Risk mapping in quality control of Volatile Fatty Acid solutions : An FMEA study

Background
Volatile fatty acids (VFAs) are essential molecular activators required for colonocytes survival ans function. In our compounding unit, VFA solutions containing three main active components (acetate, propionate, and butyrate) are prepared as hospital preparations used in stoma care, particularly enemas, to improve patient comfort. A new multi-step quality control method incorporating HPLC quantification was recently implemented to verify the concentrations of these three main VFAs.

Objectives
This study aimed to establish a risk map for the quality control of hospital-prepared VFA solutions by identifying critical steps in the process, assessing risks, and defining corrective actions.

Materials and Methods
A risk analysis was conducted for each step of the VFA solution quality control process, from sample receipt to batch release, using the FMECA method (Failure Modes, Effects, and Criticality Analysis). Risk situations were mapped using a three-level criticality matrix based on frequency and severity scales, and corrective actions were defined for the critically highest situations.

Results
Risk mapping of the VFA quality control process identified 22 risk situations across six process phases: 5 with criticality level 1, 14 with criticality level 2 (requiring monitoring), and 3 with criticality level 3 (requiring corrective actions). The first involved manual recording of samples and results during quantification, which was addressed by implementing a procedure for data recording and analysis using dedicated software. The second concerned the possible presence of air in the HPLC system tubing, for which systematic checks during mobile phase changes are now in place. The third critical situation involved the use of a worn HPLC separation column, addressed by introducing a tracking table to ensure traceability of its use.

Discussion/Conclusion
This study highlights the most at-risk step: HPLC analysis, accounting for 8 out of 22 risk situations. Standardiazing procedures and improving traceability at each stage of the analysis should help reduce the criticality of identified scenarios. Assessing residual risk after implementation of these corrective measures would be relevant to validate their effectiveness and adjust them if necessary.

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