Two large hospitals in the Stockholm region were in the process of modernizing their radiotherapy departments by investing in complex hardware and software for cancer treatment. The assigned supplier could not live up to the requirement specification according to the evaluation model, which resulted in discrepancies in the contract implementation.
Aneheim Consulting was tasked with developing action plans to either deal with the identified deficiencies within the scope of the agreement, renegotiate the agreement or initiate a new procurement. The assignment had many stakeholders and had to take into consideration clinical, commercial and legal perspectives. The noted deficiencies in the delivery had already caused delays in the project schedule and the analysis had to be done under considerable time pressure.
Aneheim Consulting created a Task Force with expertise in contract management, project planning, risk and scenario analysis as well as price and cost analysis. The work included visual planning, PEST analysis, workshops, market and procurement law analysis and long-term (10+ years) risk scenarios.
Based on the results of the Task Force, Stockholm county council made a decision to divide the existing agreement into three new agreements, one of which was reached through a negotiated procedure without prior announcement. Aneheim Consulting had the main responsibility for the preparation of contract documents and participated in all negotiations.
The agreement solution enabled the county council not to compromise the clinical needs at the same time as equipment could be delivered without any time impact on the clinical commissioning at the new radiotherapy facilities. Furthermore, the total contract values were kept within the original budget framework. The new contract structure ensured that this time the suppliers meet the county council's requirements and that further legal disputes could be avoided.
The result of Aneheim Consulting’s contribution led to a long-term collaboration with both suppliers. After completion of the assignment Aneheim Consulting was assigned to lead the contract implementation.
One of China's largest domestic insulin manufacturers was in the process of establishing a new manufacturing facility for its products. One of the company's goals was to adapt its business to eventually introduce their products on the European market and therefore they needed to meet EU’s GMP requirements. In connection with the opening of the new manufacturing site, a complete reorganization of the quality management system with focus on risk-based validation was initiated.
Team leaders who were to be trained in the new system had different backgrounds and experiences, and were unaccustomed to collaborating across line organization boundaries. Successful planning and management of the training would require flexibility and adaptation of the training material to all participants’ background knowledge.
Aneheim Consulting was hired in an advisory role in the change management of the quality management system and had a leading role in the development and implementation of the new procedures in the organization. An extensive needs assessment was carried out at an early stage, where a GAP analysis of existing quality management system was conducted to identify the necessary changes to meet EU’s strict GMP requirements.
The documents that were created were implemented through a comprehensive training package, including lectures and interactive workshops held for team leaders in the various departments of the organization. Training materials and document templates were developed to introduce risk-based validation principles and ICH guidelines. All the documentation was adapted for the customer.
Aneheim Consulting's initial analysis was a good basis for adapting the quality management system to the European GMP requirements. The training was considered successful and the customer was able to continuously implement templates and other documentation during the project's implementation phase. Since the participants were unaccustomed to working in a project organization, the many group exercises during the training played an important role in fulfilling the customer's desire to encourage their employees to work in cross-functional teams.
As the new framework for validation was harmonized with EU requirements, the customer was able to more effectively communicate with European suppliers during the project implementation and thereby also created the basis for a quality system fully in line with modern, risk-based principles.
A rapidly growing company in the energy sector was in the process of setting up a new site for testing and development of its product. From the beginning, the project was very time constrained as it was planned to carry out a Factory Acceptance Test (FAT) for a time-critical customer delivery at the new facility.
The work included contact with many stakeholders such as municipal associations, contractors and landlords. With a month to the planned FAT, there was still a small amount of installation work and an extensive job regarding safety, permits and functional testing before the operation could be started. Aneheim Consulting was hired to lead a Task Force with the goal of commissioning the new facility before the planned FAT.
Aneheim Consulting’s Task Force focussed on risk management, installation coordination, functional testing and documentation. Initially, a series of workshops, where risks were identified and a risk management plan established, were conducted. Remaining work was divided into work packages with clear division of responsibilities and included, among other things, a permit application from municipal associations and electricity distributors, safety work, financial monitoring and functional testing. During the course of the project, there was also a great need for gathering and organizing documentation to ensure that requirements from several parties were met and that the operation of the plant could proceed safely and efficiently after the project was completed.
As the project had a strict schedule, great emphasis was placed on communication with the management, the operational staff members and other stakeholders. Daily monitoring of progress was made by the visual planning boards that were implemented by the Task Force.
The site was commissioned in time for the planned FAT, which enabled several important customer deliveries to be made on time. Aneheim Consulting was given continued trust and was offered to take on the operational responsibility for the site during the start-up period and to work towards closing the project's remaining points, such as capacity and functional improvement measures, the development of work and safety routines and the establishment of service agreements. Following the successful deployment, Aneheim Consulting has been given the confidence to pursue further assignments with the client.