Quality Management System in the BBMRI.pl Consortium: Status Before the Formation of the Polish Biobanking Network

Abstract

Many types of biomedical research projects depend on high-quality biological material with a data set attached. The Quality Management System (QMS) is focused on operational standards for all organizational activities to ensure that the described quality of each procedure, product, or service is guaranteed. The implementation of the QMS is necessary for the provision of both high quality and repeatability of processes in research laboratories. The current status of implementation of the QMS is determined according to the ''Organisation of Polish Biobanking Network'' within the project ''Biobanking and Biomolecular Resources Research Infrastructure BBMRI-ERIC'' supported by the Polish Ministry of Science and Higher Education-decision number DIR/WK/2017/01. According to the above, preliminary audits in six Polish institutions were conducted and reports with recommendations concerning the implementation and improvement of the QMS in Polish biobanks were prepared. During all audits, 13 QMS main areas were analyzed. All audited units belong to the BBMRI.pl consortium, which is responsible for the creation of the Polish Biobanking Network within the BBMRI-ERIC structure. Among all 13 analyzed areas, 27 deviations were identified. Eleven of them were implemented in all audited biobanks but defined as the areas for improvement, 16 of them were not implemented correctly or not implemented at all, respectively (areas underlined to corrective procedures).

Quality Management in Polish Biobanking Network—Current Status Before the Implementation of Unified and Harmonized Integrated Quality Management System

“…Cooperation in QM BBMRI-ERIC WGs, the Polish Committee for Standardization in TC 287 Biotechnology and ISO TC 276 WG2 and WG4 provides the best knowledge on standards dedicated to biobanking. The previously determined 13 areas ( 14 ) were modified as follows: (1) Training was added to Human Resources Management , (2) Traceability of technical and technological processes, Controlled storage process were combined within one area of Traceability , (3) Strategic and operational objectives were added to Quality Management , (4) Quality control of deliveries were changed to Supplies, material management , (5) Monitoring of environmental conditions and Handling of hazardous waste were combined in one area of Environmental and staff hygiene . Some other areas were also changed or added, which resulted in the establishment of 15 areas (similar to QSPB) (1) Management of Biobanks , (2) Quality management , (3) Documentation and records , (4) Human Resources Management , (5) Ethical and Legal Aspects-ELSI , (6) Supplies, materials management , (7) Equipment , (8) Traceability , (9) Environmental and staff hygiene , (10) Biobanking processes and quality control , (11) Deviations, non-conforming product/data or service , (12) Audits , (13) Improvement , (14) Biobank cooperation in the scientific, research and development area and (15) Safety&Security .…”

“…Also within BBMRI.pl project ( 12 ), Quality Standards for Polish Biobanks (QSPB) were established as common standards for Polish Biobanking Network (PBN) entities ( 13 ). Moreover, a unified QMS audit process was invented and consistently implemented.…”

“…The main purpose of the work was to check the current state of QMS and the processes taking place in biobanks that belong to PBN. Based on the previous work, where the general audit areas were established, 15 dedicated areas were defined and analyzed ( 14 ). As an outcome, the possibility of a detailed analysis of the QMS level implementation in the PBN biobanks was created.…”

The landscape of biobanks in Poland—characteristics of Polish biobanking units at the beginning of BBMRI.pl organization

“…Such a unit uses the collected resources in multiple and long-term ways, with specific procedures to preserve the high quality of collected resources and protect the rights of donors, as well as having an appropriate supervisory body in the form of a scientific and ethical committee for biobanking [ 8 – 10 ]. Biobank should meet several requirements criteria that define, e.g., the mission and the scope of its activities [ 8 , 11 , 12 ]. It should also be emphasized that the proper functioning of a biobank requires employing well-qualified and well-selected personnel [ 13 ].…”

“…Polish law does not provide legislative rules for the correct operation of biobanks. To ensure the best standards for obtaining, storing, and working with biological material, it is crucial to ensure the harmonization of biobanks [ 1 , 12 , 19 , 26 ]. This phenomenon indicates the need to create networks that could standardize the quality management system for biobanks [ 1 , 19 ].…”