Quality rules, regulations and activities are a common and costly occurrence in the manufacturing field. Good Manufacturing Practise for instance, the quality norm regulating pharma manufacturing, requires an annual global investment of approximately 10 billion USD. Compared to that, the industry’s investment in quality activities in the innovation field is small to non-existent.
This is partly driven by a peculiar view, picturing innovation and quality rules as poles apart. Innovation is seen as the hot spot of creativity – not to mention creative chaos – while quality rules are associated with barriers, gates and fences, designed to preserve the existing and getting in the way of changes. From this point of view innovation and quality rules do not mix well and should be kept apart. The fact that this view comes with cost saving by avoiding quality activities in the innovation sector is frequently seen as an extra bonus. Does this “do not mix” attitude survive a closer analysis?
Manufacturing processes deliver clearly defined products, exactly specified through measurable parameters, allowing to assess product and process quality reliably and retrospectively. Innovation processes on the other hand deliver frequently just readouts from experiments that have been designed based on a hypothesis and will be interpreted in the frame of the same or a slightly modified hypothesis. Due to the inherent uncertainty and complexity of innovation, a reliable retrospective quality assessment is frequently not possible.
Most manufacturing processes are well established, frequently validated and usually known for years to deliver consistent products. Innovation on the other hand tends to use completely new and hardly tested technologies or applies established technologies in a new set up, in both cases operating with a rather reduced knowledge about technology or methodology performance and a dangerously low knowledge about result quality.
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