Introduction
In biobanking, a quality system can look flawless on paper yet fail when specimens move through collection, processing, and storage. We spoke with the team at Global Biospecimen Partners about when quality systems break down, what assessments often miss, and how to build a quality system from the ground up. Their answers offer practical guidance for anyone responsible for specimen integrity and research readiness.
When a "Fine" Quality System Isn't
We asked when a biobank was told its quality system was fine, only to discover it wasn't. The response pointed to problems that surface downstream.
"I’ve seen situations where the quality system looked adequate, but problems only became obvious when we examined what was happening downstream."
In one multi-site project, sequencing and genotyping failure rates rose sharply. Investigation traced the issue to sample collection and processing practices at a single site. Although protocols existed, handling at that site compromised results. Correcting and standardising collection and processing procedures improved performance.
On another occasion, unexpectedly low DNA yields were traced to an incorrect sample collection tube—an issue that arose before samples even reached the laboratory for extraction.
"Both experiences reinforced something important for me: you cannot assess a biobank’s quality system by reviewing its documents alone."
The lesson: understanding how samples are actually collected, handled, processed, and stored—and whether downstream results match what the system promises—is essential. When performance deteriorates, you need to trace the problem back through the specimen lifecycle.
What General Guidance Misses
We asked what keeps coming up in biobank assessments that general quality and compliance guidance leaves out. The answer focused on the gap between having individual procedures and making them work together.
Temperature monitoring is a clear example. A biobank may have an SOP for freezer monitoring, but what happens when an ultra-low-temperature freezer has an excursion outside working hours? Who receives the alert? Who responds? How is the incident documented, and how are affected specimens assessed before use?
"These are connected questions. Monitoring alone is not enough if nobody responds appropriately to an alarm, and documenting an incident is not enough if the potential impact on the specimens is never assessed."
Similar connections appear across specimen identification, chain of custody, staff competency, equipment maintenance, and data integrity. During an assessment, reviewing SOPs is only part of the work. You also need to speak with staff, observe workflows, check equipment and records, and establish whether controls work as intended.
At Global Biospecimen Partners, the approach is structured and risk-based. The goal is to understand not only what a biobank has documented, but where processes are vulnerable, what the consequences could be, and which gaps need attention first.
Building a Quality System from Scratch
Finally, we asked what to put in place before anything else when setting up a biobank's quality system. The starting point is defining the biobank's purpose, the specimens it will handle, and the research applications those specimens will support. Those decisions determine which processes, facilities, equipment, and quality controls are required.
From there, five areas take priority:
- Governance and accountability. Clear responsibilities for quality, defined authority to manage deviations, and a process for escalating problems.
- Specimen identification and traceability. A reliable system to track every specimen throughout its lifecycle, with records of custody and handling.
- Collection and processing procedures. Standardised workflows appropriate to each specimen type, with critical steps verified or validated as appropriate to the process and its risks.
- Storage and environmental control. Suitable facilities, equipment monitoring, and tested response procedures for power failures, temperature excursions, and other disruptions.
- Deviation and corrective-action management. A practical way to document problems, investigate causes, implement corrective actions, and check whether those actions worked.
"I would use ISO 20387 and relevant ISBER Best Practices to inform the system’s design, while tailoring the implementation to the biobank’s intended purpose, risk profile, resources, and applicable requirements."
The objective is a system that protects specimen integrity, maintains traceability, and provides evidence that specimens are fit for their intended research use.
Key Takeaways
- Document review alone cannot confirm a quality system works; observe actual workflows and downstream results.
- Connect individual procedures—monitoring, response, documentation, and impact assessment—so they function as a whole.
- Start with purpose and intended use, then build governance, traceability, collection and processing, storage, and corrective-action processes.
- Use frameworks like ISO 20387 and ISBER Best Practices as guides, tailored to your risk profile and resources.
For biobanks aiming to strengthen their systems, these insights offer a practical path from documentation to dependable performance.