QUALITY MANAGEMENT SYSTEM: INTERNAL AUDITS. RESULTS OF THE AUDIT ACTIVITY CONDUCTED AT THE FACILITIES OF A UNIVERSITY HOSPITAL
European Statement
Patient Safety and Quality Assurance
Author(s)
Francesca Cammalleri, Giorgia Bo, Roberta Cutaia, Maria Laura Savi
Why was it done?
This project was initiated to institutionalize auditing as a standard, effective quality and safety tool. Our motivation was twofold, reflecting our commitment to patient care: first, to define and standardize audit procedures consistent with UNI EN ISO 9001; second, and most critically, to ensure safety action by verifying that correction plans drive real, measurable changes in medicine management, directly enhancing patient safety on the wards
What was done?
Between January 2024 and March 2025, a total of 14 structured internal audits were conducted. The verification cycle systematically assessed quality and safety compliance using a specific Checklist (incorporating UNI EN ISO 9001 requirements) and targeted inspection tools for pharmaceuticals specific areas. All findings and critical issues were formally documented in the ‘Internal Audit Report’ to ensure official follow-up
How was it done?
The auditing process utilized a systematic, structured approach. After distributing the comprehensive annual audit plan, verification was conducted using a checklist integrated with UNI EN ISO 9001 requirements. Recognizing drug management risks, pharmacist managers utilized the ‘Department Ward Cabinets Inspection Report’ for in-depth checks on storage conditions and restricted access. Findings were consolidated in the ‘Internal Audit Report’, initiating a resolution phase where minor non-conformities were resolved immediately, while others were formally scheduled for verified follow-up during the subsequent 2025 inspection cycle
What has been achieved?
The assessment established a high level of safety compliance, with all audited units demonstrating full compliance regarding optimal storage conditions and restricted access. Crucially, the audit cycle proved effective in identifying high-risk issues: three units were flagged for failing to separate narcotic drugs and concentrated potassium solutions, alongside two units maintaining excessive drug stock. Only one major non-conformity was identified across all units. This systematic approach resulted in a clear, actionable plan for continuous quality enhancement
What next?
The program is undergoing systematic follow-up and has led to immediate expansion: audits are continuing into 2025, with verification cycles already initiated in new, complex areas like surgical units. Furthermore, we have scheduled the full revision and update of the Pharmaceutical Management Document by the end of 2025. This continuous audit cycle is now a permanent cornerstone of our Quality System, driving sustained improvement and formal policy reinforcement
DEVELOPMENT AND IMPLEMENTATION OF A POST-AUDIT IMPROVEMENT PLAN IN A PARENTERAL NUTRITION PRODUCTION UNIT
Pdf
European Statement
Production and Compounding
Author(s)
F. Gaume, A. Ifrah, S. Vrignaud
Why was it done?
In 2023, an evaluation of professional practices (EPP) targeting the risk of microbiological contamination was carried out in our parenteral nutrition production unit. This EPP took the form of an internal observational practice audit and revealed several non-conformities (compliance with disinfectant exposure time, identification of right times for change gloves and performance of surface sampling) requiring the implementation of a structured and collaborative improvement plan.
What was done?
From January to October 2024, an improvement plan in 3 phases has been performed.
How was it done?
Phase 1 – Audit results: Presentation to unit technicians by pharmacists, followed by a discussion session.
Phase 2 – Development of improvement actions: Brainstorming sessions with the team to generate ideas for corrective actions / Evaluation of proposals collected according to 6 criteria (speed, relevance, feasibility, motivation, safety and cost) using an impact matrix / Creation of a structured action plan based on the selected proposals.
Phase 3 – Implementation of actions: Creation of working groups / Monitoring of the improvement process / Development of a plan to assess the effectiveness of actions.
What has been achieved?
Phase 1 – Audit results presentation: 2 sessions were held in January 2024 with the 13 technicians of the unit. The discussions allowed us to discuss the non-conformities observed during the audit and ensured understanding of the challenges identified.
Phase 2 – Development of improvement actions: 2 sessions were held in March 2024 /10 improvement actions were listed and evaluated. 4 actions were considered as priority, 4 as recommended and 2 as non-priority / Setting up of a Gantt chart to give an overview of the actions to be carried out, their estimated duration and deadlines.
Phase 3 – Implementation of actions: implementation of the 4 priority actions and the 4 recommended actions / Creation of a quality document concerning glove changes and modification of 8 quality documents / Consideration of ways of evaluating actions: quick audit, questionnaire, etc.
What next?
As a follow-up to this work, a questionnaire will be prepared for the technicians to assess the overall approach. A quick audit focusing on glove changes will be introduced soon to assess the impact of the improvement plan.