Risk assessment of pharmaceutical preparations control process by FMECA methodology

Context
The main activity of the control laboratory affiliated to our university hospital is to transmit information to its customers regarding compliance with the specifications of a batch of pharmaceutical preparation. In anticipation of an eventual ISO9001:2015 certification, the laboratory focuses on continual improvement, risk management and customer satisfaction approach.

Objective
To carry out a prospective risk analysis of the preparation control process in order to identify failure modes, assess their potential impact and take appropriate corrective actions.

Material and method
A functional analysis of the operational process "quality control of preparations" was conducted. A multidisciplinary team (laboratory technicians, pharmacists, pharmacy interns and externs, health managers, hospital engineers) was set up to identify failure modes, their impacts and the associated criticality. Failure Mode, Effects and Criticality Analysis (FMECA) methodology was applied.
Impacts related to each failure mode were separated into 4 categories: impact on the quality of information, impact on preparations, impact on the laboratory and impact on the customers. Individual severities of these 4 impacts were added together to obtain total severity of the failure mode (S). A rating of this severity, occurrence (O) and detection (D) was determined according to a scoring scale constructed by the team to obtain Risk Priority Number which is used for making a criticality assessment (RPN= OxSxD).

Results
40 failure modes were identified. They mainly concerned control (42.5%), feasibility study (20%) and pharmaceutical validation (12.5%) steps. One risk was highlighted as critical (control process not initiated or expected time for initiation of the control process not respected), one risk was identified as major (controls to be carried out not or wrongly specified), 5 risks were moderate and 33 were low. Control request step appears to be the most at risk. After prioritizing the risks, corrective actions that must be undertaken were determined.

Discussion – Conclusion
This work allowed us to ascertain the factors that can affect the process, and set out priorities for action. FMECA method, despite its subjectivity, meets the requirements of ISO9001:2015 standard. The approach of its multidisciplinary team has contributed to develop further quality culture within the laboratory. Separation of impacts into 4 categories highlighted the elements most affected by the failure, limited subjectivity by facilitating severity rating and helped better target corrective actions to be implemented. Risk analysis was thus refined.

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