Increased efficiency of administrative processes through optimized qualification and validation

Background

Efficiency in administrative processes is crucial to the success of any organization. In the context of qualification, which comprises the IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) steps, as well as the Validation new systems, it is clear that this process is extremely demanding and involves many departments. This complexity often leads to numerous meetings, long processing times and sluggish decision-making processes.

Actual state

The qualification processes are clearly defined, with several standard operating procedures (SOPs) describing their implementation in detail. Departments such as Quality, Production, Engineering, Finance and Purchasing work closely together. Nevertheless, the decision-making process - especially for risk analyses - is lengthy and labor-intensive. The preparations for qualification take at least six months, followed by the actual qualification, which is carried out in cooperation with suppliers. After a comprehensive test program, validation is carried out, which is also time-consuming and takes at least six months. These factors lead to a total lead time of often up to twelve months, which greatly impairs the ability to plan and control the overall process.

Negative effects

The tight procedures of the qualification and validation processes cause considerable delays, which have a negative impact on the overall projects. The high personnel commitment costs resulting from the large number of committees lead to unclear financial expenditure. This results in a costly and extremely slow process, which not only leads to a loss of time but also to considerable financial losses.

Our solution and future state

In order to increase efficiency and improve administrative processes, we are aiming for a comprehensive restructuring of the qualification and validation process. The overall process will be divided into various sub-streams that can be processed largely independently of each other. This agile transformation makes it possible to improve the controllability and speed of the processes. By partially loosening the close interlocking of decisions between the various departments, they are given more freedom and responsibility.

Importance of efficiency in agile processes

Efficiency plays a central role in agile processes as it is directly linked to a team's ability to deliver results quickly, cost-effectively and with high quality. The key aspects of efficiency in agile processes are explained below:

• Speed and flexibilityAgile methods, such as Scrum or Kanban, are designed to enable rapid adaptation to changing requirements. High efficiency in these processes means that teams are able to react quickly to changes, reprioritize and implement new requirements without compromising the quality of the work.
• Conservation of resourcesEfficient agile processes make optimal use of resources such as time, personnel and materials. This not only reduces costs, but also boosts employee motivation as they waste less time on inefficient processes. Targeted use of resources improves the overall productivity of the team.
• Quality of the resultsIn agile processes, the quality of the results is continuously ensured through regular reviews and adjustments. Efficiency here does not only mean speed, but also that the developed products or services meet the defined standards and the needs of the customers. Efficient teams focus on delivering valuable results quickly, which leads to higher customer satisfaction.
• Team autonomy and responsibilityAgile processes promote the personal responsibility of team members. Efficiency in this context means that teams are empowered to make decisions quickly and based on their expertise. This leads to fewer bureaucratic hurdles and speeds up decision-making, which increases the efficiency of the entire process.
• Continuous improvementEfficiency in agile processes is a continuous process. Teams regularly analyze their ways of working to identify opportunities for improvement. This promotes a culture of continuous improvement in which solutions are developed to eliminate obstacles or inefficiencies. This feedback system is essential in order to work efficiently in the long term.
• Customer centricityAgility places a strong focus on the needs of customers. The pursuit of efficiency ensures that teams are able to deliver services or products quickly and adaptably, tailored precisely to the customer's requirements. This strengthens the bond with customers and ensures their satisfaction.

In summary, it can be said that efficiency in agile processes has a direct influence on the performance of a team and the quality of the results. By focusing on speed, resource conservation, quality assurance and continuous improvement, agile teams create a dynamic and adaptable working environment that ultimately leads to business success.

Result

The results of these measures are convincing:

• The newly designed preparation for the qualification reduces the time from around six months to just 3-4 weeks.

• Preparation for validation is also shortened from six months to approx. 4 weeks.

• The process costs are reduced to around 500 hours, whereas they previously amounted to several thousand hours, which corresponds to a financial outlay of around € 75,000 instead of around € 750,000.

• The departments are able to achieve stable throughput times and significantly improve the predictability of the overall process.

• The budget can now be adhered to both in terms of time and money.

In addition to increasing efficiency

A central element of optimization is the targeted training of employees in order to improve their understanding of the new processes and reduce uncertainty. A clearly structured training program ensures that everyone involved acquires the necessary knowledge and skills to perform their tasks independently and on time. This initiative not only boosts motivation, but also strengthens the sense of ownership within the teams.

Regular feedback rounds and open communication channels enable the teams to continuously identify and implement opportunities for improvement. The integration of agile processes ensures that the adaptability and speed of response of the entire team is increased, which simultaneously improves the quality of the work results and strengthens trust between the departments.

Conclusion

Overall, it can be seen that consistent validation and qualification, taking efficiency into account, represent significant added value for any organization. Agile transformation not only enables an effective problem-solving strategy, but also contributes to long-term improvements in competitiveness. With a clear focus on efficient workflows and the continuous improvement of administrative processes, we create a solid foundation for future success.