QLTY07029 2019 Quality Systems

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

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

Discuss analytical method validation in the context of good laboratory practices

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

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

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.

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 Continuous assessment and/or repeat Final Exam 

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.