"Friendly audits" of the GBA-Biobanken
In the case of "friendly audits", employees of various biobank locations of the German Biobank Alliance (GBA) will audit each other once a year. Audits are instruments of quality management and examine whether processes, requirements and guidelines of an organization meet the required standards. The first "friendly audits" of the GBA are expected to take place at the end of the year.
Exchange of experience between GBA biobanks
The QM Core team of the German Biobank Alliance has developed the concept of "friendly audits" in the GBA. It is based on the ISO 19011 and 9001 standard for the auditing of management processes. "Compared, for example, to in-clinic audits, it offers the advantage that the auditors not only have an 'outside view' but also biobank-specific expertise," explains Christiane Hartfeldt, coordinator of quality management at the German Biobank Node. "The audits promote the exchange of experience between employees of the GBA biobanks."
Auditors qualify in two-part training
The GBA biobanks have selected employees for this purpose. Prerequisites for this activity were several years of professional experience in biobanking as well as knowledge in quality management. During a two-part further training, the future auditors will now be qualified: The first part of the training provided basic knowledge of the ISO 19011 and 9001 standard in a three-day course and was conducted in cooperation with TÜV Süd in June 2018. The second part dealt with biobank-specific topics taught by subject experts on two days in August. In a practical final exam, the participants simulated an audit.
Cooperation with DZG, NAKO and BBMRI-ERIC
GBA auditors also include members of the German Centers for Health Research (DZG) and the NAKO Health Study, with whom intensive discussions took place during a GBN workshop on quality management in February 2018. The European biobank network BBMRI-ERIC is involved with quality manager Andrea Wutte in the further work on the audit concept. As program officer, Christiane Hartfeldt continues to care about establishing contact between auditors and biobanks, as well as developing timetables.