During a “friendly audit”, staff from other biobanks in the German Biobank Alliance (GBA) will in future audit each other once a year. Audits are a quality management tool and examine whether an organisation’s processes, requirements and guidelines meet the respective required standards. GBA’s first “friendly audits” are due to take place at the end of the year.
Exchange of experience between GBA biobanks
The “friendly audit” concept was developed by the Quality Management Coordinator Christiane Hartfeldt (German Biobank Node), Claudia Schuster and Sabrina Schmitt (BioMaterialBank Heidelberg), and Bettina Meinung (Integrated Biobank Jena), all of whom are members of the German Biobank Alliance’s QM core team. The concept is based on the ISO 19011 standard for auditing management systems. “Compared to hospital-internal audits, for instance, it offers the advantage that the auditors not only have a ‘view from the outside’, but also afford biobank-specific expertise,” explains Christiane Hartfeldt. “The audits foster the exchange of experience between staff at GBA biobanks.”
Auditors qualified during two-part training
GBA biobanks have selected staff to act as auditors – prerequisites included several years of professional experience in biobanking as well as expertise in quality management. The prospective auditors will now be qualified for the role during a two-part training course: in the first part of the training, basic knowledge of the ISO 19011 standard will be imparted during a three-day course held in June in cooperation with the TÜV Süd technical service organisation. Biobank-specific issues will then be covered in the second part of the training with experts, which is due to take place on two days in August. In a final practical examination, the participants will simulate an audit.
Cooperation with DZG, NAKO and BBMRI-ERIC
Representatives of the German Centres for Health Research (DZG) and the NAKO Health Study also count among GBA auditors. Intensive discussions were held with these two organisations in February 2018 during a GBN workshop on quality management. The European biobank network BBMRI-ERIC is involved in further development of the audit concept through its quality manager, Andrea Wutte. As the person responsible for the programme, Christiane Hartfeldt will continue to establish contact between auditors and biobanks and develop the schedules.