Lean Quality and Compliance - Processes Can Detox Too
In light of this, the ARCONDIS Lean experts unanimously agree that “administrative” quality and compliance processes must be considered value-enabling or even value-adding, although they do not contribute to the tangible value of the product itself.
Consequently, ARCONDIS project teams are working with selection criteria developed specifically for the pharmaceutical and medical device industry to identify value-adding process steps. Using Lean principles to streamline business processes does not compromise the quality of the product. On the contrary: all that remains is value-adding.
Turning a theory into success
So how exactly can we transform quality processes into Lean processes? First, the greatest wastes are identified, for example via process interviews or documentation assessments. In a second analytical phase, the underlying “pain points” are tackled. This can be achieved particularly elegantly using a Makigami process mapping, which addresses gaps between documented (analysis of SOPs, i.e. standard operating procedures) and real-life processes (work sampling, Gemba walks), while taking into consideration process flaws and their causes.
Once the value-adding process steps have been identified, the elimination of unnecessary steps is verified (proof of concept) and later carried out based on short- to medium-term action plans.
Practical experience has shown that the sustainability of process optimization efforts can be further ensured by implementing results-based feedback loops (e.g. via KPIs) that are ideally supported by visual management. An employee-driven CIP (continuous improvement process) and a standardized virtual meeting culture additionally help to increase the efficiency of the quality and compliance departments.
People as a key factor
The methods alone are, of course, not enough: an effective organizational change management is just as important. In an environment characterized by meticulously documented quality processes (SOPs) and authority inspections, employees tend to be skeptical of simplification. Common biases, such as the link between downsizing processes and layoffs, must be eliminated, and the risk-averse mentality in the field of life sciences quality management needs to be guided to new grounds.
To initiate and successfully implement such changes, it takes experts with solid experience in the relevant quality processes, the Lean methods and organizational change management. This combination of competences ensures that Lean projects target the appropriate spots of the organization while maintaining compliance without putting the organization itself at a disadvantage.
■ Dr. Daniela Boettger-Schmidt
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