Introduction Quality Control (QC) may be only one part of the value stream in a pharmaceutical company, but a QC with inef- ficient operations can disturb the flow in the entire value stream. Cost and responsiveness to market needs are two major concerns for companies across sectors, and it is necessary for all departments to perform optimally if the company is to remain competitive. Delays in QC can have a negative impact on product supply operation and can, in worst-case scenario, result in late delivery to customers. Delays in production batch releases also hurt the bottom line. Even if there are no delays because the QC depart- ment has hired additional resources, the impact of ineffi- cient operations will still be negative on the bottom line. In an effort to keep up, many QCs work at maximum capaci- ty or even above. This has a negative impact on operation planning and inventory, which again has far-reaching consequences in the company’s supply chain. The focus in this paper is therefore on the QC depart- ment, which has shown to often have major unrealised potential. Pharmaceutical companies, food and beverage companies, hospitals, chemical manufacturing companies, etc. have traditionally focused on lean on the shop floor but there can be millions to be saved in product supply by optimising operations in QC. You will not only realise tan- gible benefits but also help avoid delays in product supply. How to unlock the full potential By combining operational excellence with data-driven insight and powerful change leadership practices, QC departments have achieved productivity improvements of 15-20% or more. And these improvements are achieved within months. As the below figure illustrates, many manufacturing com- panies have already implemented some level of lean in their departments, which traditionally helps them realise efficiency improvements of 10-15%. However, by going beyond conventional lean initiatives and building on those improvements, these companies have proven that it is possible to achieve further efficiency improvements of 15-20% in a QC department. This paper will also provide examples of how they have achieved these improvements, not least in one of the world’s leading pharmaceutical companies. E ciency improvement % This whitepaper focusses on the the flow in QC 40 35 30 5-10% efficiency gain in 25 the total value stream Our approach 15-20% efficiency gain in QC enables a total of 20 30-45% in QC 15 efficiency gains 10 10-15% efficiency gain in QC 5 Conventional lean Flow in QC L L e e a a n n m m a a t t u u r r it it y y Transform the entire value stream Figure 1: High efficiency gain across the lean maturity levels - up to 30-45% The figures and examples in this whitepaper are based on our work in 12 QC labs in four different countries. The results have been achieved in both chemical and micro- biological laboratories in pharmaceutical companies, and similar results have been achieved in QCs in other indus- tries as well. In the following example from a leading pharmaceutical company, one of their QC functions achieved a productiv- ity gain of 17% in total. The QC function had already im- plemented several other lean initiatives and was ready to move to the next level of operational excellence. Notably, the results were achieved without any increase in absence or stress levels. It was simply a question of working more efficiently and having control of the processes. It was in essence about working smarter, not harder. And the results were achieved within less than a year. 4
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