QLTY07029 2019 QUALITY SYSTEMS

General Details

Full Title
QUALITY SYSTEMS
Transcript Title
QUALITY SYSTEMS
Code
QLTY07029
Attendance
N/A %
Subject Area
QLTY - Quality
Department
LIFE - Life Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Aodhmar Cadogan
Programme Membership
SG_SFORE_G07 201900 Bachelor of Science in Science in Forensic Invest & Analys(Emb) SG_SFORE_H08 201900 Bachelor of Science (Honours) in Science in Forensic Science and Analysis SG_SFORE_B07 201900 Bachelor of Science in Science in Forensic Investigation and Analysis
Description

This module provides the student with an overview of International Quality Management Systems, quality culture and tools for implementation of quality improvements with a particular emphasis on systems that would operate in testing and calibration laboratories, forensic laboratories and general manufacturing facilities. 

Learning Outcomes

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

1.

Illustrate the principle benifits and requirements of implementing a quality system.

2.

Select, explain and interpret the current revisions of ISO Standards such as ISO9000 and ISO 17025 and apply to case studies.

3.

Discuss analytical method validation in the context of good laboratory practices

4.

Employ quality tools to categorise and evaluate the root cause of a problem and suggest appropriate corrective action

5.

Design, use and revise a working document system for a pilot manufacturing and testing process and maintain detailed records

Teaching and Learning Strategies

This module will be delivered full time.  It will include lectures, laboratory practicals and site visits / guest speakers augmented by independent learning and self directed learning. This approach is expected to address student learning needs.  Moodle will be used a repository of educational resources and for uploading assessments.  Teamwork will be required in the practical laboratory sessions.

Module Assessment Strategies

The module is 50% continuous assessment and 50% final exam.

The  continuous assessment will take place through the laboratory lab sessions where each team will development and write a Quality manual for a simple manufacturing process and carry out the process creating records and revising procedures throughout.  The student will also participate in a workshop in analytical method validation.  A case study assignment will be used to familiarise the students with one of the  ISO standards or other international Laboratory Guideline.

The student must meet an assigned gate (mark) in the final exam and achieve 40% overall to pass the subject.

Repeat Assessments

Repeat Continuous assessment and/or repeat Final Exam 

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

Indicative Syllabus

Overview of the benefits of quality management systems (QMS) and the principles of quality management as set out in the ISO system.

Overview of the structure of ISO standards and current version of  ISO9001 and ISO17025

Regulations, standards, and codes of practice related to forensic investigation and best practice incl ISO 17020, ENFSI.

Purpose and features of different document types e.g.  Quality manual, procedures, forms.

Key processes in good change control systems and quality records.

Auditing, self inspection and corrective and preventive action.

Quality Tools: E.g. pareto analysis, SPC, fishbone diagram, PDCA cycles 

Good Manufacturing Practice (GMP) / Good Laboratory Practice (GLP) / ICH Analytical Validation guidelines 

Standard methods of analysis e.g. US pharmacopoeia, Water analysis, UNODOC 

Practical sessions to construct and operate a quality document system for a pilot process.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
50 %
End of Semester / Year Formal Exam
50 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Laboratory Practical -Development and write a quality document system. Continuous Assessment Practical Evaluation 40 % OnGoing 5
2 Assignment Case study Continuous Assessment Assignment 10 % Week 9 2
3 Short Answer questions and MCQ Formative Assessment - % OnGoing 1,2,3,4,5

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 End of semester Final Exam Final Exam Closed Book Exam 50 % End of Term 1,2,3,4
             
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Tiered Classroom Lecture 2 Weekly 2.00
Laboratory Practical Science Laboratory Practical 2 Weekly 2.00
Independent Learning Not Specified Self study 3 Weekly 3.00
Total Full Time Average Weekly Learner Contact Time 4.00 Hours

Required & Recommended Book List

Required Reading
2000-09-26 Quality Management Systems CRC Press
ISBN 1574442619 ISBN-13 9781574442618

Module Resources

Non ISBN Literary Resources

Quality Control for Dummies, Larry Weber and Michael Wallace, Wiley Publishing Inc, 2007.

Quality, Donna C. Summers, Pearson, 2014, Edition: 5th edition, ISBN: 9781292041780; 1292041781.

Journal Resources

Quality

URL Resources

International Standards organisation

https://www.iso.org/standards.html

International conference on Harmonisation (ICH)

https://www.ich.org/home.html

 

Other Resources

Library Database to access the standards from SAI Global

http://libguides.itsligo.ie/az.php?a=s

 

Additional Information

None