![]() Spreadsheets are designed to perform calculations on large sets of numerical data. Why does this disconnect exist? First, the tools used for risk assessment - primarily spreadsheets - are ill-equipped to handle even simple processes. There is clearly a disconnect between the regulatory expectations and the practice of risk assessment. Furthermore, the idea of identifying, understanding and controlling risks during the development of a manufacturing process is incorporated into the quality-by-design philosophy used in many industries and now being encouraged as part of the Pharma 4.0 initiative. Regulatory frameworks such as ICH Q8 and ICH Q9 refer frequently to risk assessment and there is an entire international standard (ISO 14971) dedicated to risk management. ![]() Decisions on which risks are most critical to patient safety and efficacy and subsequent approaches for mitigation must be based on sound, scientific principles. In the world of pharmaceutical and medical device development, risk assessment is an integral part of the product lifecycle because manufacturing processes are too complicated to test every possible variable. If this scenario is familiar to you, then you know that the process of risk assessment can be very frustrating and often viewed as a chore, a box to check, an exercise that does not really provide value. When the meeting wraps up, you only completed one unit operation and there are still six more to evaluate! You wake up in a sweat realizing you were dreaming.or maybe you weren’t dreaming… Unfortunately, this is the status quo and repeated at many companies around the world today. The meeting stalls yet again when the Quality group asks for documentation and data to substantiate the selected risk levels.įor very complex processes, spreadsheets can have numerous tabs and contain large amounts of information. The meeting leader states that this should be recorded in another tab of the workbook. Then, another team member asks how to assess the risk of the outputs in this unit operation to downstream unit operations. Decisions are made and justifications are written in a notebook or on a Post-it note. What is the difference between a 3 and a 4 or a 7 and an 8? Two individuals begin debating whether a risk is medium or high. ![]() The meeting quickly bogs down as attendees start asking about the meaning of the different risk values. The purpose of the meeting is to assign risk values for each input and output for the different unit operations in your process. On the wall, a monitor displays a spreadsheet showing the inputs and outputs of a complex manufacturing process in a vast matrix. You are sitting with a group of people around a table in a conference room.
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