Quality Management and Quality Systems in Regea
Regea quality management consists of practices assuring the quality of research, tissue bank processes, stem cell production, societal impact and interaction, personnel resources, administrative activities and management. Quality management practices cover all the processes and all the organization levels in Regea, e.g. management, group leaders, administration, research personnel and laboratory staff. Regea quality management is grounded on the principle that the same people and groups that are responsible for the maintenance and development of certain activities are also responsible for the quality assurance and the setting up of different quality systems for these activities.
Regea quality management is guided by following principles and practices:
- The personnel have been informed on the quality systems and quality assurance practices regarding different processes. The whole personnel are involved in the development of the quality systems.
- The essential parts and processes relating to quality assurance have been documented. The quality and amount of documentation needed is related to the prerequisites of the process. The documentation is evaluated and updated regularly.
- Internal and external audits are used in the development work.
- Information on different processes is delivered actively. Inner training, faculty meetings and group meetings have an important role in informing the personnel.
Regea quality systems are presented below. The systems support each other and are, in many cases, overlapping. Because of the different requirements/standards/legislation, the different systems are represented separately.
1. Quality management of the administration and research
Essential practices assuring the quality on institute level are e.g. systematic familiarization of new employees, a detailed specification of each employee’s responsibilities, informing the personnel on matters pertaining to the department and the personnel, and regular reports on well-being at work. The most important processes assuring the quality of research are regular external audits on research activities as well as national and international research cooperation.
2. Information Security
Information security in Regea is built according to ISO27001 standard. The most important matters relating to information security are electronic information security, physical security and personnel training on different parts of the information security.
3. GXP Systems
GXP systems refer to formal quality systems used in the pharmaceutical industry. Their scope and contents are defined in legislation (GLP=Good Laboratory Practice, GMP=Good Manufacturing Practice, among other things). GMP regulations are applied in the production of stem cells for patient use (in applicable parts). Regarding clinical tissue banking processes, the legislation concerning tissue establishments requires a quality system similar to GMP principles. GXP systems require, for example, an organization chart and specification of responsibilities, precise standard operation procedures for each step of the process, the quality assurance tests and analyses for materials, products and production environment, documenting all processes and a complete traceability of employees involved in each step of the processes.
Regea personnel continuously develop and estimate its quality assurance activities. The focus of the development work is linked to the relatively young age of the institute and the rapid growth of its operations during its first years of operation. During the following two years, the focus is on closer specifying each employee’s responsibilities, charting and developing personnel know-how profiles, enhancing the information flow inside Regea and building quality assurance processes for new GXP products.
