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Failure Mode and Effects Analysis (FMEA) – a General Overview

Guest Post by Daniela Siu Manzano and Dante Amatangelo, PQE Group
May 23, 2023

All biopharmaceutical companies in the process of developing a new drug or medical device, which requires the use of a complex manufacturing process involving multiple steps, will want to ensure that the process is designed and controlled to minimize the risk of failures that could affect the efficacy of the manufactured drug or medical device.

FMEA is a risk assessment tool commonly used to identify potential failures in a system, process or product and assess the severity of their consequences. FMEAs can be conducted at biopharmaceutical companies to evaluate the process of the manufacturing of a new drug or an existing one if a FMEA was not performed in the past.  There are five (5) main steps for performing a FMEA for a biopharmaceutical facility. 

  1. Assemble a cross-functional team – The first step is to assemble a team of experts from different areas of the company, including manufacturing, quality control and process development. The team is responsible for identifying potential failure modes and developing strategies to mitigate the risks associated with each mode.
  • Identify potential failure modes – The team begins by reviewing the process, steps, instruments, equipment and systems involved in the manufacturing of the product and identifying all the potential failure modes that could occur for each of these. Some failures might include contamination of the product, inadequate mixing of ingredients or equipment failure.
  • Determine the severity, occurrence, and detectability of each failure mode – Once the potential failure modes have been identified, the team assesses each mode’s severity, occurrence and detectability. Severity refers to the potential impact of the failure mode on the product or patient. Occurrence refers to the likelihood of the failure mode occurring, while detectability refers to the likelihood of the failure mode being detected before it affects the product or patient.
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  • Calculate the Risk Priority Number (RPN) for each failure mode – The team calculates the Risk Priority Number (RPN) for each failure mode by multiplying the severity, occurrence and detectability scores. The RPN is a clear indicator that preventive, corrective or improvement actions should be implemented to prevent the occurrence of failures, and is used to rank and identify failure modes that require more attention to be eliminated.
  • Develop strategies to mitigate the risks – Finally, the team develops and implements strategies to mitigate the risks associated with each failure mode, focusing on the failure modes with the highest RPN scores. These strategies may include implementing additional quality control measures, improving equipment maintenance or adjusting the manufacturing process to reduce the probability of failure.

The FMEA tool helps biopharmaceutical companies to ensure regulatory compliance of the manufacturing process; it is designed to minimize the risk of any failure and to address any failure before it can affect product quality or safety, before the product is released to market.