RC REDOL Risk Management: be prepared for anything!

Pharmaceutical manufacturing is a complex operation, and with that complexity, a diverse set of problems can arise. Nevertheless, the implementation of quality processes to predict the occurrence and minimize the possible negative outcomes of errors is the recommended practice, better known as Risk Management. Read more about it below and find out how to be guided during the process by industry experts from RC REDOL.

So, what is Risk Management actually? In practice, it is a structured process that helps organizations to be less affected by the risks inherent to Pharmaceutical Operations, reduce the costs of associated risk events and improve overall organizational performance.

Effectively, Risk Management refers to the process of identifying, assessing, and controlling risks that may negatively impact an organization or project and its goal is to minimize the likelihood and impact of these risks, by developing a Risk Management Plan. This process typically involves the following steps:

  1. Risk identification, which means identifying potential risks that could impact the organization or project.
  2. Risk analysis, where each identified risk is analysed to determine the likelihood of its occurrence and the potential impact it could have.
  3. Risk evaluation or, in other words, evaluating each risk to determine the level of risk and the appropriate response.
  4. Risk reduction, which is enabled by developing a plan to reduce or eliminate the impact of identified risks.
  5. Risk acceptance, which is the point where formal decision to accept the risk is made, after reduction to an acceptable level.
  6. Risk monitoring and review, which involves monitoring the effectiveness of the risk management plan and reviewing it regularly to ensure that it remains effective.

This tool is nearly mandatory when conducting operations in the Pharmaceutical Industry, namely due to the complexity of said operations and due to the high impact of potential errors. It should, therefore, be the subject of detailed and knowledgeable work, to ensure minimal repercussions.

To that extent, RC REDOL’s experts can provide you with the guidance and knowledge you need to place an effective and efficient Risk Management Plan, so make sure you contact us inquiring about our services. We can and will make a difference in your operations, optimizing and safe-proofing your processes, so that you can keep your focus on manufacture while supported by industry leading experts.

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