Key Considerations for a Good Lab Investigation
When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence.
Before embarking on a career in Quality Assurance, I spent over six years in Research and Development for a company specialising in point-of-care in-vitro diagnostics. During my time there, I held various roles including laboratory technician, scientist, and manager and in these roles, I contributed to, supervised, and managed numerous laboratory investigations, many of which were highly complex and challenging.
Here, I have compiled some of my top tips to help you maximise the effectiveness of your laboratory investigations.
Data mining
Be prepared to ‘mine’ through a lot of data. Not only will you want to review records directly associated with the issue that instigated your investigation, but historical data is a key resource to help guide your investigation. Experiment or batch trackers – recording elements like operator, lot numbers, expiry dates, etc. – can prove so useful for reviewing data all in one place. If your organisation does not routinely use trackers as a means for indexing data, you may have to arduously sift through many previous experiments to compile this information, but it can be invaluable in helping you get to a root cause.
Good Documentation
Structured documentation that is kept up to date as the investigation progresses is key to not only producing detailed evidence of the work conducted but also allowing you to track experiments/data reviews that have been conducted as you go. This can be particularly useful if the investigation is complex with many people conducting different aspects of the work. If your organisation already has good, well-structured templates for documenting Quality Events or CAPAs this can be extremely useful, however, if not, make sure you are writing your report as you go to summarise events.
Tools
Tools at your disposal, such as Root Cause Analysis (RCA) techniques, which are employed by your company can help during the planning phase when you are trying to get ideas down on paper. Some common RCA tools include the 5 Whys, Fishbone Diagrams and Fault Tree Analysis.
Planning
You aren’t just going to run in and start your investigation with the first thing that springs to mind. A methodical, well-thought-out approach is best; first, look at listing possible root causes and think about what might be easiest or the most likely to investigate first and then, identify other tools or resources that might be needed to conduct your experiments. Spending the time to carefully plan out resources that will support your investigation will also ultimately prevent hold-ups; the last thing you want is to start an experiment in the lab only to realise you are missing key components to successfully complete it.
Deadlines
While it’s crucial not to rush an investigation, deadlines should be considered. These deadlines might be determined by organisational targets for getting Quality Events closed out or by the need to quickly resolve issues to restart production. Regardless of the driving force behind this, it is important to consider the deadlines when planning the necessary work, even if they aren’t initially met. Deadlines should drive the investigation forward and prevent it from falling off the radar, especially since the investigation is unlikely to be your sole focus of work.
Get the right people involved
Who are the stakeholders in your investigation? Are you going to need to communicate out with your department? You might also have to consult subject matter experts (SMEs) in a particular area to aid in your investigation, and equally, you may be the SME who may have to explain the complexities of your investigation to invested parties. Quality Assurance and Management should also typically be aware of your investigation to track and discuss progress, help identify the key stakeholders in the investigation, and ultimately review and approve the work conducted and any resulting actions to be implemented.
For Tower Mains, I prepare and deliver audits for GLP, GMP and GCP compliance and assist with analysing and improving research quality systems. Alongside this, I have co-developed and now co-deliver the ‘Conducting Laboratory Investigations’ course with Training Associate Erin Bell. In this course, we have used our experience and expertise to provide a detailed walkthrough of conducting a laboratory investigation. If you would like to find out when our next course date is, please email training@towermains.com.
Whether it’s training, audit or QA support, our expert team is on hand to provide comprehensive support and expert advice. For further information on what we can do for you or if you have any questions, please don’t hesitate to contact info@towermains.com.