Implementation of an electronic non-conformities management in a preparation unit of chemotherapies
2 Lip(Sys)2, Chimie analytique pharmaceutique, Université Paris Sud, Paris Saclay, Chatenay-Malabry, France
In the framework of quality system management, an electronic management of non-conformities (NC) has been developed in the production and control unit (UPC) on the institutional software Kaliweb®. Three months later, results are presented here.
Based on previous paper reporting and overall risk analysis in the unit, a working group (2 pharmacists, a resident, a pharmacy technician and a quality engineer) has drawn up specifications focused on accessibility, usability and data mining. Using a computerized form, the declarant identifies the step of the process which initiates the NC and scores it severity and frequency, determining a criticality score (1 ≤ C ≥ 3). If C ≥ 2, the pharmacist who is the process manager receives an email alert and realizes a computerized follow-up with creation of an action form and feedback to the declarant. A management chart is used to monitor the progress of actions. Group training sessions were organized and after 3 months a quantitative assessment was carried out.
In total, 21 members of pharmacy staff were trained and 91 NC were declared from 13/04/2017 to 13/07/2017 (42 by pharmacists or residents, 27 by laboratory technicians, 21 by pharmacy technicians and 1 by orderlies), for an average of 1.5 declaration a day. The main source of NC is the preparation step (45 NC versus 29 in pre-fabrication step and 17 in post-fabrication step). Among the 55 (60%) NC which have a C ≥ 2, 47 (85%) were taken into account, resulting in 15 corrective actions (5 documentary resources, 2 training sessions, 5 organizational revisions and 3 revisions of materials and equipment).
Many declarations and initiated corrective actions show the efficiency of the system. A bi-monthly review will allow to continue the experience and motivate the team to declare NC. Finally, a study to evaluate the satisfaction of the users is planned to improve the tool.