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Research Article Open Access
The failure mode and effect analysis is a very helpful tool for identifying week point in manufacturing of dosage form. Current available risk analysis techniques are well adapted to industry needs since they were developed for its purpose. Each failure mode was ranked on estimated frequency of occurrence (O), probability that the failure would remain undetected later in the process (D) and severity (S), each on a scale of 1–10 and scale is decided by team. Human errors turned out to be the most common cause of failure modes. Failure risks were calculated by Risk Priority Numbers (RPNs) =O×D×S. Failure modes with the highest RPN scores were subjected to corrective actions and the FMEA was repeated and showing reductions in RPN scores and found improvement index and resulting in improvement indices up to 5.0. Results indicate that the application of FMEA method can solve the problems that have arisen from conventional FMEA, and can efficiently discover the potential failure modes and effects. FMEA is an analytical technique that combines the technology and experience of people in identifying foreseeable failure modes of a product or process and planning for its elimination. It can also provide the stability of process assurance and improve the quality of product.
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Author(s): Prateek R. Gupta, M. A. Shende, D. M. Shaikh