Its fulfillment guarantees the systematic nature of the tasks, the traceability of the research and, most importantly, it is a contribution to improve the scientific quality of the research.
From August 14 to 16, our Institute organized an intensive training on Quality Systems Management in Research Laboratories. It was carried out within the Biomedicine Network of the Mercosur Structural Convergence Fund (FOCEM) of which the IBIoBA is a part. The specialist in charge was Saada Checker Fernández of the Oswaldo Cruz Foundation / FIOCRUZ (Brazil), a reference institution in Latin America in this growing discipline, and part of the Biomedicine Network.
Among the attendees were researchers and technicians from IBioBA and other biomedical research institutes of Buenos Aires.
The implementation of these management systems is still not frequent at research laboratories of the region. In order to implement them, it is required an institutional quality policy since it produces significant changes in the way of working, demands continuous training of all the members and also the constant permanent supervision of these practices.
It is necessary to adapt daily practices to the criteria established by national and international standards; but fundamentally, this new modality has an impact on resource management, research, documentation, publication and biosecurity, just to name a few. In all cases, the objective is to improve the scientific quality of research.
The preparation of these systems is far from being a one-sided imposition. On the contrary, to determine its effective fulfillment it is necessary that it be a collective construction in which people from different areas and with different roles participates to contemplate the multiplicity of perspectives and realities. “The communication is a crucial factor along the process and it is essential that members of all the boxes in the organization chart participates, suggest Chequer Fernandez.
This process underlies the search for transparency in research by registering genuine data. It is not about bureaucratizing daily work with forms to be completed, but about standardizing the greatest amount of practices in laboratories equally known by all its members.
In that sense, a quality system contemplates:
- Material resources
- Reproducibility and data trustworthiness
- Publishing policy
- Ethical implications
According to the specialist, all research projects, regardless of size and complexity, must: guarantee the trustworthiness and quality of data; register and save the results on a proper way (even if they are right or wrong) and, finally, determinate the opportune delivery of the results.
THE CORE PRINCIPLES OF QUALITY SYSTEM
This means that the institution should have the personnel information, the descriptions of the positions and the permanent training system for the teams properly updated.
It is important that the facilities have the necessary conditions to avoid mixing studies or cross contamination: “If there isn´t biosecurity, there is not quality” states Chequer Fernandez. The suitable environment to work requires to check the whole security system installed, to perform a detailed equipment maintenance and calibration and, finally, to define access control to the different areas of the building.
Similary, it must be contemplated the proper preservation of samples, files, reagents, registers, results or any other element that can influence the quality of the results: light, sterilization, dust, vapors, electromagnetic interference, radiation, humidity, power, temperature, sound levels and vibration.
Documentation and Reproducibility of data
To manage the quality system Standard Operating Procedures (SOPs) are produced that determine the guidelines for preparation, design, analysis and approval of research projects. The objective is to be able to reproduce the research from descriptive and prescriptive documents, on printed or electronic media, that include raw data, conditions of the equipment at the time of operation, decisions taken or people involved in each stage of the investigation.
The SOP´s advantages are:
- They unify practices.
- It allows the continuity of the tasks even if there were members rotation.
- It improves techniques and administrative procedures
- Enable the reconstruction of a study after many years.
- It works as a training manual.
- It serves as an audit document.
As for the possibility of reproducing the studies at any time or part of the world, even with other equipment, Saada Chequer Fernandez warns: “This is currently not possible because we do not have accurate information on the actual conditions in which the entire investigation process is carried out”. One way to verify this would be to involve internal and external quality control systems that include inter-laboratory testing, which would determine that the processes are providing comparable results in all organizations.
Quality at IBioBA
Offering the possibility to researchers from IBioBa, and other biomedical institutes, to train on these practices is a sign that institutional policies are the starting point for the implementation of quality systems.
In this regard, Eduardo Arzt, director of the IBioBa points out: “This training is another instrument to continue providing support for scientific excellence to the research carried out at the Institute. We understand that creating and formalizing quality management systems would give us a solid added value to our work. ”
ABOUT SAAADA CHEQUER FERNANDEZ
Since 2011 she works as Quality Coordinator in the FIOCRUZ units where she participated in internationally recognized processes. She participated in the Executive Committee and the Quality Management Committee of Fiocruz. She is member of the Quality Assurance Society (United States).