Mistakes benchtop simulation: case in a quality control laboratory

Cécile Boughanem, Monique Mikaelian, Mélisande Bernard, Véronique Planas
Quality control departement, PE of AP-HP, AGEPS, France

Introduction
Uncompliances to Good Manufacturing Practices (GMP) are sometime notified when proceeding analysis in our quality control laboratory belonging to a pharmaceutical establishment. To improve its quality’s management, a long term training of the whole staff with a “mistakes benchtop simulation” was implemented. The mistakes benchtop is a transposition in a laboratory of the known tool “chamber of errors”.

Materials et methodes
Three scenarios were created according to the GMP. Each scenario included 11 errors from 5M Method (materials, methods, manpower, machines and management). These errors were chosen based on the main differences observed in our laboratory, traceability and documentation ones were identified as the most critical. The sessions were conducted with 4 to 6 individuals per group. Each person had 15 minutes to identify errors, followed by a 10 minutes debriefing with a pharmacy resident. At the end of the session, a satisfaction survey was filled out by the participant, and an information sheet about GMP was also delivered. A general presentation of the anonymized results was given to the whole staff after the experiment.

Results
There were fifteen participants in the survey: 9 technicians, 3 interns, 2 residents and 1 pharmacist. 6 out of 11 were identified on average (minimum 4; maximum 8). The most frequently were about the equipment: the scale’s dirtiness (100%), an automatic pipette laid flat on a benchtop (80%) and an unqualified device (75%).The 6 major errors were only identified in 50% of cases: 83% for an unsigned procedure, 40% for the data written on a loose sheet and 33% for product’s batch number difference with one written on analysis files. Less identified errors were those linked to the sustainable development (9%). Some unplanned errors were also noted by the participants (false positives). The participant’s global satisfaction was of 8.2/10.

Discussion-Conclusion
This educational tool provided important GMP reminders. It participates to the continuous training of the whole laboratory staff. The interactive and entertaining sides, as well as the adaptation of the errors to everyday practice, are the most positive aspects of this project. This trial will be remade as the participants enjoyed it, with a focus on traceability or environment’s respect. Duos will also be implemented to favor teamwork and allow more freedom in the errors research.

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