Analysis of non-conformity in continuous quality improvement in a Hospital Radiopharmacy Unit

Area of Science:

• Radiopharmacy
• Quality Management Systems
• Nuclear Medicine

Background:

• Quality Management Systems (QMS) are crucial for radiopharmaceutical production.
• Regular analysis of non-conformities (NC) is essential for QMS review.
• The Radiopharmacy Unit sought to evaluate its QMS effectiveness through NC analysis.

Purpose of the Study:

• To analyze non-conformities (NC) registered between 2012 and 2015.
• To assess the effectiveness of the Quality Management System in the Radiopharmacy Unit.
• To identify trends and patterns in NC to improve quality assurance.

Main Methods:

• Analysis of registered non-conformities (NC) from 2012-2015.
• Categorization of NC by impact (critical, major, minor).
• Classification of NC by cause/origin and radiopharmaceutical type (PET vs. SPECT).

Main Results:

• A consistent annual decrease of 20% in NC was observed.
• PET radiopharmaceuticals showed a notable reduction in NC.
• SPECT non-conformities constituted 62-84% of total NC, primarily due to unadministered doses (1.5-3% ratio).

Conclusions:

• Non-conformity analysis serves as a valuable indicator for quality assurance assessment.
• The observed decrease in NC registration signifies successful implementation of corrective and preventive actions.
• Continuous monitoring of NC is vital for maintaining and enhancing radiopharmaceutical quality.