Have you failed your laboratory audit?

The key factors you need to consider 

Independent audits of clinical and diagnostic laboratories, carried out under GCP, GLP or similar regimes, can be stressful. They also tie up considerable time and staff resources; and if you fail your audit it can have serious consequences. 

At best, a failure will require time and effort to rectify the problems; at worst, failure can lead to reputational damage, disqualification of data or test results, or even a suspension of your license to operate.

The good news is that, with the correct approach, stress levels, time and staff utilization can all be reduced.  Just as importantly, by using the correct tools and processes you can be confident that you’ll pass your next audit. 

Before considering these tools, it’s worth considering why laboratories fail GLP or GCP audits. 

Why do laboratories fail GCP/GLP audits?

Although there can be many different factors that lead to audit failure, in general terms they fall into five categories:

• Failures in GCP or GLP process.  Maintaining best practice under GLP and GCP to ensure that test and analysis processes are followed consistently can be complex; it requires, for example, fully documented procedures, effective staff training and attention to detail at all times.  Processes generally break down incrementally or are caused by lack of adherence to documented quality procedures.
• Failures in the chain of custody, typically involving poor tracking and handling of samples.  Often the cause is over-dependence on – and poorly managed – manual tracking and data logging procedures.
• Lack of control over change documentation; for example, where changes made during testing or analyses procedures are incorrectly recorded, or fail to be recorded.
• Errors in transcription, normally due to human errors arising from lack of time, poor attention to detail or simple laziness.
• Out of tolerance process outcomes caused by human interference or equipment malfunction; although human interference is rarely deliberate, even unintentional interference affecting the integrity of processes can be cause for audit failure, while an undetected fault in for example a storage fridge can affect test results, again with potentially adverse consequences.

How to avoid GLP/GCP audit failure 

Assuming that you already have the basics in place – fully documented procedures, recognized and correctly maintained processes, and comprehensive training and quality monitoring structures – then it is time to consider ways to eliminate or minimize the root cause of most audit failures: human error.

One option is to make use of the growing number of automated and semi-automated laboratory systems, together with recording methods based on barcode scanning.

An area that is often overlooked is the process of data capture and analysis required to ensure that laboratory equipment such as fridges, freezers, incubators, autoclaves and test chambers is functioning within specification.  In many instances, this data is still recorded manually.  This is a time-consuming process, requiring staff resources that could be better deployed elsewhere in the laboratory and, most critically, is prone to human error.

The solution is to replace manual data gathering with a centralized system that captures and analyzes data from laboratory systems in real time. Our  real-time monitoring solutions platform (RMS) for example frees-up staff resources and provides a fully documented, traceable record that complies with all GLP/GCP requirements.  It also delivers immediate alerts if equipment deviates from set parameters, so that remedial action can be taken immediately, providing peace of mind and helping to ensure a successful outcome for future audits.

Laboratories can adopt a risk-based inspection program and will need to have documented risk assessments. These will identify the issues that might compromise compliance and patient safety and evaluate the risks associated with exposure to those issues.

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Author:
James Pickering, Director of Environmental Monitoring Systems