‘Audit’ – the mere mention of the word can strike fear into the heart of even the most experienced and organised of laboratory managers. Hours can be spent preparing for an external audit; collating information, formatting documents, and ensuring teams are equipped to handle any questions that may be directed towards them.
Sample tracking software or laboratory information management system (LIMS) to instil quality and traceability into your daily processes can help ease some of the administrative burdens around data management for audit compliance.
What if you were to go one step further and carry out your own internal audits?
Whatever the frequency, actively conducting your own internal quality checks on biospecimens and storage locations can help eliminate the traditional ‘audit rush/panic’.
Regular internal audits and quality checks allow you to confirm that the procedures and processes you have implemented are working effectively and allow for earlier identification of improvements and any necessary corrective actions.
They can help ease the tension that can be experienced around external audits. You and your team will be more confident demonstrating the quality processes and procedures you have in place and importantly, evidence their use.
In addition, your team will be well prepared and practised in the art of being audited and understand the significance of quality.
When deciding which areas to audit, it is important to ensure the critical information that will help you monitor and manage quality and be realistic. Some ideas of things to include in an internal audit are the:
- Random selection of biological samples collected over a defined period to confirm storage locations.
- Random selection of specimens collected over a defined period to check their use is within agreed consent restrictions.
- Random selection of donors that have withdrawn consent to confirm all biological samples have been destroyed and no longer in your biorepository in accordance with your Standard Operating Procedures (SOPs).
- Recording any compliance issues or required corrective action.
Tracking Outcomes and Progress
Integrated, interactive dashboards and reports can be used to monitor audit progress and outcome. Dashboards can include audits completed, results (pass/fail), outcome comparisons (versus last year or last quarter), trends and averages. This information can be evidenced in any external compliance audits such as those conducted by the Human Tissue Authority (HTA). In addition, it can be made available for your management reporting to monitor and measure biospecimen viability, track Return on Investment (ROI) and increase the value of your biological samples.
The benefit of this integrated approach means your system is set up for internal audits as and when you wish to perform them. The intuitive dashboard enables data to be continually organised in such a way that the auditing process becomes simply a reporting exercise with the information readily available and thus enabling you and your team to become more proactive.