Have you ever thought about what is the ‘fil rouge’ that connects all regulations applicable to the pharmaceutical industry and within every regulation that relates all key processes?
The ‘fil rouge’ is the phenomenal concept of continuous improvement that removes the perception of regulations as something static and gives them a spin, a dynamic movement forward.
Continuous improvement is the idea that if we determine the actual root cause of an issue, a deviation, an audit finding, an adverse trend, or a peak in a series of measures, we can define actions that will address the root cause, meaning that will prevent the same event from happening again. This way, we created the spin that moves us forward to a different place from where we were and where that specific event will not repeat itself.
The same concept also applies to events that have not happened yet but that we know exist as the effects of uncertainty: risks and opportunities. Determining the root cause will enable us to mitigate or avoid the risk of materilizing or determine how to leverage an opportunity best.
With that in mind, we wanted to explore how the ‘fil rouge’ of continuous improvement underlies the key quality processes within a Quality Management System.
The 10-part series of articles under the name ‘The fil rouge that connects all quality processes’, starting with a 2-part article on ‘the role of the Business Process Owner within the Quality Management System’, results from our exploration and thoughts on continuous improvement.
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