical significance and apply tests for significance level.
Tests for means, and proportions
Define, compare, and contrast statistical and practical significance.
Single‑factor analysis of variance (ANOVA)
Define terms related to one‑way ANOVAs and interpret their results and data plots.
Chi square
Define and interpret chi square and use it to determine statistical significance.
G. Design of experiments (DOE)
Basic terms
Define and describe basic DOE terms such as independent and dependent variables, factors and levels, response, treatment, error, repetition, and replication.
Main effects
Interpret main effects and interaction plots.
H. Statistical process control (SPC)
Objectives and benefits
Describe the objectives and benefits of SPC, including controlling process performance, identifying
special and common causes, etc.
Rational subgrouping
Define and describe how rational subgrouping is used.
Selection and application of control charts
Identify, select, construct, and apply the following types of control charts: -R, -s, individuals and moving range (ImR / XmR), median, p, np, c, and u.
Analysis of control charts
Interpret control charts and distinguish between common and special causes using rules for determining statistical control.
I. Implement and validate solutions
Use various improvement methods such as brainstorming, main effects analysis, multi-vari studies, measurement system capability re-analysis, and post-improvement capability analysis to identify, implement, and validate solutions through F-test, t-test, etc .
J. Control plan
Assist in developing a control plan to document and hold the gains, and assist in implementing controls and monitoring systems.
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 | Contineous Assessment Validation | Coursework Assessment | Assessment | 10 % | OnGoing | 1,2,3,5,6,7 |
| 2 | Contineous Assignment Six Sigma 2 | Coursework Assessment | Assignment | 10 % | OnGoing | 8,9,10,11,12,13,14,15,16,17,18 |
End of Semester / Year Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Final Exam Validation | Final Exam | Closed Book Exam | 40 % | End of Term | 1,2,3,4,5,6,7 |
| 2 | Final Exam Six Sigma 2 | Final Exam | Closed Book Exam | 40 % | End of Semester | 8,9,10,11,12,13,14,15,16,17,18 |
Online Learning Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Distance Learning Suite | Theory Validation | 1 | Weekly | 1.00 |
| Tutorial | Distance Learning Suite | Tutorial Six Sigma 2 | 1.25 | Weekly | 1.25 |
| Lecture | Distance Learning Suite | Theory Six Sigma 2 | 1 | Weekly | 1.00 |
| Tutorial | Distance Learning Suite | Tutorial Validation | 1.25 | Weekly | 1.25 |
Total Online Learning Average Weekly Learner Contact Time 4.50 Hours
Required & Recommended Book List
Required Reading
Lean Six Sigma & Minitab Opex Resources
Lean Six Sigma & Minitab Opex Resources
Required Reading
2011-01-07 Six Sigma Demystified, Second Edition McGraw Hill Professional
ISBN 9780071760829 ISBN-13 0071760822
2011-01-07 Six Sigma Demystified, Second Edition McGraw Hill Professional
ISBN 9780071760829 ISBN-13 0071760822
Learning Six Sigma CAN be a painless process! Six Sigma is among the most effective process methods used today--and it's also among the most baffling topics to those new to the subject. The good news is Six Sigma DeMYSTiFieD, second edition, explains it all in a language you'll understand. This easy-to-understand reference teaches the methods of Six Sigma, explains their applications, and tests expertise--without confusing statistics and formulas. In no time, you'll develop the skills you need to solve problems, anticipate customer needs, and meet the demands of the most challenging markets. Filled with practical hands-on advice and essential organizational tips, Six Sigma DeMYSTiFieD provides a complete blueprint for developing strategies, plotting growth, and performing at peak efficiency for maximum profits. This fast and easy guide offers: Proven techniques for building a solid Six Sigma infrastructure Tips for deploying projects using DMAIC methodology Clear advice on when and how to use specific problem-solving tools Essential calculations and assumptions Case studies, quizzes, and a final exam that reinforce what you've learned Simple enough for a beginner but challenging enough for a more advanced student, Six Sigma DeMYSTiFieD is your shortcut to a solid foundation in this powerful improvement methodology.
Required Reading
2018-10-24 Statistical Process Control Routledge
ISBN 1138064262 ISBN-13 9781138064263
2018-10-24 Statistical Process Control Routledge
ISBN 1138064262 ISBN-13 9781138064263
The business, commercial and public-sector world has changed dramatically since John Oakland wrote the first edition of Statistical Process Control - a practical guide in the mid-eighties. Then people were rediscovering statistical methods of 'quality control' and the book responded to an often desperate need to find out about the techniques and use them on data. Pressure over time from organizations supplying directly to the consumer, typically in the automotive and high technology sectors, forced those in charge of the supplying production and service operations to think more about preventing problems than how to find and fix them. Subsequent editions retained the 'took kit' approach of the first but included some of the 'philosophy' behind the techniques and their use. The theme which runs throughout the 7th edition is still processes - that require understanding, have variation, must be properly controlled, have a capability, and need improvement - the five sections of this new edition. SPC never has been and never will be simply a 'took kit' and in this book the authors provide, not only the instructional guide for the tools, but communicate the management practices which have become so vital to success in organizations throughout the world. The book is supported by the authors' extensive and latest consulting work within thousands of organisations worldwide. Fully updated to include real-life case studies, new research based on client work from an array of industries, and integration with the latest computer methods and Minitab software, the book also retains its valued textbook quality through clear learning objectives and end of chapter discussion questions. It can still serve as a textbook for both student and practicing engineers, scientists, technologists, managers and for anyone wishing to understand or implement modern statistical process control techniques.
Required Reading
2007-09-25 Validation of Pharmaceutical Processes, Third Edition CRC Press
ISBN 0849370558 ISBN-13 9780849370557
2007-09-25 Validation of Pharmaceutical Processes, Third Edition CRC Press
ISBN 0849370558 ISBN-13 9780849370557
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process. Presenting theoretical knowledge and applied practical considerations, this title provides an in-depth discussion of recent advances in sterilization identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions
Required Reading
2017-01-06 Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2017
ISBN 0857112856 ISBN-13 9780857112859
2017-01-06 Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2017
ISBN 0857112856 ISBN-13 9780857112859
Commonly known as the Orange Guide, this book remains an essential reference for all manufacturers and distributors of medicines in Europe. It provides a single authoritative source of European and UK guidance, information and legislation relating to the manufacture and distribution of human medicines.
Module Resources
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Additional Information
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