This module introduce the student to the quality regime required in the healthcare industry and the importance of records
Good Laboratory Practice:
Applying Good Laboratory Practice. The Quality Assurance Unit. Standard Operating ProceduresAccreditation of Laboratory facility.
Good Manufacturing Practice:
Definition of manufacturing process. Provision of necessary facilities e.g. suitable equipment and services. Writing of procedures. Training. Documentation e.g. records of manufacture. Recall system.
Introduction to Quality Systems:
ISO 9000 series of standards. ILAB requirements. Gaining Accreditation. Setting up a quality system. Auditing the system. Certification Registration. TQM.
Introduction to Process Validation:
Design qualification. Installation Qualification. Performance qualification. Documentation hierarchy.
Introduction to Hazard Analysis and Critical Control Points (HACCP):
Pro-active control. Identification of process critical control points (CCPs). HACCP implementation to a process. Role of the Food Safety Authority of Ireland (FSAI).
Introduction to Appropriate Standards:
Department of Health guidelines/regulations. European directives. FDA guidelines. ISO standards.ILAB requirements. NSAI standards.
Introduction to Audit Requirements:
Preparing for the audit. Error or defect investigation and follow up. Internal and external auditing. Towards a TQM standard for self-assessment. Corrective actions. Continuous improvement.
Workplace Quality
Introduction to Workplace Examples of Quality Implementation
Quality Risk Register
Examination od a typical quality risk register as used in the Healthcare sector
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |