<![CDATA[This study assessed pharmaceutical tablet-manufacturing risk before and after a coordinated process-improvement programme using Failure Mode and Effects Analysis (FMEA). It focused on identifying and ranking failure modes, comparing their Risk Priority Numbers (RPNs), and quantifying residual risk reduction for the AL-MAG 1050 mg tablet line at Alben Healthcare Industries Limited, Nigeria. A retrospective before-and-after industrial risk-evaluation design examined 100 production-batch and quality records from 2022 to 2024. Eight baseline FMEA entries were screened, with four matched failure modes retained: capping, lamination, moisture drift and tool wear. The intervention tightened granule-moisture, blending-time, compression-speed and compression-force windows alongside revised Standard Operating Procedures, process monitoring and tooling controls. Risk reduction was evaluated descriptively using paired RPNs, absolute change, percentage reduction and residual ranking. Capping (50.10%) and lamination (23.57%) dominated the baseline defect burden. Post-intervention RPNs decreased from 280 to 120, 240 to 110, 210 to 95 and 190 to 90, respectively. Reductions ranged from 52.63% to 57.14%, while the aggregate descriptive RPN index declined by 54.89%, from 920 to 415. Despite these improvements, the ranking remained unchanged, with capping retaining the highest residual priority. The findings support continued risk-based surveillance of compression-related failure mechanisms]]>
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