The cost of quality. A simple statement and yet few companies in the pharmaceutical manufacturing industry are paying close enough attention to this concept. Corporate focus, and rightly so at times, is for the most part focused on compliance and meeting regulatory requirements to sell products across the globe. Those compliance regulations require companies to perform at a prescribed level and maintain certain required systems.
Some of those quality systems include familiar functions such as incoming inspections, preventative maintenance and calibrations, complaints and returns, recalls, inspection and CAPA teams, environmental monitoring, rework and reprocessing. These are supportive systems that every company must have to maintain its overall compliance with industry expectations, but they come with their own internal costs. These are generally highly visible, obvious items and are easily shown on financial statements, often with a simple calculation of the total number of employees, their time allocated to these tasks and their respective fully-loaded salaries for each system or group. There are however a significant amount of hidden and less obvious costs that come along with those systems. These costs can be very large, depending directly on the level of quality in each respective area. When these costs are high, they are directly tied to the concept of poor quality.
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