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Risk Management in Quality Assurance: FMEA & HACCP for Irish Pharma
Report
Risk Management in Quality Assurance: FMEA & HACCP for Irish Pharma:
Introduction
Risk Management is an essential part of pharmaceutical quality systems in Ireland. Two widely used tools in the industry are Failure Mode and Effects Analysis (FMEA) and Hazard Analysis Critical Control Points (HACCP).
Key Risk Management Tools
📌 FMEA (Failure Mode and Effects Analysis) – Evaluates potential process failures, ranks risks, and implements mitigation strategies.
📌 HACCP (Hazard Analysis and Critical Control Points) – Applied in sterile manufacturing and food-grade excipients to control contamination risks.
Case Study:
FMEA in Pharmaceutical Tablet Manufacturing
• A Dublin-based pharma company used FMEA to assess risks in tablet compression. The analysis identified a high risk of weight variation, which was mitigated by implementing real-time tablet weight monitoring.
👉 Contribution:
I have developed FMEA and HACCP models, ensuring pharmaceutical companies proactively address potential quality failures before they impact product safety.
Risk management tools such as FMEA and HACCP help identify and mitigate potential failures in pharmaceutical processes. This project focuses on their application in Irish pharma, ensuring proactive risk control.